(240 days)
The Automated Bone Mineral Density Software Module (ABMD) is a post-processing AI-powered software intended to measure bone mineral density (BMD) from existing CT scans by averaging Hounsfield units in the trabecular region of vertebral bones. ABMD is not intended to replace DXA or any other tests dedicated to BMD measurement. It is solely designed for measuring BMD in existing CT scans ordered for reasons other than BMD measurement. In summary, ABMD is an opportunistic AI-powered tool that enables: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans, and (3) assessment of bone density without a phantom as an independent measurement procedure.
The Automated Bone Mineral Density (ABMD) Software is a software module that estimates bone mineral density in the vertebral bones by averaging Hounsfield Units (HU) in the trabecular area. ABMD Software is a post-processing software that works on existing CT scans. ABMD Software measurements are to be reviewed by radiologists and should be used by healthcare providers in conjunction with clinical evaluation.
Here's a breakdown of the acceptance criteria and study information for the ABMD Software based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation with Manual QCT-based BMD Measurement | Strong correlation reported (`t = 0.97, p |
§ 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.