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1. When used as a hemi-hip replacement system, it is intended for osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal involvement of the corresponding acetabulum, femoral head or neck fractures, aseptic necrosis of the femoral head, previous failed hip arthroplasty where there is evidence of sufficient bone quality to adequately set the implant.
2. When used as a total hip replacement system, it is intended for osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal involvement of the corresponding acetabulum, femoral head or neck fractures, aseptic necrosis of the femoral head, previous failed hip arthroplasty where there is evidence of sufficient bone quality to adequately set the implant.
3. In addition, the SIERRA™ hip stem is intended for cases where alternative modes of trealment appear less preferable and the associated risks of a total hip replacement are thought to be acceptable. It is intended for severely disabled joints, which could result from arthritis or late stages of avascular necrosis and revisions of unsuccessful acetabular cup arthroplasty and/or femoral procedure.

The SIERRA™ Femoral Hip Stem is a sterile component used to help restore patient range of motion and aid in the treatment of other deformities as listed in the Indications for Use. The SIERRA™ Femoral Hip Stem has a tapered distal stem design and is available in a variety of options including cemented, porous coated or porous coated with hydroxylapatite (HA) coating. They are also available with standard or high offset necks, as well as collared and non-collared designs. This submission seeks clearance for the SIERRA™ Femoral Hip Stem, which is a line extension to the NexFlex™ Total Hip System. The SIERRA™ Femoral Hip Stem is manufactured from titanium alloy (Ti 6Al-4V, ASTM F136) or cobalt chrome (CoCrMo, ASTM F75). Cobalt chrome stems are intended for cemented use. The porous coated and HA/porous coated stems are intended for uncemented use.

The provided text describes the Sierra Femoral Hip Stem, a medical device, and its 510(k) clearance. However, it does not contain information about acceptance criteria, device performance, or a study that evaluates the device against such criteria.

The document is a 510(k) summary and an FDA clearance letter. These documents typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the way a clinical trial or a validation study for a new AI/software device would.

Specifically, the "Performance Data" section (VIII) only states: "Mechanical and dynamic testing of the SIERRA™ Femoral Hip Stem was performed." It does not provide any results, acceptance criteria, or details of these tests.

Therefore, I cannot answer the questions based on the provided text. The requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not present in this document.

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