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The Monopolar Laparoscopic Accessories is a family of instruments which includes forceps, scissors, and probes which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar electrosurgical cutting and/or coagulation.

The Monopolar Laparoscopic Accessories includes Grasping Forceps, Monopolar Scissors, and Monopolar Probe/Electrodes. The devices are disposable, single use, individually packaged devices that are composed of biocompatible materials. Scissors and forceps have a handle with rotating wheel attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and their generators. Probes/Electrodes have an insulated shaft with a thermally conductive metal tip electrode. The proximal end of the shaft is attached to a handle made of an injection molded, medical grade plastic.

This document describes the premarket notification (510(k)) for Unimicro Medical Systems' Monopolar Laparoscopic Accessories. It focuses on demonstrating substantial equivalence to a predicate device, not on specific AI device performance. Therefore, many of the requested categories related to AI performance, such as sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, and training set details, are not applicable in this context.

Here's a breakdown of the available information:

1. Table of acceptance criteria and reported device performance:

The document describes the types of tests performed and indicates that the device met the pre-defined acceptance criteria, but it does not provide a table with specific quantitative acceptance criteria or detailed results. Instead, it states: "All the test results demonstrate the performance of Monopolar Laparoscopic Accessories meets the requirements of its pre-defined acceptance criteria and intended uses." and "The results of the non-clinical testing demonstrate that the Monopolar Laparoscopic Accessories is as safe and effective as the predicate devices."

The tests conducted include:

Note: The document references safety tests conducted in accordance with several IEC and ISO standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 11135-1). These standards would contain specific acceptance criteria, but they are not detailed in this submission summary.

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

• Sample Size: Not specified. The document mentions "a series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests," but does not provide specific sample quantities for each test.
• Data Provenance: The tests were conducted by the manufacturer, Unimicro Medical Systems (ShenZhen) Co., Ltd. The document does not specify the country of origin for the data (e.g., patient data, if applicable), as the tests are primarily bench/biocompatibility tests on the device itself. The study appears to be entirely prospective in the sense that these tests were conducted specifically for this submission.

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

• This is not applicable for a medical device that does not involve diagnostic or AI-driven interpretations requiring expert ground truth. The tests are physical, mechanical, and biocompatibility assessments.

4. Adjudication method for the test set:

• Not applicable, as this is related to expert consensus for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

• No, an MRMC study was not done. This device is a surgical accessory, not an AI diagnostic tool that would typically involve human readers interpreting cases.

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

• Not applicable. This device is a physical surgical tool and does not employ an algorithm.

7. The type of ground truth used:

• The "ground truth" for the device's performance is based on the specifications outlined in the referenced international standards (e.g., IEC, ISO) for physical, mechanical, and biocompatibility properties. The tests assess whether the device meets these engineering and safety standards.

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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