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The indications for the Corin Metalix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include:

• · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• · Rheumatoid arthritis
• · Correction of functional deformity
• · Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
• · Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
  The Corin Metafix Hip Stem is intended for cementless, single use only.

The Metafix Hip is a tapered stem manufactured from titanium (Ti6Al4V) with a layer of hydroxyapatite (HA) Coating applied. The Metafix™ Hip is available in a 135° standard offset (collared and collarless), 135° lateralized high offset (collarless), a 125° standard offset (collared and collarless), a 125° short neck (collared) and a 135° short neck (collared). The device is intended to be used with 12/14 modular taper heads.

This document is a 510(k) premarket notification for a medical device called the Corin Metafix Hip Stem. It's an FDA submission, not a study report. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance.

The document discusses the device's intended use, indications, and claims of substantial equivalence to previously marketed predicate devices. It mentions that non-clinical mechanical fatigue testing and range of motion analysis were performed, but no clinical testing was deemed necessary to establish substantial equivalence.

Here's a breakdown of why this document cannot provide the requested information:

• Acceptance Criteria & Reported Performance: These are typically quantitative metrics set for a medical device's performance, often established in clinical trials or specific engineering tests. This document doesn't provide such a table.
• Sample Size (Test Set) & Data Provenance: This refers to the number of patients or samples used in a study to evaluate the device's performance. Since no clinical study was conducted for this submission, this information is not present.
• Number of Experts & Qualifications: This is relevant for studies where expert opinion is used to establish ground truth or evaluate outcomes. Not applicable here.
• Adjudication Method: Also relevant for studies involving human interpretation of data. Not applicable here.
• MRMC Comparative Effectiveness Study: This is a specific type of clinical study comparing human reader performance with and without AI. The device described, a hip stem, is a physical implant, not an AI or imaging device, so this type of study is irrelevant.
• Standalone Performance (Algorithm only): This refers to the performance of an AI algorithm without human involvement. Not applicable to a physical hip stem.
• Type of Ground Truth: This refers to the definitive determination of a condition or outcome in a study. Since no clinical study is presented, no ground truth is established in this document.
• Sample Size (Training Set) & Ground Truth for Training Set: This is relevant for AI/machine learning models where data is used to 'train' the algorithm. Not applicable to a physical hip stem.

In summary, this document is a regulatory submission for a hip implant, not a clinical or AI performance study. It does not contain the detailed information you requested about acceptance criteria and study data.

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