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The Stryker Hip Arthroscopy Set, consisting of reusable instrumentation to access, illuminate and visualize the confines of the hip joint, is indicated for operative and diagnostic arthroscopic procedures of hip joint pathology including evaluation and the removal of loose bodies. Resection of soft, osseous and cartilaginous tissues is possible when used in conjunction with Stryker sterile disposable Rotary Hip Surgical Blades.

The Stryker Hip Arthroscopy Set is composed of reusable instruments including: extended length rigid telescopic arthroscopes and accessories with 30° and 70° oblique view angles, extended length manual surgical instruments made of surgical stainless steel. The instruments are maintained in a hardened plastic tray that accommodate repeat sterilization of the devices. The set is to be used in combination with various styles of Stryker disposable Hip Rotary Surgical Blades.

This document is a 510(k) premarket notification for the Stryker Hip Arthroscopy Set, seeking clearance from the FDA for commercial marketing. It does not include data from a study to prove the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or reader improvement.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This means that Stryker is asserting their device is as safe and effective as devices already on the market, not necessarily that it has met specific, novel performance benchmarks through a new study.

Therefore, many of the requested sections regarding acceptance criteria and study details cannot be answered from the provided text.

Here's an analysis of what can be extracted:

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

   • Acceptance Criteria: Not explicitly stated as performance metrics in this document. The implicit acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device in terms of indications for use, technological characteristics, and safety/effectiveness.
   • Reported Device Performance: No quantitative performance data (e.g., sensitivity, specificity, accuracy) is reported for the Stryker Hip Arthroscopy Set itself. The document states: "The Stryker Hip Arthroscopy Set introduces no new risks to health as compared with existing commercially available devices."

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

   • Not applicable. No new performance study in a test set is described.

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. No new performance study is described that would require establishing ground truth from experts. The safety and effectiveness statement mentions "orthopedic surgeons now performing various hip arthroscopic procedures," but this is in the context of device design considerations, not as part of a formal ground truth establishment for a study.

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

   • Not applicable. No new performance 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 is a medical device (arthroscope and instruments), not an AI-assisted diagnostic tool.

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

   • Not applicable. This is a medical device, not an algorithm.

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

   • Not applicable. No new performance study is described.

8. The sample size for the training set:

   • Not applicable. No machine learning or AI algorithm development is described.

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

   • Not applicable. No machine learning or AI algorithm development is described.

Summary based on the provided text:

The Stryker Hip Arthroscopy Set is cleared based on demonstrating substantial equivalence to predicate devices (Karl Storz arthroscopes, Smith & Nephew, Karl Stroz, and Arthrex manual instruments). The clearance does not rely on a new clinical study with specific acceptance criteria and performance data for this particular device. Instead, the assumption is that since the device has similar technological characteristics and indications for use as previously cleared devices, it poses no new safety or effectiveness concerns.

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