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1. The ProClass Press Fit Hip Stem is a single use, cementless device used for reconstruction of the articulating surface of the femur portion of the hip that is severely disabled and/or very painful resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or fracture of the femoral head provided there is sufficient sound bone to seat the prosthesis.
2. The stem can be used for primary hip implant or for hip revision of a failed implant.
3. The stem can be used for congenital defects that will allow adequate function of the system.

ProClass Press Fit Hip Stem is a single use, cementless device.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance tables, study designs, sample sizes (for test or training sets), data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

The document is an FDA 510(k) clearance letter for the "ProClass Press Fit Hip Stem." It primarily states that the device is substantially equivalent to legally marketed predicate devices and lists its intended "Indications For Use." It does not include data from a study that would demonstrate the device meets specific acceptance criteria.

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