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The Exactech AuRA Calcar Replacement Femoral Stem is indicated for use in skeletally mature patients in whom the calcar region is missing due to a failed previous total hip replacement as a result of osteoarthritis, osteonecrosis , rheumatoid arthritis or congenital hip dysplasia. It is also potentially indicated for use in post-traumatic degenerative problems. FOR CEMENTED USE ONLY

The collar of the calcar replacement stem differentiates itself from all other cemented femoral components in that it provides a horizontal and vertical collar type platform for the best load transfer in a compromised femoral situation. A cemented primary or long stem device typically has a collar designed at some angle to the femoral centerline whereby a bone loading platform can be established at the optimum resection location. In many instances, this ideal position has been compromised and an implant surface that is horizontally perpendicular to and vertically parallel to the femoral centerline is preferred for optimal axial load transfer to the bone and appropriate trochanteric fixation can be achieved. The surface finish is dominated by an overall satin, glass bead blast everywhere except on the taper. A secondary grit blast is performed on portions of the proximal region of the implant. A complete instrumentation and trial system is available to assist in accurate implantation of the AuRATM Calcar Replacement Femoral Stem.

The provided text describes a medical device, the AuRA™ Hip System Calcar Replacement Femoral Stem, and its regulatory submission (K962002). However, it does not contain information regarding an acceptance criteria table, device performance data, or a study specifically designed to compare against acceptance criteria.

The document focuses on demonstrating substantial equivalence to pre-amendment devices and other legally marketed devices, primarily through:

• Device Description and Design Rationale: Highlighting features like material, surface finish, and collar design.
• Similarities/Dissimilarities to a Predicate Device (Howmedica hnr Hip System): Comparing material, design elements, and sizes.
• Material Specifications: Referring to ASTM standards for forged cobalt chrome.
• Mechanical Testing: Stating that forged cobalt chromium exhibits specific mechanical properties and that "fatigue testing results have been favorable for this type of device."
• Biocompatibility: Citing ASTM F799-95 for evaluation of biocompatibility and corrosion resistance.
• Sterilization: Describing the sterilization method (gamma irradiation) and adherence to AAMI guidelines.
• Utilization of Implantation, Indications, and Contraindications.

Therefore, I cannot fulfill your request for: "A table of acceptance criteria and the reported device performance," nor can I provide details about the specific study that proves the device meets those criteria, as this information is not present in the provided text.

The document's intent is to establish substantial equivalence based on material, design, and general mechanical properties, rather than present a study with specific performance metrics against defined acceptance criteria for a new, novel AI or diagnostic device.

To directly answer your specific numbered questions based on the lack of this information in the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided in the text.
2. Sample size used for the test set and the data provenance: Not applicable, as no such test set or study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such test set or study is described.
4. Adjudication method for the test set: Not applicable, as no such test set or study is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is about a hip implant, not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is about a hip implant, not an AI or diagnostic device.
7. The type of ground truth used: Not applicable, as no such test is described. The "ground truth" for a hip implant's equivalence relies on material properties, design comparison, and clinical history of similar devices.
8. The sample size for the training set: Not applicable, as no "training set" in the context of an AI/diagnostic algorithm is relevant to this device submission.
9. How the ground truth for the training set was established: Not applicable, as no "training set" or "ground truth" in the context of an AI/diagnostic algorithm is relevant to this device submission.

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