(290 days)
The BUECHEL-PAPPAS™ Modular Salvage Shoulder Replacement System is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis, rheumatiod arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis; for use in the absence of a functionally sufficient rotator cuff as well as where the proximal humerus is insufficient to support a standard angled humeral prosthesis. Biocoat® porous coated components are intended for cemented use.
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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth.
The document is a 510(k) clearance letter from the FDA for the "Buechel-Pappas Modular Salvage Shoulder Replacement System," and an "Indications For Use" statement for the device. It indicates that the device has been determined to be substantially equivalent to devices marketed prior to May 28, 1976. This type of regulatory document does not typically contain the detailed technical study information you are requesting.
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