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
CINA-ASPECTS
Avicenna.AI
Authorized purpose: CADx assistance for assessment and characterization of brain tissue abnormalities and early ischemic injury in patients with known MCA or ICA occlusion, using ASPECTS regions and scoring to evaluate extent of disease during image interpretation.
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: CADx assistance for assessment and characterization of brain tissue abnormalities and early ischemic injury in patients with known MCA or ICA occlusion, using ASPECTS regions and scoring to evaluate extent of disease during image interpretation.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: CADx assistance for assessment and characterization of brain tissue abnormalities and early ischemic injury in patients with known MCA or ICA occlusion, using ASPECTS regions and scoring to evaluate extent of disease during image interpretation.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Brain, including ASPECTS regions Input: Non-contrast head CT images in DICOM-compatible clinical imaging workflow from patients over 21 with known unilateral MCA or ICA occlusion, within 12 hours from time last known well, acquired on Canon, GE, Philips, or Siemens scanners; the clinician must confirm the LVO condition before results are available.
- Who uses it? Intended users: Neuroradiologists and clinicians, including stroke neurologists, general radiologists, neurointensivists, and vascular neurologists.
- What does the software produce? Output: An automatic ASPECTS score reflecting the number of affected regions, delineated and highlighted ASPECTS ROIs, a heat map of contributing voxels, region labels, underlying voxel values, and DICOM output for PACS or workstation review; the clinician can adjust the score.
- What is its most important limitation? Key limitation: Not intended for primary CT interpretation. It is validated and intended for known unilateral MCA or ICA occlusion, brain ischemia within 12 hours from last known well, patients over 21, and the listed Canon, GE, Philips, and Siemens scanner families. It is not suitable for tumors, abscesses, traumatic brain injury, hemorrhagic transformation, or hematoma; excessive motion, streak artifact, or significant noise can make scans technically inadequate.
Clinical takeaway
Clinical role: CADx assistance for assessment and characterization of brain tissue abnormalities and early ischemic injury in patients with known MCA or ICA occlusion, using ASPECTS regions and scoring to evaluate extent of disease during image interpretation.
Evidence takeaway
Evidence from the reviewed source record: FDA standalone testing used a retrospective, multicenter, multinational, multi-vendor, blinded study of CINA-ASPECTS v1.5 with 200 anonymized NCCT cases from five sites in the US and France, four scanner makers, and 27 models; the dataset was separated from training/testing data. The MRMC study used eight readers, four expert neuroradiologists and four non-experts, each scoring 10 regions in the 200 cases. Readers agreed with almost one-half region more per scan with the device, 4.1% (95% CI 3.3%-4.9%); overall reader ROC AUC improved from 0.75 unaided to 0.79 aided, and mean time per case decreased. These are reader agreement, reader ROC, and workflow-time endpoints, not device sensitivity or specificity.
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
- CADx assistance for assessment and characterization of brain tissue abnormalities and early ischemic injury in patients with known MCA or ICA occlusion, using ASPECTS regions and scoring to evaluate extent of disease during image interpretation.
- Intended users
- Neuroradiologists and clinicians, including stroke neurologists, general radiologists, neurointensivists, and vascular neurologists.
- Care setting and population
- Clinical or hospital environment operating in parallel with standard care.
- Workflow role
- Post-acquisition NCCT preprocessing, tilt correction, predefined-ROI analysis, and automatic ASPECTS scoring; the clinician confirms the occlusion prerequisite, reviews and edits the result, and archives the final output.
- Required input
- Non-contrast head CT images in DICOM-compatible clinical imaging workflow from patients over 21 with known unilateral MCA or ICA occlusion, within 12 hours from time last known well, acquired on Canon, GE, Philips, or Siemens scanners; the clinician must confirm the LVO condition before results are available.
- Output and human action
- An automatic ASPECTS score reflecting the number of affected regions, delineated and highlighted ASPECTS ROIs, a heat map of contributing voxels, region labels, underlying voxel values, and DICOM output for PACS or workstation review; the clinician can adjust the score.
- Limitations
- Not intended for primary CT interpretation. It is validated and intended for known unilateral MCA or ICA occlusion, brain ischemia within 12 hours from last known well, patients over 21, and the listed Canon, GE, Philips, and Siemens scanner families. It is not suitable for tumors, abscesses, traumatic brain injury, hemorrhagic transformation, or hematoma; excessive motion, streak artifact, or significant noise can make scans technically inadequate.
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
- A standalone executable can run from the command line or through medical image communications devices; it does not interface directly with CT scanners or data-collection equipment. Results are stored in DICOM for transfer to PACS or a workstation, with exact interface versions and local compatibility not established.
- 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.
Result destination
PACS and workstation are explicitly referenced as a result destination.
exact submission · checked 2026-09-01Confirm supported products, versions, routing behavior, and display requirements during local evaluation.
Supported acquisition environment
Scanner manufacturers: Canon/Toshiba;GE;Philips;Siemens
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for CINA-ASPECTS; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-09Evidence
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 standalone testing used a retrospective, multicenter, multinational, multi-vendor, blinded study of CINA-ASPECTS v1.5 with 200 anonymized NCCT cases from five sites in the US and France, four scanner makers, and 27 models; the dataset was separated from training/testing data. The MRMC study used eight readers, four expert neuroradiologists and four non-experts, each scoring 10 regions in the 200 cases. Readers agreed with almost one-half region more per scan with the device, 4.1% (95% CI 3.3%-4.9%); overall reader ROC AUC improved from 0.75 unaided to 0.79 aided, and mean time per case decreased. These are reader agreement, reader ROC, and workflow-time endpoints, not device sensitivity or specificity.
- 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.
CINA-ASPECTS regulatory performance study summary
- DesignStand-alone performance and reader study (ACR AI Central category)
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K233342
- Samplen=200
- Sites5
- IndependenceIndependence not established
K233342
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 K233342 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 K233342. 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 K233342 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
1Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains 1 PubMed and 0 ClinicalTrials.gov candidate record. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 1 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 K233342: CINA-ASPECTS
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
CINA-ASPECTS model card (K233342)
Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K233342
Scope: postmarketSafety
Research history
-
K233342 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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