Radiology AI Directory

FDA-cleared profile

CINA-CSpine

Avicenna.AI

Authorized purpose: Assist hospital networks and appropriately trained physician specialists by flagging suspected acute cervical-spine fractures on cervical-spine CT for triage and prioritization; it is not designed to detect vertebral compression fractures.

MSK and boneDetection and CADeAcute triage and notification
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: Assist hospital networks and appropriately trained physician specialists by flagging suspected acute cervical-spine fractures on cervical-spine CT for triage and prioritization; it is not designed to detect vertebral compression fractures.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Assist hospital networks and appropriately trained physician specialists by flagging suspected acute cervical-spine fractures on cervical-spine CT for triage and prioritization; it is not designed to detect vertebral compression fractures.

Evidence takeaway

Evidence from the reviewed source record: FDA retrospective multicenter, multinational, blinded standalone testing used 328 anonymized cases, including 155 positive and 173 negative cases, with ground truth by consensus of three U.S.-board-certified expert radiologists. Sensitivity was 90.3% (95% CI 84.5%-94.5%) and specificity was 91.9% (95% CI 86.8%-95.5%). Mean time to notification for all cases was 2.9 minutes (95% CI 2.7-3.0; median 2.6; range 1.0-6.8); for 140 true-positive cases, mean time was 2.8 minutes (95% CI 2.6-3.0).

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
Assist hospital networks and appropriately trained physician specialists by flagging suspected acute cervical-spine fractures on cervical-spine CT for triage and prioritization; it is not designed to detect vertebral compression fractures.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Hospital networks and appropriately trained physician specialists.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Hospital radiology worklist and image-communication workflow operating in parallel with standard of care.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Parallel CT triage and notification that marks suspected cases for earlier worklist attention, while requiring full-image review and clinical judgment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
DICOM non-contrast cervical-spine CT studies including at least five visible cervical vertebrae; the device filters and processes received series and transmits results to a worklist application.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Active positive or negative notification for suspected acute cervical-spine fracture, worklist prioritization, and a compressed grayscale unannotated preview labeled not for diagnostic use; result files can be transferred to a PACS or workstation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
The device is not designed to detect vertebral compression fractures. Previews are informational and not diagnostic, the original image is unchanged, and notified clinicians must review full images under standard of care. The indication is for the cervical-spine CT scope and acquisition requirements described above.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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.

FDA submission
K240942
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Cervical spine; acute cervical-spine fractures including non-displaced lines and displaced fragments
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-09-12
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
CINA-CSpine can integrate with the CINA Platform or another medical image communications device using DICOM, CT or other DICOM nodes, worklist, and PACS/workstation output in a hospital radiology department. Specific local interfaces and deployment configuration are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
On-premise
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

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 CINA-CSpine; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission ยท checked 2026-09-08
Source

Evidence

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 retrospective multicenter, multinational, blinded standalone testing used 328 anonymized cases, including 155 positive and 173 negative cases, with ground truth by consensus of three U.S.-board-certified expert radiologists. Sensitivity was 90.3% (95% CI 84.5%-94.5%) and specificity was 91.9% (95% CI 86.8%-95.5%). Mean time to notification for all cases was 2.9 minutes (95% CI 2.7-3.0; median 2.6; range 1.0-6.8); for 140 true-positive cases, mean time was 2.8 minutes (95% CI 2.6-3.0).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
90.3% (95% CI: 84.5%, 94.5%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

Reported specificity
91.9% (95% CI: 86.8%, 95.5%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

CINA-CSpine regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K240942
  • Samplen=328
  • IndependenceIndependence not established

K240942

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

Source

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

No public price or quote for the exact K240942 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

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 K240942. 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.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

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

  1. FDA K240942: CINA-CSpine

    U.S. Food and Drug Administration - Published 2024-09-12 - Accessed 2026-09-08

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. CINA-CSpine model card (K240942)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, output, reportedSensitivity, reportedSpecificity, evidenceSummary, anatomy, evidenceStudies

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K240942

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K240942 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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