(56 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation with predicate device (LUNAR DPX) for BMD estimations. | r > 0.98 with the DPX. |
| Similarity of average BMD, lean, and fat tissue mass values compared to predicate device. | Very similar to the results obtained on a DPX in 46 subjects. |
| Short-term precision (%CV) in vivo for total body BMD. |
§ 892.1170 Bone densitometer.
(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.