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The Total Body Software is used with the Prodigy bone densitometer system. This software provides an estimate of BMD, fat and lean tissue mass. The BMD value can then be compared to a reference population at the sole discretion of the physician.

The Total Body Software for the Prodigy bone densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2), lean and fat tissue mass of the total body.

Acceptance Criteria and Study for Prodigy Total Body Software:

This device is a bone densitometer software, and its primary function is to provide estimations of Bone Mineral Density (BMD), lean tissue mass, and fat tissue mass. The acceptance criteria and supporting study focus on the correlation and precision of these measurements compared to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 46 subjects.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) summary, it is generally assumed that these studies are typically prospective clinical performance studies conducted in a controlled environment.

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

• This type of device (bone densitometer software) uses physical measurements rather than subjective interpretation by experts for its primary output (BMD, lean/fat tissue mass). Therefore, the concept of "experts establishing ground truth" in the diagnostic image interpretation sense does not directly apply here.
• The "ground truth" for the test set is established by the measurements obtained from the predicate device (LUNAR DPX Total Body Software), which is itself a validated bone densitometer. The comparison is between the new device's readings and the predicate device's readings. The predicate device's performance would have been established through prior clinical validation.

4. Adjudication Method for the Test Set:

• Not applicable. The study involves direct comparison of quantitative measurements (BMD, mass) between two devices on the same subjects, not expert adjudication of subjective interpretations.

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

• No, an MRMC comparative effectiveness study was not done. This device is an automated measurement system and does not involve human readers interpreting images. The study focuses on the agreement between the device's measurements and those of a predicate device.

6. Standalone Performance Study (Algorithm Only):

• Yes, the study described is a standalone performance study in the sense that it evaluates the algorithm's (software's) output by comparing its quantitative measurements directly against those of a predicate device. There is no human-in-the-loop performance evaluated in this summary.

7. Type of Ground Truth Used:

• Instrumental/Comparative Ground Truth: The ground truth is established by the measurements obtained from a legally marketed and presumably validated predicate device, the LUNAR DPX Total Body Software. The new device's measurements are compared to the predicate device's measurements.

8. Sample Size for the Training Set:

• The document does not explicitly state the sample size for a training set. For a bone densitometer software, development often involves extensive internal testing and calibration using phantoms and potentially a large retrospective dataset for algorithm refinement, but this information is not typically included in a 510(k) summary as a distinct "training set" size. The 46 subjects mentioned are for the validation/test set.

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

• As the training set sample size and its specific details are not provided, the method for establishing ground truth for a hypothetical or implied training set is also not detailed. However, generally for such devices, ground truth for algorithm development and calibration would involve:
  • Phantom Studies: Using known, precisely measured physical phantoms with established BMD and composition.
  • Comparison to Reference Methods: Potentially comparative studies against DEXA gold standards or other validated technologies if available during early development.
  • Clinical Data with Predicate Device Correlation: Using data where the predicate device's measurements serve as the reference.

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