Exact API-to-client workflow
The exact submission describes an API that routes image data to cloud machine-learning modules and returns detection metadata to a Windows client for editable polygon rendering.
exact submission · checked 2026-09-08FDA-cleared profile
Second Opinion CC
Pearl Inc.
Authorized purpose: Second Opinion CC assists dental health professionals as a second reader for caries on bitewing and periapical radiographs of permanent teeth in patients 19 years or older, displaying editable polygonal contours for clinician review; it does not replace a complete dentist review or clinical judgment.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Second Opinion CC assists dental health professionals as a second reader for caries on bitewing and periapical radiographs of permanent teeth in patients 19 years or older, displaying editable polygonal contours for clinician review; it does not replace a complete dentist review or clinical judgment.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Second Opinion CC assists dental health professionals as a second reader for caries on bitewing and periapical radiographs of permanent teeth in patients 19 years or older, displaying editable polygonal contours for clinician review; it does not replace a complete dentist review or clinical judgment.
- Which images or clinical context are in scope? Modality: X-ray/Radiography Anatomy or clinical context: Dental/Maxillofacial Input: Digital intraoral bitewing and periapical radiographs of permanent teeth in patients aged 19 years or older, sent through the application programming interface for cloud processing.
- Who uses it? Intended users: Dental health professionals, including dentists, who review the radiograph, image findings, patient history, and in-vivo clinical assessment.
- What does the software produce? Output: Machine-generated detection metadata rendered as editable polygonal overlays on the original radiograph to identify teeth and suspected carious lesions requiring clinical review.
- What is its most important limitation? Key limitation: Exact K242522 labeling is limited to caries contouring on bitewing and periapical permanent-tooth radiographs for patients 19 years or older. It does not establish panoramic use or detection of the broader findings advertised for the current Second Opinion family. False positives and false negatives remain possible, and a complete dentist review is required.
Clinical takeaway
Clinical role: Second Opinion CC assists dental health professionals as a second reader for caries on bitewing and periapical radiographs of permanent teeth in patients 19 years or older, displaying editable polygonal contours for clinician review; it does not replace a complete dentist review or clinical judgment.
Evidence takeaway
Evidence from the reviewed source record: K242522's 500-image standalone comparison evaluates caries localization by polygon contours versus the predicate's bounding boxes. Endpoint definitions, image mix, lesion count, and false-positive burden are retained so the 90% sensitivity is not interpreted in isolation.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- Second Opinion CC assists dental health professionals as a second reader for caries on bitewing and periapical radiographs of permanent teeth in patients 19 years or older, displaying editable polygonal contours for clinician review; it does not replace a complete dentist review or clinical judgment.
- Intended users
- Dental health professionals, including dentists, who review the radiograph, image findings, patient history, and in-vivo clinical assessment.
- Care setting and population
- Dental practices reviewing eligible permanent-tooth bitewing and periapical radiographs for patients aged 19 years or older.
- Workflow role
- Cloud-processed caries detection and localization as a second reader, with editable findings rendered in the client interface; final diagnosis and treatment decisions remain with the dentist.
- Required input
- Digital intraoral bitewing and periapical radiographs of permanent teeth in patients aged 19 years or older, sent through the application programming interface for cloud processing.
- Output and human action
- Machine-generated detection metadata rendered as editable polygonal overlays on the original radiograph to identify teeth and suspected carious lesions requiring clinical review.
- Limitations
- Exact K242522 labeling is limited to caries contouring on bitewing and periapical permanent-tooth radiographs for patients 19 years or older. It does not establish panoramic use or detection of the broader findings advertised for the current Second Opinion family. False positives and false negatives remain possible, and a complete dentist review is required.
Regulatory identity
FDA record and catalog context
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The exact device contains an API, machine-learning modules, and a client interface: images and metadata pass through the API to cloud-based processing and detections return as metadata for interface rendering. Exact connectors and supported practice systems are not listed in the FDA summary.
- Deployment and data flow
- Cloud-based processing with a Windows client environment, as described in the exact FDA substantial-equivalence comparison.
Current hosting region, tenancy, retention, service levels, and exact client requirements require vendor confirmation.
- Security and privacy
- The exact FDA summary states that Pearl developed security controls and development/postmarket processes using the FDA's September 2023 premarket cybersecurity guidance and December 2016 postmarket cybersecurity guidance. It does not disclose the control scope, audit evidence, data flow, retention, or assurance period needed for procurement.
- Training and support
- Vendor documentation pending
Role-based onboarding, clinical-use training, competency assessment, support terms, and retraining after updates were not established.
- Monitoring and change control
- Monitor patient-age and image-type eligibility, upload and processing failures, result latency, contour edits, false positives per image, false-negative review, dentist/AI disagreement, downstream treatment acceptance, update control, complaints, cybersecurity events, and exact-submission recalls.
Buyer acceptance guidance derived from the exact workflow, risk description, and performance endpoints; it is not a claimed vendor monitoring service.
Current Second Opinion family integrations
Pearl's current Second Opinion page describes native integrations with more than 40 imaging and practice-management systems plus a standalone web app, with vendor-led setup. This is family context and does not establish connector or feature availability for the exact K242522 configuration.
product family · checked 2026-09-08Current family processing workflow
Pearl's current page says most current-family images load in under one minute and includes bitewing, periapical, and panoramic workflows across many findings. Only the exact K242522 caries, bitewing/periapical, permanent-teeth, and age-19+ scope is applicable to this dossier.
product family · checked 2026-09-08Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
- Evidence summary
- K242522's 500-image standalone comparison evaluates caries localization by polygon contours versus the predicate's bounding boxes. Endpoint definitions, image mix, lesion count, and false-positive burden are retained so the 90% sensitivity is not interpreted in isolation.
- Reported sensitivity
- Lesion-level sensitivity 90% (95% CI 87%-94%) at Jaccard index 0.4
- Reported specificity
- Research pending
This field has not been curated yet.
Weighted alternative free-response ROC figure of merit
0.81 wAFROC FOM
- EndpointCaries localization non-inferiority using polygonal contours at Jaccard index 0.4
- Population500 dental radiographs: 249 periapical and 251 bitewing; 212 contained caries and 356 ground-truth lesions were marked
- Tested versionSecond Opinion CC caries-contouring configuration described in K242522
Highest-rated ROC area under curve
0.88 HR-ROC AUC
- EndpointSecondary caries-detection comparison against polygonal consensus ground truth
- Population500 dental radiographs: 249 periapical and 251 bitewing
- Tested versionSecond Opinion CC caries-contouring configuration described in K242522
Lesion-level sensitivity
90 percent
- EndpointCaries lesion localization with overlap at or above Jaccard index 0.4
- Population500 radiographs containing 356 ground-truth caries lesions across 212 abnormal images
- Tested versionSecond Opinion CC caries-contouring configuration described in K242522
Average false positives per image
1.34 false positives per image
- EndpointPredicted regions without ground-truth overlap at or above Jaccard index 0.4
- Population500 dental radiographs
- Tested versionSecond Opinion CC caries-contouring configuration described in K242522
K242522 Second Opinion CC standalone non-inferiority study
- DesignStandalone non-inferiority comparison of polygonal Second Opinion CC with the bounding-box Second Opinion predicate using four-reader consensus ground truth and wAFROC as the primary efficacy paradigm.
- Population500 images: 249 periapical and 251 bitewing; 212 caries-positive images with 356 lesions. The age metadata included 9 images from ages 12-18, 233 from ages 18-75, 13 from ages 75+, and 245 with unknown age despite labeling for patients 19 years or older.
- Scopeexact submission
- Tested versionSecond Opinion CC caries-contouring configuration described in K242522
- Samplen=500
- IndependenceSponsor or vendor study
K242522
Manufacturer-submitted regulatory evidence. The age-distribution mismatch and large unknown-age share should be addressed during local evidence review; the FDA summary does not provide a subgroup result for the labeled 19+ population.
Costs and setup
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Not established in reviewed sources
No public exact-product amount, pricing unit, term, minimum, implementation fee, or support inclusion was established.
- Reimbursement and coding
- Not established in reviewed sources
Pearl's patient-facing blog says AI is typically not separately billed, but it is not payer policy and does not establish product reimbursement or underlying-service coverage.
No product-specific code
Pearl states in a patient-facing article that AI analysis is typically incorporated into routine dental diagnostic care and not billed separately; this is a vendor generalization, not an exact-product payer policy or coverage determination.
General dental insurance context stated by Pearl · United StatesDo not infer reimbursement, patient cost, or contract pricing. Verify each payer, plan, underlying exam/X-ray benefit, provider agreement, and billing practice.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
- Postmarket safety review
- The exact-submission FDA recall query returned no native recall record for K242522. This limited query does not establish absence of recalls or other safety information.
Buyer worksheet
Open questions to take to the vendor
- Verify training: Role-based onboarding, clinical-use training, competency assessment, support terms, and retraining after updates were not established.
- Verify pricing and total cost: No public exact-product amount, pricing unit, term, minimum, implementation fee, or support inclusion was established.
- Verify reimbursement and coding relevance: Pearl's patient-facing blog says AI is typically not separately billed, but it is not payer policy and does not establish product reimbursement or underlying-service coverage.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-08Last searched
25Fields reviewed
12Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
Stored PubMed and ClinicalTrials.gov candidate arrays were empty. No paper or trial was promoted; empty arrays do not establish absence of external evidence. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, acr ai central product, vendor product page, vendor patient education, fda device recall, literature index, trial registry, stored candidate metadata, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history
Source ledger
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K242522 FDA decision source
Scope: regulatoryIdentity, purpose, modality, anatomy
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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Second Opinion CC model card (K242522)
Scope: purpose, modality, intendedUsers, careSetting, output, evidenceSummary, anatomy, evidenceStudies
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
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openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
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FDA 510(k) K242522: Second Opinion CC
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, security
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Second Opinion real-time dental pathology detection
Scope: productFamily, clinicalWorkflow, integrations, implementationCapabilities
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Dental check-up appointment with AI: cost and insurance considerations
Scope: vendorEconomicsContext, patientFees, insuranceContext
-
openFDA exact recall query for K242522
Scope: postmarketSafety
Research history
-
K242522 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
human reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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