(132 days)
The Hologic Whole Body DXA Reference Database software used on Hologic QDR bone densitometers measures the regional and whole body bone mineral density, lean and fat tissue mass and calculates derivative values of bone mineral content, area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional and total soft tissue mass ratios, % fat, regional % fat, total body % fat, android % fat, gynoid % fat, android/gynoid ratio, and body mass index. The values can be displayed in user-defined statistical formats and trends with color image mapping, and compared to reference populations at the sole discretion of the health care professional.
These body composition values are useful to health care professionals in their management of diseases and conditions where the disease or conditions itself, or its treatment, can affect the relative amounts of fat and lean tissue. The Hologic Whole Body DXA Reference Database software does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases and conditions for which body composition values are useful include chronic renal failure, anorexia nervosa, obesity, AIDS/HIV, and cystic fibrosis. DXA body composition is a useful alternative to hydrostatic weighting and skin fold measurements.
The Hologic Whole Body DXA Reference Database software used on Hologic QDR bone densitometers measures the regional and whole body bone mineral density, lean and fat tissue mass and calculates derivative values of bone mineral content, area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional and total soft tissue mass ratios, % fat, regional % fat, total body % fat, android % fat, gynoid % fat, android/gynoid ratio, and body mass index. The values can be displayed in user-defined statistical formats and trends with color image mapping, and compared to reference populations at the sole discretion of the health care professional.
The provided text is a 510(k) summary for the Hologic Whole Body DXA Reference Database. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.
Here's a breakdown of what is in the document, and what is missing based on your request:
What is present in the document:
- Device Identification: Hologic Whole Body DXA Reference Database.
- Intended Use: Measures regional and whole body bone mineral density, lean and fat tissue mass, and calculates derivative values for comparison to reference populations. It's for healthcare professionals to manage diseases/conditions affecting fat and lean tissue, not for diagnosis or treatment effectiveness quantification.
- Classification: Class II, Bone Densitometer, Product Code KGI.
- Predicate Device: Body Composition Software Option for GE Lunar DEXA Bone Densitometers (K071570).
- Conclusion of Substantial Equivalence: The Hologic Whole Body DXA Reference Database does not change algorithms/measured values from previously cleared software (APEX 2.0 Software K072847), fundamental scientific technology, or raise new safety/efficacy concerns. It is substantially equivalent to the predicate device.
What is NOT present in the document, and therefore cannot be reported:
- A table of acceptance criteria and the reported device performance: This document explicitly states that the device "does not change any of the algorithms or measured values" from a previously cleared software (APEX 2.0 Software, K072847). This 510(k) is based on demonstrating substantial equivalence because no changes were made to the core algorithms, rather than presenting new performance data against specific acceptance criteria for a new or modified device.
- Sample size used for the test set and the data provenance: No new test set data is provided, as the submission relies on the unchanged algorithms from a previously cleared device.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no new test set is presented.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No MRMC study is mentioned. The submission is based on the system's underlying algorithms being unchanged and previously cleared.
- Standalone (i.e., algorithm only without human-in-the-loop performance) study: No new standalone study is performed or reported in this document for the reasons stated above.
- The type of ground truth used: Not applicable, as no new study requiring ground truth establishment is described.
- The sample size for the training set: Not applicable, as this submission is not about training a new algorithm or presenting new performance metrics.
- How the ground truth for the training set was established: Not applicable.
In summary: The provided document is a 510(k) summary demonstrating substantial equivalence based on the lack of change to previously cleared software algorithms and measured values, rather than presenting new performance data against specific acceptance criteria for the "Hologic Whole Body DXA Reference Database" as a new or modified device with altered performance. Therefore, the information requested regarding acceptance criteria and performance studies is not contained within this particular submission.
§ 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.