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The Competitor Deuce femoral components are intended to be used for those patients whereby conditions exist that can not be solely addressed by a device that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee.

Indications include:

• Post-traumatic arthritis;
• Degenerative arthritis; and
• Failed osteotomies, hemiarthroplasties; and unicompartmental replacement

These indications will be used for the Competitor Deuce femoral components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.

The Competitor Deuce femoral components are single use only and are intended for implantation only with bone cement.

The components are used to replace the medial condyle and patellofemoral regions of a femoral knee joint. The Competitor Deuce femoral components will initially be available in both cobalt chrome and Oxinium. The overall design of the Competitor Deuce femoral components is based upon the existing Hybrid Knee femoral components and Competitor Duo femoral components subject of K042896 and K052265, respectively.

The provided document is a 510(k) summary for the Smith & Nephew Competitor Deuce Femoral Components. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth types) that would be typically associated with proving a device meets acceptance criteria in the context of an AI/software-as-a-medical-device (SaMD) study.

Instead, this document focuses on demonstrating substantial equivalence for a physical implantable device (a knee prosthesis component), primarily through mechanical and clinical data review, and comparison to predicate devices. It states: "A review of the mechanical and clinical data indicated that the Competitor Deuce femoral components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure."

Therefore, I cannot populate the requested table and answer the questions related to acceptance criteria and study details for an AI/SaMD device, as this information is not present in the provided text.

Here's a breakdown of what is available and why the requested information isn't:

Information Available:

• Device Name: Competitor Deuce Femoral Components
• Manufacturer: Smith & Nephew, Inc. Orthopaedic Division
• Device Description: Components used to replace the medial condyle and patellofemoral regions of a femoral knee joint. Available in cobalt chrome and Oxinium. Design based on existing Hybrid Knee femoral components and Competitor Duo femoral components.
• Intended Use/Indications: For patients with conditions that cannot be solely addressed by single-compartment devices, including post-traumatic arthritis, degenerative arthritis, and failed osteotomies, hemiarthroplasties, and unicompartmental replacements, affecting the medial condyle and patellofemoral regions. Single-use only, for implantation with bone cement.
• Classification: Class II, under 21 CFR 888.3560 (Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis).
• Substantial Equivalence: Claimed to be substantially equivalent to Smith & Nephew Hybrid Knee Femoral (K042896) and Competitor Duo Knee Femoral Component (K052265).
• Proof of Equivalence: A review of "mechanical and clinical data indicated that the Competitor Deuce femoral components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure."

Why the Requested Information (for AI/SaMD) is Not Applicable/Present:

The request asks for details typically found in validation studies for AI/Machine Learning algorithms or SaMDs. These studies involve quantifying performance metrics (e.g., sensitivity, specificity, AUC) against a ground truth established by experts, using specific datasets, and statistically proving performance against predefined acceptance criteria.

This document describes a physical medical device (a knee implant component). The "study" mentioned is a "review of mechanical and clinical data" to establish substantial equivalence based on existing predicate devices. This type of submission relies on:

• Design Similarity: How the new device is similar to predicate devices.
• Material Equivalence: Using materials known to be safe and effective.
• Biocompatibility Testing: (Though not explicitly detailed here, standard for implants).
• Mechanical Testing: Bench testing to demonstrate the device can withstand expected in vivo forces (e.g., fatigue testing, static strength testing). This is what the phrase "capable of withstanding expected in vivo loading without failure" refers to.
• Clinical Data Review: Often refers to reviewing literature, existing clinical experience with similar devices, or non-clinical data supporting the safety and effectiveness.

Since this is not an AI/SaMD, the concepts of "test set," "training set," "ground truth experts," "adjudication," "MRMC studies," or "standalone algorithm performance" are not relevant or discussed in this 510(k) summary.

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