Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
Spine CAMP™ (1.1)
Medical Metrics, Inc.
Authorized purpose: Analyze spine X-rays to produce static and/or motion metrics from sagittal lumbar and/or cervical radiographs, visualize intervertebral motion through image-registration stabilization, and support assessment of spinal stability, alignment, degeneration, fusion, motion preservation, and implant performance in skeletally mature patients aged 18 years and older.
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: Analyze spine X-rays to produce static and/or motion metrics from sagittal lumbar and/or cervical radiographs, visualize intervertebral motion through image-registration stabilization, and support assessment of spinal stability, alignment, degeneration, fusion, motion preservation, and implant performance in skeletally mature patients aged 18 years and older.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Analyze spine X-rays to produce static and/or motion metrics from sagittal lumbar and/or cervical radiographs, visualize intervertebral motion through image-registration stabilization, and support assessment of spinal stability, alignment, degeneration, fusion, motion preservation, and implant performance in skeletally mature patients aged 18 years and older.
- Which images or clinical context are in scope? Modality: X-ray/Radiography Anatomy or clinical context: Spine, including sagittal lumbar and cervical spine; femoral-head landmarks for spinopelvic measurements Input: DICOM X-ray images of the spine, specifically sagittal-plane lumbar and/or cervical radiographs, from skeletally mature patients aged 18 years and older.
- Who uses it? Intended users: Qualified and licensed professional healthcare practitioners or trained professionals
- What does the software produce? Output: Reports containing static and motion metrics, including distances, angles, linear and angular displacements and combinations; vertebral landmark coordinates, image calibration, intervertebral and spinopelvic measurements, annotated images, and visualizations of intervertebral motion through stabilization.
- What is its most important limitation? Key limitation: The software is fully automated for analysis but human intervention is required for interpretation. The FDA indication is limited to the described sagittal lumbar/cervical spine radiographs and skeletally mature patients aged 18 years and older. The submission includes bench/performance testing and no clinical data; the FDA packet does not establish a specific current PACS, RIS, EHR, or deployment configuration.
Clinical takeaway
Clinical role: Analyze spine X-rays to produce static and/or motion metrics from sagittal lumbar and/or cervical radiographs, visualize intervertebral motion through image-registration stabilization, and support assessment of spinal stability, alignment, degeneration, fusion, motion preservation, and implant performance in skeletally mature patients aged 18 years and older.
Evidence takeaway
Evidence from the reviewed source record: FDA K231668 reports software verification and validation on datasets not used to train the AI models. Additional bench testing used 215 lateral cervical-spine radiographs and 232 lateral lumbar-spine radiographs, analyzed by five experienced operators using the QMA reference device for spinopelvic measurements. Correlation and statistical equivalence were demonstrated for vertebral landmark coordinates, image calibration, intervertebral measurements, and spinopelvic measurements. The clinical-data section is not applicable and no clinical data are included.
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
- Analyze spine X-rays to produce static and/or motion metrics from sagittal lumbar and/or cervical radiographs, visualize intervertebral motion through image-registration stabilization, and support assessment of spinal stability, alignment, degeneration, fusion, motion preservation, and implant performance in skeletally mature patients aged 18 years and older.
- Intended users
- Qualified and licensed professional healthcare practitioners or trained professionals
- Care setting and population
- Adult clinical radiology or orthopedic workflow; the FDA packet specifies skeletally mature patients aged 18 years and older but not a facility type
- Workflow role
- Server-based post-processing measurement and 2D motion analysis of sagittal spine X-rays, including vertebral landmarking, image registration/stabilization, spinopelvic measurements, and clinical reporting with required human interpretation.
- Required input
- DICOM X-ray images of the spine, specifically sagittal-plane lumbar and/or cervical radiographs, from skeletally mature patients aged 18 years and older.
- Output and human action
- Reports containing static and motion metrics, including distances, angles, linear and angular displacements and combinations; vertebral landmark coordinates, image calibration, intervertebral and spinopelvic measurements, annotated images, and visualizations of intervertebral motion through stabilization.
- Limitations
- The software is fully automated for analysis but human intervention is required for interpretation. The FDA indication is limited to the described sagittal lumbar/cervical spine radiographs and skeletally mature patients aged 18 years and older. The submission includes bench/performance testing and no clinical data; the FDA packet does not establish a specific current PACS, RIS, EHR, or deployment configuration.
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 device runs on a server and accepts DICOM images, with reports, annotated images, and motion visualizations as outputs. Exact PACS/RIS/EHR interfaces, versions, routing, and current deployment details are not established by the FDA packet.
- Deployment and data flow
- On-premise
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
- Security and privacy
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Spine CAMP™ (1.1); FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · 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
- FDA K231668 reports software verification and validation on datasets not used to train the AI models. Additional bench testing used 215 lateral cervical-spine radiographs and 232 lateral lumbar-spine radiographs, analyzed by five experienced operators using the QMA reference device for spinopelvic measurements. Correlation and statistical equivalence were demonstrated for vertebral landmark coordinates, image calibration, intervertebral measurements, and spinopelvic measurements. The clinical-data section is not applicable and no clinical data are included.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
This field has not been curated yet.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Spine CAMP™ (1.1) regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K231668
- Samplen=447
- IndependenceIndependence not established
K231668
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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
- Vendor documentation pending
No public price or quote for the exact K231668 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
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-identifier FDA recall query returned no native recall record for K231668. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K231668 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-20Last searched
23Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. 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, fda device recall, literature index, trial registry, 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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FDA K231668: Spine CAMP™ (1.1)
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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Spine CAMP™ (1.1) model card (K231668)
Scope: intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K231668
Scope: postmarketSafety
Research history
-
K231668 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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