Radiology AI Directory

FDA-cleared profile

OsteoSight™ Hip (v1)

Naitive Technologies Ltd

Authorized purpose: Opportunistically analyzes standard AP hip or pelvis radiographs in patients aged 50 years and older and issues a report when the estimated femoral-neck BMD is below a preset threshold to prompt clinical bone-health assessment; absence of a report does not rule out low BMD.

MSK and bone
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: Opportunistically analyzes standard AP hip or pelvis radiographs in patients aged 50 years and older and issues a report when the estimated femoral-neck BMD is below a preset threshold to prompt clinical bone-health assessment; absence of a report does not rule out low BMD.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Opportunistically analyzes standard AP hip or pelvis radiographs in patients aged 50 years and older and issues a report when the estimated femoral-neck BMD is below a preset threshold to prompt clinical bone-health assessment; absence of a report does not rule out low BMD.

Evidence takeaway

Evidence from the reviewed source record: Study type: Stand-Alone Performance. Cases: 3082. Sites: 6. Reported sensitivity: 37% (95% CI: 34.9%, 39.1%). Reported specificity: 95.1% (95% CI: 93.6%, 96.3%)

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
Opportunistically analyzes standard AP hip or pelvis radiographs in patients aged 50 years and older and issues a report when the estimated femoral-neck BMD is below a preset threshold to prompt clinical bone-health assessment; absence of a report does not rule out low BMD.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06

Exact clinical-use normalization from the FDA packet; this text is also the locked corrections value.

Intended users
Radiologists and/or physician interpreters
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Intended-user text reported in the exact-submission ACR model card.

Care setting and population
Adult
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.

Workflow role
Triage or notification support
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Conservative normalization of explicit wording in an exact-submission source.

Required input
XRAY images or data. Inclusion criteria: Standard anteroposterior (AP) radiographs of the hip or pelvis in patients aged 50 years and older; DICOM images from imaging device, intermediate DICOM node, or PACS system
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Conservative normalization of explicit wording in an exact-submission source.

Output and human action
OsteoSight applies an AI-enabled algorithm pipeline to estimate bone mineral density (BMD) at the femoral neck. The algorithm presents a binary output to indicate whether the patient likely has low BMD at the femoral neck. If an estimated BMD is below the pre-specified threshold, OsteoSight generates a report (Results Report) indicating that the patient is at risk of having low BMD, which is delivered to the interpreting physician via the host integration platform. If the estimated BMD is above or equal to the pre-specified threshold, no report is generated.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Clinical output reported in the exact-submission ACR model card.

Limitations
A missing or above-threshold report does not rule out low BMD; clinicians should follow recommended screening and assessment regardless of the report, and the FDA packet does not establish current commercial hosting or support terms.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06

Exact-product limitations and clinician-review boundary from the FDA packet.

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
K251408
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • Public source
  • Exact FDA submission
  • Checked 2026-09-06

Imaging modality reported in the exact-submission ACR AI Central model card.

Anatomy
MSK
  • Public source
  • Exact FDA submission
  • Checked 2026-09-06

Anatomy normalized from explicit exact-submission ACR model-card wording.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-09-02
  • 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
The exact-submission ACR model card explicitly references DICOM and PACS in the described input, output, or workflow; exact interfaces, versions, and local compatibility require confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Interoperability terms explicitly reported in the exact-submission ACR model card; interface versions and local compatibility still require confirmation.

Deployment and data flow
Hybrid
  • 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 2026-08-13

FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

Family pre-operative workflow

Naitive describes OsteoSight as background X-ray analysis intended to provide an evidence-backed flag for orthopedic surgeons before surgery.

product family · checked 2026-09-06

Exact site workflow, hosting, and support terms require confirmation.

Source

Family input-quality handling

The peer-reviewed family study reports exclusion of unsuitable cases such as wrong body parts, metalwork, or unacceptable femur positioning before analysis.

product family · checked 2026-09-06

Product-family study; it does not establish exact K251408 commercial release behavior.

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
Study type: Stand-Alone Performance. Cases: 3082. Sites: 6. Reported sensitivity: 37% (95% CI: 34.9%, 39.1%). Reported specificity: 95.1% (95% CI: 93.6%, 96.3%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Structured study metadata from the exact-submission ACR model card; this is not an independent evidence synthesis.

Reported sensitivity
37% (95% CI: 34.9%, 39.1%)
  • 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
95.1% (95% CI: 93.6%, 96.3%)
  • 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.

Sensitivity

0.37 proportion

  • EndpointSensitivity for femoral-neck BMD below the preset threshold
  • PopulationIntended-use validation of standard AP hip or pelvis radiographs from adults aged 50 years and older across 6 sites
  • Tested versionOsteoSight Hip (v1); FDA submission K251408
Source

OsteoSight™ Hip (v1) regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K251408
  • Samplen=3082
  • Sites6
  • IndependenceIndependence not established

K251408

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

Source

Opportunistic assessment of osteoporosis using hip and pelvic X-rays with OsteoSight: validation of an AI-based tool in a US population

  • DesignPeer-reviewed diagnostic validation study
  • PopulationUS population with hip or pelvic X-rays compared with DXA; robustness and reproducibility were evaluated across demographic groups and scanner hardware
  • Scopeproduct family
  • Tested versionOsteoSight product family; exact commercial release not reported
  • IndependenceSponsor or vendor study

PMID:40263144 · PMCID:PMC12122585 · DOI:10.1007/s00198-025-07487-0

Authors include Naitive employees/shareholders; treat as vendor-sponsored family evidence, not independent exact-release performance. The abstract reports preprocessing exclusions for wrong body parts, metalwork, and unacceptable femur positioning.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-06

Official non-FDA product sources were reviewed for buyer and workflow context, but no exact-submission amount, currency, unit, term, or implementation fee was displayed. A vendor quote remains required.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

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.

Human reviewedStatus
2026-09-07Last searched
27Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

Stored exact-submission candidate metadata had zero PubMed and ClinicalTrials.gov identifiers; this metadata screening is not a full paper or registry-record review. 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, peer reviewed publication, 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. K251408 FDA decision source

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

    Scope: regulatoryIdentity, purpose, modality, anatomy

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. OsteoSight™ Hip (v1) model card (K251408)

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

    Scope: purpose, modality, intendedUsers, careSetting, output, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  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. FDA 510(k) decision material K251408: OsteoSight Hip

    U.S. Food and Drug Administration - Accessed 2026-09-06

    Scope: identity, clinical, evidence, implementation

  8. OsteoSight

    Naitive Technologies - Accessed 2026-09-06

    Scope: buyer_workflow, clinical, implementation

  9. Opportunistic assessment of osteoporosis using hip and pelvic X-rays with OsteoSight: validation of an AI-based tool in a US population

    Osteoporosis International / PMC - Accessed 2026-09-06

    Scope: family_evidence, clinical, implementation

Research history

  1. K251408 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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