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The GE Lunar DPX and Prodigy Series DEXA Bone Densitometers with Mobile Kit provides a measurement 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.

The GE Lunar DPX and Prodigy Series DEXA Bone Densitometers with Mobile Kit is a full-featured general purpose x-ray bone densitometer system. It consists of a scan table that provides x-ray source generation, x-ray detection and processing. The user interface includes a computer workstation. This modification will provide users the option of mounting the bone densitometer system into a vehicle through the use of a mechanical hardware mobile kit used during the installation of the scanner and by the Operator during transport.

The provided text describes a 510(k) premarket notification for a medical device and thus does not contain information on dedicated "acceptance criteria" and a "study" to prove the device met those criteria, as one might find in a clinical trial or performance study report. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the information provided, framed to address your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria with numerical targets are provided in the document. The performance is assessed through "in vitro precision and accuracy values" which were within "design specifications" (generic statement).

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

• Sample Size: Not applicable. The document states that "No clinical tests were required to establish safety or effectiveness." The testing mentioned was "in vitro precision and accuracy values ... computed through a series of tests on phantoms." The sample size (number of phantoms or tests conducted) is not specified.
• Data Provenance: Not applicable, as no clinical human data was used for effectiveness testing. The "in vitro" tests were performed by the manufacturer, within the US (GE Medical Systems Lunar, Madison, WI).

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

Not applicable. The in vitro tests on phantoms do not involve human expert adjudication for ground truth.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method was used given the nature of the in vitro phantom testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

Not applicable. This device is a bone densitometer, not an AI-assisted diagnostic tool, and no MRMC study was performed or required.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device itself is the "standalone" component in the context of phantom testing, but this is not an AI algorithm assessment. The document clarifies that the device includes a "computer workstation" for processing, but this is inherent to DEXA technology, not an AI application subject to standalone algorithm evaluation in the modern sense.

7. The Type of Ground Truth Used

For the in vitro precision and accuracy tests, the "ground truth" would have been established by the known physical properties of the phantoms used and the expected output values for those phantoms, based on standard metrology. This is an objective, physical ground truth.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense. The "design specifications" would have been developed through engineering and physics principles, not data-driven training.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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