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The EXPERT-XL Hand and/or Forearm Acquisition and Analysis Software is an accessory software option for estimation of Bone Mineral Density BMD (in g/cm3) of the forearm and/or hand region provided for by the EXPERT-XL Bone Densitometer.

The EXPERT-XL Hand and/or Forearm Acquisition and Analysis Software is an accessory software option for estimation of Bone Mineral Density BMD (in g/cm3) of the forearm and/or hand region provided for by the EXPERT-XL Bone Densitometer.

The provided text does not contain detailed information about acceptance criteria, a comprehensive study design, or specific performance metrics as typically expected for medical device evaluations. The document is a 510(k) summary, which provides a high-level overview for regulatory clearance.

Based on the provided text, here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• Specific numerical thresholds for "highly correlated" (e.g., r > 0.95).
• Specific numerical thresholds for acceptable precision (e.g., CV < 2.5%).
• Specific numerical thresholds for acceptable radiation exposure in comparison to the predicate device or a safety limit.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size used for the test set. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

This information is not provided in the document. The study described relies on correlation with a predicate device, not on expert adjudication of diagnostic outcomes.

4. Adjudication Method:

This information is not applicable/not provided. The study focuses on correlation and precision of quantitative measurements (BMD), not on diagnostic interpretation requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not conducted or described. The device is for quantitative measurement (Bone Mineral Density) and is an "accessory software option" for an existing densitometer, not a diagnostic imaging interpretation tool that would typically involve human readers.

6. Standalone Performance:

Yes, a standalone performance assessment was conducted in terms of correlation with the predicate device and in-vivo precision. The device itself calculates BMD values without human intervention for the primary measurement.

7. Type of Ground Truth Used:

The "ground truth" for the device's performance relies on:

• Correlation with a predicate device (DPX series) results: The DPX series itself is the established standard for BMD measurement that has already received 510(k) clearance.
• In-vivo precision measurements: This establishes the repeatability of the device's own measurements.

8. Sample Size for the Training Set:

The document does not provide information on the sample size used for any potential training set. Given that this is an "accessory software option" for an established densitometer (EXPERT-XL), the machine learning or algorithm training aspects are not detailed. It's more likely that the software implements established densitometry algorithms rather than being a de novo AI model requiring extensive training data in the modern sense.

9. How the Ground Truth for the Training Set Was Established:

This information is not provided. If there was algorithm training involved, the document does not describe its methodology or how ground truth was established for that purpose.

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