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The Lunar iDXA Bone Densitometer provides an estimate of bonc mineral density and fat and lean tissue mass. The values can then be compared to a reference population at the sole discretion of the physician.

The Lunar iDXA bone densitometer is a full featured general purpose x-ray bone densitometer system. It consists of a scan table that provides x-ray source generation, digital x-ray detection and processing. The user interface includes a computer workstation and a color monitor display. This modification will provide users with improved image resolution and ease of use with patients of larger size.

The GE Medical Systems Lunar iDXA Bone Densitometer is a full-featured general-purpose x-ray bone densitometer system that provides an estimate of bone mineral density and fat and lean tissue mass. The values can then be compared to a reference population at the sole discretion of the physician.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state quantitative acceptance criteria for the iDXA bone densitometer. However, it does state that the device's accuracy and precision were verified and met design specifications. The performance is assessed by comparison to a predicate device.

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

• Sample Size: A 40-person in vivo study was conducted.
• Data Provenance: The document does not specify the country of origin of the data. It was a prospective in vivo study performed to verify design specifications.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The study involved in vivo measurements for accuracy and precision verification, likely against internal phantom standards and potentially expert review of the derived measurements, but the document does not specify the use of "experts" for establishing ground truth in the context of diagnostic interpretation.

4. Adjudication Method for the Test Set:

Not applicable. The study focused on the technical performance (accuracy and precision) of the device rather than diagnostic adjudication by multiple readers.

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

No, an MRMC comparative effectiveness study was not explicitly described. The study focused on the device's technical specifications and substantial equivalence to a predicate device, not on the improvement of human readers with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

Yes, the study primarily describes the standalone technical performance of the device in terms of accuracy and precision. The device itself is an apparatus that provides measurements, rather than an AI algorithm requiring human interpretation. The "algorithm" here refers to the internal processing of the iDXA system to derive bone mineral density and tissue mass.

7. Type of Ground Truth Used:

• For accuracy and precision: The ground truth was established by in vitro tests on phantoms and confirmed by the in vivo study to verify that design specifications were met. The phantoms likely have known, established values for bone mineral density and tissue composition.
• For safety and effectiveness: The ground truth was established by applicable medical device safety standards and comparison to the predicate device (Prodigy bone densitometer: K915535, K982267, K983564, K000826, K001756, K001812, K011917, K023554).

8. Sample Size for the Training Set:

Not applicable. The device is a bone densitometer, not a machine learning algorithm that typically requires a separate training set. The "training" would refer to the engineering and calibration of the device.

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

Not applicable. As above, this is not a machine learning device with a distinct training set and associated ground truth establishment process. The device's design, calibration, and validation are part of its engineering development process.

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