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The TCP-coated Porocoat AML® Fomoral Hip Prosthesis, with an appropriate Co-Cr-Mo alloy metal femoral ball, is intended to be used as the femoral component in total hip replacement. This femoral hip prosthesis is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.

This prosthesis may be used where x-ray evidence of sufficient sound bone to seat the femoral component exists. The prosthesis may be used for total hip replacement in the following indications, as appropriate:

• A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or theumatoid arthritis.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failed previous surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.
• Certain cases of ankylosis.

The TCP-coated Porocoat® AML® Femoral Hip Prosthesis is a % porous coated, straightstemmed, collared prosthesis with a thin coating of tricalcium phosphate sprayed onto approximately ½ of the porous coating of the implant and is designed to be used as the femoral component in total hip replacement without cement.

The provided text is a 510(k) premarket notification summary for a medical device, the TCP-coated Porocoat® AML® Femoral Hip Prosthesis. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through an AI/algorithm-based evaluation.

Instead, this document focuses on demonstrating substantial equivalence to an existing legally marketed device (DePuy Inc. AML® 5/8 Porocoat® Femoral Implant). Substantial equivalence means the new device is as safe and effective as a legally marketed predicate device.

Therefore, I cannot provide the requested information because the document describes a regulatory submission based on substantial equivalence, not a study evaluating acceptance criteria for an AI/algorithm.

Here's why the requested information cannot be extracted from the provided text:

• No AI/Algorithm: The device described is a physical hip prosthesis, not an AI or algorithm-based medical device.
• No "Acceptance Criteria" in the AI/Software Sense: The concept of "acceptance criteria" for performance metrics like sensitivity, specificity, or F1-score, as typically used for AI/software, is not applicable here. The "acceptance" in this context refers to regulatory approval based on demonstrating equivalence.
• No "Study" as such for AI Performance: The "clinical results" mentioned are used to establish comparability to the predicate device, not to measure an AI's performance against defined criteria.
• No Test/Training Sets, Ground Truth, or Experts for AI Evaluation: These concepts are entirely irrelevant to a 510(k) submission for a physical implant.

The document states:

• Basis of Substantial Equivalence: "The TCP-coated Porocoat® AML® Femoral Hip Prosthesis and the DePuy Inc. AML® % Porocoat® Femoral Implant are both intended for cementless use as the femoral component in total hip replacement. The devices are identical except for the thin coating of TCP plasma sprayed onto approximately ½ of the proximal porous coating.Clinical results show that the TCPcoated Porocoat® AML® Femoral Hip Prosthesis is comparable to the DePuy Inc. AML® % Porocoat® Femoral Implant."

This indicates that the key "test" was to show that adding the TCP coating did not negatively impact its performance compared to the predicate device, thereby maintaining substantial equivalence. The FDA letter reiterates this, stating: "The data presented support equivalence with no additional claims over a conventional porous-coated uncemented hip prosthesis (i.e., biological fixation, only)."

In summary, your request refers to a type of evaluation (AI algorithm performance) that is not relevant to the provided text about a hip prosthesis.

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