|Approval Order Statement |
Approval for the addition of two new probes for use on two additional skeletal sites, the proximal third phalanx and the fifth metatarsal. The device, as modified, is indicated as follows: "a noninvasive device that is designed for the quantitative measurement of the signal velocity of ultrasonic waves ("speed of sound" or "sos" in m/sec) propagating at multiple skeletal sites (i. E. , the distal one-third of the radius, the proximal third phalanx, and the fifth metatarsal). Sos provides an estimate of skeletal fragility. The output is also expressed as a t-score and a z-score, and can be used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and, ultimately , in the determination of fracture risk. Multiple skeletal site testing provides clinicians with alternatives if one site is not accessible and with additional skeletal information (i. E. , from bones with different combinations of cortical and cancellous material and from weight bearing and non-weight bearing sites) that assists in diagnosing osteoporosis and risk fracture. The sos measurement by omnisense has a precision error low enough in comparison with the expected annual change in a patient's measurement to make it suitable for monitoring bone changes which occur in the early years following menopause (i. E. , age range approximately 50-65 years). ".