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The general indications associated with the use of the Precedent Revision Hip System without HA in total hip arthroplasty include:

• Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (UD), e.g., rheumatoid arthritis.
• Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
• Revision of previously failed arthroplasty.
  The Precedent Revision Hip System without HA is intended only for use without bone cement.

The Precedent Revision Hip System is manufactured from either wrought or forged titanium alloy. The Precedent Revision Hip System features a threaded Sulzer 12/14 configured neck trunnion for attachment to Sulzer Orthopedics' currently marketed femoral heads, including Biolox and Zirconia heads, employing a Sulzer 12/14 configured bore. The Precedent Revision Hip System is available in both a collared and collarless design to address surgeon preference. The entire length of the Precedent Revision Hip System, except the neck region and the distal tip, is roughened via the process of grit blasting. The distal portion of the Precedent Revision Hip System employs flutes which cut into the distal cortices of the prepared femoral canal, thereby providing rotational stability to the hip stem. In addition, the Precedent Revision Hip System employs a coronal slot which potentially reduces bending stiffness of the distal stem and thigh pain. The distal tip of the Precedent Revision Hip System is polished to a machined finish to provide ease of insertion during surgery.

This document is a 510(k) summary for the Precedent Revision Hip System, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study. Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or stated based on the document's content:

1. Table of acceptance criteria and reported device performance:

This document does not specify quantitative acceptance criteria or report specific performance metrics from a dedicated study. The focus is on demonstrating "substantial equivalence" to existing legally marketed devices, implying that its performance is considered acceptable if it is similar to those predicate devices.

2. Sample size used for the test set and the data provenance:

No test set or associated data provenance is mentioned as this is a 510(k) for substantial equivalence, not a performance study as typically understood for new algorithms or AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method for the test set:

Not applicable.

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 is a hip implant, not an AI-assisted diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a hip implant, not an algorithm.

7. The type of ground truth used:

Not applicable. The "ground truth" here is the long-standing clinical experience and performance of the predicate hip systems, which the Precedent Revision Hip System is attempting to be substantially equivalent to.

8. The sample size for the training set:

Not applicable. There is no mention of a training set as this is not an AI/algorithm development.

9. How the ground truth for the training set was established:

Not applicable.

Summary of what the document does provide:

• Device: Precedent Revision Hip System, a femoral hip prosthesis for revision total hip arthroplasty.
• Purpose of filing: 510(k) to demonstrate substantial equivalence to predicate devices.
• Predicate Devices:
  • Sentry Femoral Component: Howmedica Inc.
  • S-ROM® Femoral Prosthesis: Joint Medical Product Corporation.
  • Stability Hip Stem: Depuy Inc.
  • Wagner Revision Stem: Protek Inc.
• Indications for Use: Primarily for femoral bone deficiencies associated with failure of primary total or hemi-hip arthroplasties, and for cementless application in total hip arthroplasty for conditions like non-inflammatory degenerative joint disease, inflammatory joint disease, and revision of previously failed arthroplasty.
• Regulatory Conclusion: The FDA determined the device is substantially equivalent to marketed devices prior to May 28, 1976. This allows marketing subject to general controls provisions of the Act.

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