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Stryker Arthroscopes are endoscopic devices into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. Arthroscopes are indicated for use in arthroscopic procedures performed in the hip, knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle elbow, and feet (plantar fascia release).

Stryker Arthroscopes are tubular optical instruments used to provide a view of internal patient anatomy for examination, diagnosis, and therapy during arthroscopic procedures. The devices are available in a variety of outer diameters and working lengths.

The arthroscopes are reusable devices initially supplied as non-sterile to the user and requiring the user to process the device for initial use, as well as to reprocess the device after each use. The devices are available in an evepiece and a C-Mount design. The evepiece arthroscopes connect to the camera system through a separate coupler; the C-Mount arthroscopes connect directly to the camera system through an integrated coupler.

Stryker's arthroscopes achieve their intended use by guiding light to illuminate and image an arthroscopic joint, then relaying the image out of the surgical site for processing and display by a separate camera system. The arthroscopes' optical system consists of a series of lenses, which includes an objective lens to image the intended object, a relay rod lens system to transmit the image along the working length, and an ocular lens to form the final image size.

The provided document is a 510(k) Summary for the Stryker Arthroscopes. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies on AI algorithms or advanced performance metrics. As such, the document does not contain the information required to answer many of the questions asked, particularly those related to acceptance criteria, AI performance, ground truth, and sample sizes for AI studies.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document provides a table of tests performed and their results, but it does not explicitly state the acceptance criteria for each test. It only indicates "PASS" for all tests.

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

This information is not provided in the document. The document describes tests primarily related to the physical and functional aspects of the arthroscope (electrical safety, packaging, biocompatibility, cleaning, sterilization, mechanical performance), not data-driven performance studies typically associated with AI/software devices.

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)

This information is not provided. The device is an arthroscope, a physical optical instrument. The tests mentioned are for its physical and functional characteristics, not for diagnostic accuracy that would require expert-established ground truth.

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

This information is not provided. As explained above, the tests are primarily for physical and functional performance, not diagnostic accuracy requiring adjudication.

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

There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance in this document. The device is a traditional arthroscope, not an AI-powered diagnostic tool.

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

There is no mention of an algorithm or standalone performance in this document.

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

This information is not applicable/provided. The performance tests are for physical device characteristics, where "ground truth" would be defined by engineering specifications and standards, not clinical diagnostic outcomes.

8. The sample size for the training set

There is no mention of a training set as this is not an AI/machine learning device.

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

There is no mention of a training set or its ground truth, as this is not an AI/machine learning device.

Summary based on available information:

The provided document is a 510(k) summary for a traditional medical device (Stryker Arthroscopes) and demonstrates substantial equivalence to a predicate device based on design, intended use, operating principles, technological characteristics, and safety features. The performance testing focuses on standard engineering, safety, and reprocessing validations rather than AI-specific performance criteria or clinical diagnostic accuracy studies. Therefore, most of the questions related to acceptance criteria for AI performance, ground truth, and sample sizes for AI studies cannot be answered from this document.

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Stryker Arthroscopes are endoscopic devices introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. Arthroscopes are indicated for use in arthroscopic procedures performed in the hip, knee, shoulder, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release).

Stryker Arthroscopes are endoscopic devices introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. The Stryker Arthroscope is a long tube containing a series of lenses. At the distal end, an objective lens captures the image of the object. Lens along the rod relay the image. At the proximal end, a proximal coupling lens relays the image to a CCD (Camera).

The Stryker Arthroscopes come in various diameters including 1.9mm, 2.7mm, and 4.0mm. Larger size arthroscopes are used for general viewing, while smaller diameter arthroscopes are used for restricted surgical sites. The Stryker Arthroscopes come in several directions of view including, 0°, 30°,45°, 70°. The direction of view enables viewing of different parts. Materials of the Arthroscope include stainless steel, titanium, PEEK, Glass, and Sapphire.

The provided text describes a 510(k) summary for the Stryker Arthroscope, focusing on establishing substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific performance acceptance criteria based on clinical outcomes or diagnostic accuracy.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not applicable or cannot be extracted from this document, as it concerns a medical device (an arthroscope) that's primarily a viewing instrument for internal examination. The "performance testing" mentioned refers to engineering and safety standards, not clinical performance in terms of diagnostic accuracy or reader improvement.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, AUC) or diagnostic accuracy. Instead, it demonstrates compliance with voluntary safety and performance standards and highlights technological characteristics compared to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. The document discusses performance testing related to engineering standards (biocompatibility, electrical safety, sterilization, optics) and a comparison of technological characteristics to a predicate device. It does not describe a clinical "test set" in the context of diagnostic accuracy or clinical outcomes.
• Data Provenance: Not applicable for clinical performance data. The data presented is from internal engineering tests and a comparison to a predicate device's specifications.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable. This type of information is relevant for studies involving human interpretation or clinical judgment. The 510(k) pertains to the physical and functional characteristics of an arthroscope, not its interpretative output.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no "test set" of cases requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No, an MRMC study was not done. The device is an arthroscope, a visually guided surgical instrument, not an AI-powered diagnostic or interpretive tool.
• Effect Size of Human Reader Improvement: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance Study: No, a standalone performance study in the context of an algorithm's diagnostic accuracy was not done. The Stryker Arthroscope is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the context of clinical outcomes or diagnostic accuracy. For the engineering performance tests, the "ground truth" would be defined by the specifications in the relevant ISO and IEC standards (e.g., a material is biocompatible if it passes ISO 10993 tests; an arthroscope meets optical resolution if it conforms to ISO 8600-5). The substantial equivalence claim is based on direct comparison of design and material specifications between the proposed device and the predicate device.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable.

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