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The Stryker Videoscope is a video endoscope indicated for use in endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs.

The Stryker Videoscope is a video endoscope intended to illuminate and allow observation of body cavities relating to general endoscopic, laparoscopic and gynecological surgeries. Traditionally, surgeons would need multiple scopes with varying direction of view angles (such as 0°, 30°, and 45°) to have a wide range of view. The Stryker Videoscope can provide varying angles all in one scope through a distal articulating section that changes the direction of view between 0° and 110° (±10°) from the axis of the scope. The Videoscope will have a working length of 330mm, with an outer diameter of 10mm.

The provided document is a 510(k) pre-market notification for the Stryker Videoscope. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria based on clinical performance metrics. Therefore, many of the requested elements for a detailed study report are not present in this document.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in the format typically seen for a new device's clinical performance study (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating equivalence to a predicate device by comparing characteristics and performance specifications.

The closest to "acceptance criteria" are the standards the device conforms to and the comparison to the predicate device.

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

The document does not describe a clinical "test set" in the context of diagnostic performance (e.g., images for readers to interpret). The "testing" mentioned pertains to engineering verification and validation of physical device characteristics (e.g., mechanical reliability, biocompatibility, sterilization). Therefore, sample sizes for a clinical test set and data provenance (country, retrospective/prospective) are not applicable or provided in this document.

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

As there is no clinical "test set" for performance evaluation against a ground truth in this document, this information is not available.

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

Not applicable as there is no clinical "test set" for performance evaluation.

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 describes a videoscope, which is a viewing instrument, 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 document describes a videoscope, not an algorithm.

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

Not applicable. Ground truth for clinical performance comparison is not relevant to this 510(k) submission for a videoscope. The "ground truth" for the device's characteristics is based on established engineering and manufacturing specifications and testing standards.

8. The sample size for the training set

Not applicable. This document describes a videoscope, not a machine learning model that requires a training set.

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

Not applicable. This document describes a videoscope, not a machine learning model that requires a training set.

Summary of the Study and Device Approval:

The document describes a 510(k) pre-market notification for the Stryker Videoscope. The "study" presented here is a demonstration of substantial equivalence to a predicate device (Olympus Laparo-Thoraco Videoscope XLTF-VAW, K053382), rather than a clinical performance study with defined acceptance criteria and statistical analysis.

The document claims that the Stryker Videoscope meets acceptance criteria implicitly by:

• Having the same intended use as the predicate device.
• Conforming to various voluntary safety and performance standards (e.g., ISO 10993 for biocompatibility, IEC 60601-1 for electrical safety, ISO 8600 for endoscope requirements, EN 550 for sterilization).
• Undergoing (or committing to undergo) verification and validation testing for mechanical reliability, biocompatibility, and sterilization, ensuring it meets these relevant safety and performance standards.
• Minor technological differences (such as outer diameter, FOV, bending angulations, and absence of an inner working channel) are argued not to raise new questions regarding safety or effectiveness and are explained with rationale (e.g., smaller FOV allows better image quality, increased articulation offers more flexibility).

The FDA's decision to clear the device K082451 confirms that based on the presented information, the device is considered substantially equivalent to the predicate device and therefore "as safe and effective."

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