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Specific diagnostic indications for use of the APR Oversized Hip Stem include:

• patient conditions of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, and arthritis secondary to a variety of diseases and anomalies;
• avascular necrosis of the femoral head and/or non-union of femoral neck fractures;
• femoral fractures; and
• fracture dislocation of the hip.

The APR Oversized Hip Stem is an anatomic femoral component that is intended for prosthetic replacement of the proximal portion of the femur in a hip replacement. This device is manufactured from wrought Ti-6A1-4V alloy (ASTM F 136) and is available in both porous and nonporous versions for use in cemented or press-fit applications. The APR Oversized Hip Stem will be offered with the intent of augmenting IOI's anatomic product line by addressing the metaphyseal mismatch found in a significant portion of the patient population. While the currently marketed APR Hip Stem is a proportional design, the APR Oversized Hip Stem is designed for the Type A endosteal canal in which the diaphysis is disproportionately smaller than the metaphysis. By adding this "proximally upsized," or "oversized," version to the currently marketed product line, the surgeon can obtain good fit and fill of the medullary canal without sacrificing distal cortical bone in those patients which exhibit proximal/distal mismatch.

This document is a 510(k) summary for a medical device called the "APR® Oversized Hip Stem." It describes the device, its intended use, and claims substantial equivalence to other legally marketed devices based on theoretical calculations and fatigue loading conditions.

However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically expected for a diagnostic or AI-driven device. This document is for a physical orthopedic implant, not a diagnostic device that would have performance metrics like sensitivity, specificity, or AUC.

Therefore, most of the questions you've asked, which are relevant to evaluating diagnostic/AI devices, cannot be answered from the provided text.

Here's a breakdown based on what can be extracted, and where information is missing:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated as numerical performance metrics for a diagnostic device. The acceptance is based on "comparability" to legally marketed devices in terms of strength and design.
   • Reported Device Performance: "The strength of the APR Oversized Hip Stem was analyzed using theoretical calculations and fatigue loading conditions and shown to be comparable to other legally marketed devices." No specific numerical performance values (e.g., fatigue life cycles, ultimate strength numbers) are provided in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable. This is a physical implant, not a diagnostic algorithm. The "test set" would refer to the physical testing of the implant, but no details on sample size or provenance of "data" in that context are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. "Ground truth" in this context would refer to the mechanical properties established through engineering testing, not expert interpretation of medical data. No information on experts involved in establishing these mechanical properties is given.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This concept is for clinical or diagnostic studies.

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 for AI-assisted diagnostic devices.

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

   • Not applicable. This is for AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For a physical implant, the "ground truth" would be the actual mechanical properties of the material and design, determined through engineering tests (e.g., destructive testing, fatigue testing). The summary states "theoretical calculations and fatigue loading conditions," implying these engineering methods were used.

8. The sample size for the training set:

   • Not applicable. This refers to AI training.

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

   • Not applicable. This refers to AI training.

In summary, the provided document is a regulatory submission summary for a physical medical device (hip stem implant) aiming for 510(k) clearance by demonstrating substantial equivalence. The questions are largely tailored for diagnostic or AI-driven medical devices, which have different regulatory and validation requirements. The "study" mentioned is the "theoretical calculations and fatigue loading conditions" to demonstrate strength comparable to existing devices, which is sufficient for this type of submission.

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