(59 days)
QCT bone densitometry is indicated for patients with suspected loss of bone to identify QCT bone delistionied I is meetar of the highly responsive spinal trabecular bone is indicated for early detection of bone loss.
QCT is useful for measuring bone loss or gain with time for monitoring osteoporsis QCT Is useful for mousaning other collect to increased fracture risk by WHO criteria.
QCT Bone Densitometer (QCT 5000 and QCT 3000)
I am sorry, but the provided text from the FDA 510(k) letter and the Indications For Use document does not contain the detailed information necessary to fully answer your request regarding the acceptance criteria and the study that proves the device meets those criteria.
The documents indicate that the "QCT Bone Mineral Analysis Software" (K992246) and "QCT Bone Densitometer (QCT 5000 and QCT 3000)" were found substantially equivalent to legally marketed predicate devices. However, they do not include the specific performance data, acceptance criteria, study design details, or expert qualifications that your questions ask for.
To answer your questions, I would need access to the actual 510(k) submission summary or other detailed performance study reports for this device.
§ 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.