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The subject hip stem is a single-use device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a 5° 40' BG taper.

Indications:

• Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
• Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• Revision procedures where other treatments or devices have failed.

The existing Accolade™ TMZF® HA Hip System features femoral stems in neutral, press-fit versions consisting of a variety of lengths and two neck angles, 132° and 127°. The subject Accolade™ TMZF® HA 132° Size 0 Hip Stem is an addition to the existing hip stems. It features a 132° neck angle and will be offered in an additional size (size 0). The Accolade™ TMZF® HA Size 0 Hip Stem is intended for smaller size patient populations. The subject hip stem, like the predicate hip stems, is manufactured using TMZF® alloy and is also coated with a CP Titanium plasma spray coating and PureFix™ HA.

The provided document describes a 510(k) premarket notification for a hip stem, a medical device, not an AI/ML powered device. Therefore, the information requested in your prompt (e.g., acceptance criteria for device performance, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test/training set, training set sample size) are not applicable or extractable from this document.

The document mainly focuses on:

• Device Description and Technological Comparison: It introduces the Accolade™ TMZF® HA 132° Size 0 Hip Stem as an extension to an existing hip system, noting its material (TMZF® alloy, CP Titanium plasma spray, PureFix™ HA) and intended patient population (smaller size).
• Intended Use and Indications: Specifies its use in total hip replacement, reconstruction of the femoral joint, and its compatibility with other Howmedica Osteonics components. It lists indications such as cementless primary hip surgery for various degenerative joint diseases, treatment of certain fractures, and revision procedures.
• Testing Summary: It briefly states, "Testing was employed to evaluate the Accolade™ TMZF® Size 0 Hip Stem component. Analysis indicates that this hip stem component successfully maintains the proper strength requirements." This is a very high-level statement and does not provide specific acceptance criteria or details of the study.
• Regulatory Information: It includes the proprietary name, common name, classification, regulatory class, product code, and predicate device information, along with the FDA's substantial equivalence determination.

In summary, this document is a regulatory approval notice for a conventional medical device and does not contain the detailed performance study information relevant to AI/ML powered devices as per your request.

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