LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K982267
    Device Name
    DPX-RX BONE DENSITOMETER
    Manufacturer
    LUNAR CORP.
    Date Cleared
    1998-08-18

    (50 days)

    Product Code
    KGI
    Regulation Number
    892.1170
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K904980,K945526
    Predicate For
    K030962,K052581,K072439,K180782
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DPX-RX Bone Densitometer provides an estimate of BMD at the lumbar Spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician. The use of the DPX-RX Bone Densitometer is restricted to prescription use only.

    Device Description

    The DPX-RX Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2) of the lumbar spine and the proximal femur.

    AI/ML Overview
    1. Table of Acceptance Criteria and Reported Device Performance:
    Acceptance CriteriaReported Device Performance
    Correlation with DPX-Lr > 0.98
    Average BMD ValuesVery similar to DPX-L in 50 subjects in vivo
    Average Short-Term Precision (%CV) In Vitro< 0.5%
    Short-Term %CV In VivoApproximately 1.0% for lumbar spine and proximal femur BMD

    1. Sample Size for Test Set and Data Provenance:

      • Sample Size: 50 subjects in vivo.
      • Data Provenance: Not explicitly stated, but based on the contact information (Madison, WI, USA) and the nature of medical device submissions to the FDA, it is highly likely that the data was collected in the USA.
      • Retrospective or Prospective: Not explicitly stated. Given that it's a submission for a new device claiming substantial equivalence, it's generally prospective for the new device testing itself, but could involve retrospective analysis of existing DPX-L data for comparison.

    2. Number of Experts and Qualifications: Not applicable. The study is a technical comparison of device measurements, not a diagnostic accuracy study requiring expert human interpretation for ground truth.

    3. Adjudication Method: Not applicable, as there's no human interpretation being adjudicated.

    4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC study was not done. The study compares the performance of the new device to a predicate device, not human readers with and without AI assistance.

    5. Standalone Performance: Yes, the study describes the standalone performance of the DPX-RX Bone Densitometer in terms of its BMD estimation, correlation with a predicate device, and precision.

    6. Type of Ground Truth Used:
      The "ground truth" here is the measurement obtained from the predicate device, the LUNAR DPX-L, and established precision metrics (e.g., %CV) from previously validated methods. It's a comparison against an existing gold standard device, rather than a biological "ground truth" like pathology.

    7. Sample Size for Training Set: Not applicable. This document describes a performance evaluation of a device, not the development of an AI algorithm with a training set.

    8. How Ground Truth for Training Set was Established: Not applicable.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1