(21 days)
- Hip arthritis caused by rheumatoid disease, noninflammatory degenerative joint disease (osteoarthritis) or traumatic arthritis from biologic or mechanical trauma to the hip.
- Correction of functional deformity.
- Treatment of nonunions, femoral neck and trochanteric fractures of the proximal femur.
- Difficult clinical management problems involving persistent pain and physical impairment where conventional arthrodesis is not likely to achieve satisfactory results.
Not Found
This document is a 510(k) clearance letter from the FDA for the 'Provident Hip System'. It confirms that the device is substantially equivalent to previously marketed devices and outlines the indications for use.
Based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets acceptance criteria.
The document is a regulatory approval, not a scientific study report. It mentions the "indications for use" for which the device was cleared, but it does not detail any performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to an acceptance criteria assessment.
Therefore, I cannot provide the requested information.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.