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510(k) Data Aggregation
(21 days)
MODIFICATION TO PROVIDENT HIP SYSTEM
- 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.
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(49 days)
MODIFICATION TO PROVIDENT HIP SYSTEM
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