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The U.S. Surgical Auto Suture* Laparoscope** device has indication solely for illumination and visualization of internal structures in a wide variety of diagnostic and therapeutic laparoscopic and thoracoscopic procedures.

The U.S. Surgical Laparoscope** device is a reusable and rigid laparoscope based on existing laparoscopy technology.

The provided text is a 510(k) summary for the Auto Suture* Laparoscope** Device. It primarily focuses on demonstrating substantial equivalence to a predicate device (Imagyn MicroLap™ Laparoscope K965055) rather than presenting a detailed study with acceptance criteria and specific performance metrics.

Therefore, the document does not contain information to construct a table of acceptance criteria and reported device performance, nor does it describe a study proving the device meets particular acceptance criteria.

Here's why and what information is missing:

• Acceptance Criteria and Device Performance: The summary does not define any specific performance metrics (e.g., optical resolution, field of view, illumination intensity, durability, safety parameters) or corresponding acceptance criteria. It broadly states the device is "a reusable and rigid laparoscope based on existing laparoscopy technology" and intends for "illumination and visualization."
• Study Description: The document is a regulatory submission for substantial equivalence, not a clinical or engineering study report. It states that "All component materials of the laparoscope are comprised of materials which are in accordance with ISO Standard # 10993-1," which refers to biocompatibility, but this isn't a performance study.

Missing Information:

1. Table of Acceptance Criteria and Reported Device Performance: Not present in the document.
2. Sample size used for the test set and the data provenance: Not mentioned as no specific test set study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as 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: Not indicated. The document focuses on device characteristics and intended use, not clinical efficacy or reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a physical medical device, not an AI algorithm.
7. The type of ground truth used: Not applicable as no ground truth for performance evaluation is described.
8. The sample size for the training set: Not applicable as this is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) summary serves to demonstrate substantial equivalence by comparing the new device's design, materials, and intended use to a legally marketed predicate device, rather than providing detailed performance study results with specific acceptance criteria.

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