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The P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component is indicated for use in total and partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from theumatoid arthritis, osteoarthritis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of a prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.

The P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component is indicated for use without bone cement (PMMA).

The P.F.C. 2 Total hip System Porous Coated Femoral Component in the smaller sizes is manufactured from titanium alloy (Ti-6A1-4V), the same material used to manufactured the P.F.C. 2 femoral components in the larger sizes. In addition to the sixteen sizes available under premarket notification #K935452, five additional sizes are available; three standard sizes (1/1, 2/2, and 3/3) and two additional sizes (2/1 and 3/2) to accommodate patient populations with proximal to distal incongruity.

This document is a 510(k) summary for a medical device (P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component). It does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of performance metrics for an AI/software device.

The questions you've asked are typically relevant to the validation of AI/ML-driven medical devices, especially those that provide diagnostic or prognostic information based on analyzing medical images or data. This document describes a physical orthopedic implant.

Therefore, I cannot extract the requested information from the provided text. The document focuses on:

• Device Identification: Name, classification, contact person.
• Substantial Equivalence: Comparing the new, smaller sizes of the device to previously cleared, larger sizes of the same device. This is a regulatory pathway for physical devices, not an AI performance evaluation.
• Indications for Use: What the device is intended to treat.
• Physical Description: Materials and sizes.

None of these sections discuss performance metrics like accuracy, sensitivity, specificity, AUC, or the methodology of an AI validation study (e.g., sample sizes, ground truth establishment, expert adjudication, MRMC studies).

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