|Approval Order Statement |
The device is indicated as follows: the achilles+ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called stiffness index. The stiffnes index indicateds risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (bmd) as measured by x-ray absorptiometry at teh spine or hip. Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorpiometry. Either the stiffness index t-score or x-ray absorptiometry t-score can be utilized by a physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment. The stiffness index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for moniotirng bone changes.