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The Snowden-Pencer Laparoscopic Ergonomic Reposable Scissors is a monopolar electrosurgical instrument indicated to be used in general laparoscopic and gynecologic procedures to allow high frequency monopolar cutting and coagulation. The reposable scissors are indicated to mechanically cut tissue and suture.

The Snowden-Pencer™ Laparoscopic Ergonomic Reposable Scissors is a monopolar electrosurgical instrument that is intended to produce a specific tissue effect such as dissecting, cutting, or coagulation by directing a variety of electrical high frequency currents through to a target tissue without causing damage to non-target tissue. The scissors are designed to fit through a 5 mm trocar and are intended to cut, dissect and coagulate tissue during general laparoscopic and gynecological procedures. The device can be used in either the electrified or non-electrified state. The device has a disposable shaft and scissors tip (scissors insert) and a reusable handle. The scissors are available in three lengths 24, 36 and 45 cm and three blade designs: curved metzenbaum, mini-metzenbaum and hook. The disposable scissors insert is provided sterile and is for single use only. The handle can be reused following cleaning and sterilization and is supplied non sterile.

The provided text describes a 510(k) summary for the Snowden-Pencer™ Laparoscopic Ergonomic Reposable Scissors. This document focuses on demonstrating the substantial equivalence of the modified device to existing predicate devices, rather than detailing a study proving the device meets specific acceptance criteria in the sense of a clinical trial for a novel AI device.

However, I can extract the "acceptance criteria" from the performance tests conducted and the "reported device performance" from the testing conclusions for this medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information, the document is for a medical device (surgical scissors) and not an AI device. Therefore, many of the requested points are not applicable or cannot be extracted from this type of regulatory submission.

Here's an attempt to address the other points, noting their inapplicability where relevant:

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

• Sample Size: Not explicitly stated in terms of a "test set" for performance metrics like cutting, coagulation, and electrosurgical safety. For biocompatibility and sterilization, the "sample size" would relate to the number of units tested, but this detail is not provided.
• Data Provenance: The tests are described as "Bench top and design validation testing." This implies internal testing conducted by the manufacturer (CareFusion 2200 Inc., McGaw Park, IL, USA). The data is retrospective in the sense that it was generated prior to submission for regulatory clearance.

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

• Not applicable. This is not an AI study requiring expert ground truth labeling. Performance tests for electrosurgical devices typically involve objective measurements against established standards rather than subjective expert assessment of outputs.

4. Adjudication method for the test set:

• Not applicable. This is not an AI study involving human expert judgment. Performance is assessed against quantitative standards.

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 not an AI device. No MRMC study was performed. The document explicitly states: "N/A - No clinical tests were conducted for this submission."

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

• Not applicable. This is a physical medical device, not an algorithm. Benchtop tests are inherently "standalone" in the sense that they assess the device's inherent physical and electrical properties.

7. The type of ground truth used:

• The "ground truth" for this device's performance tests would be established by:
  • Objective measurement against engineering specifications (e.g., electrical rating, cutting force, coagulation effectiveness).
  • Compliance with recognized international standards (IEC, ISO) for medical device safety and performance.
  • Material properties and biological response based on standardized biocompatibility tests.
  • Sterility Assurance Level (SAL) based on validated sterilization protocols.

8. The sample size for the training set:

• Not applicable. This is not an AI device that requires a training set.

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

• Not applicable. This is not an AI device that requires a training set.

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