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The Kogent Disposable Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue. The Kogent Disposable Irrigating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.

This device is a disposable bipolar forceps, designed for single use in electrosurgical procedures. They require connection with a suitable bipolar cable to the bipolar output of an electrosurgical generator. These forceps are designed to grasp, manipulate, coagulate, and irrigate, when applicable, selected tissues. The irrigation tube is designed to carry fluid to the tips of the instrument. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator and activated by a footswitch. The devices are provided sterile by ethylene oxide and in sterile packs.

The provided text describes performance testing for the "Kogent Bipolar Forceps" as part of a 510(k) submission to demonstrate substantial equivalence to predicate devices. The study conducted is primarily bench testing focusing on electrical safety and mechanical integrity for an electrosurgical device, rather than a clinical study evaluating an AI algorithm's diagnostic or predictive performance.

Therefore, many of the requested fields are not applicable to this type of device and study.

Here's the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For "Dielectric Withstand" and "Resistance/Continuity", the "Result" column is empty in the original table, so it is marked as N/A here. However, since the overall summary states that "Performance" is "Identical" to predicate devices, it can be inferred that these tests also passed or met the criteria.

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

• Sample Size: Not explicitly stated. For bench testing of medical devices like forceps, the sample size usually refers to the number of devices tested. This information is typically detailed in the full test report, not in the 510(k) summary.
• Data Provenance: This is bench testing data, not human patient data. It is generated during the device's manufacturing and quality control process. The country of origin of the data would be the location where Katalyst Surgical, LLC conducted its testing, likely the USA (Chesterfield, MO, as per the manufacturer's address). The data is prospective in the sense that it pertains to the newly manufactured Kogent Bipolar Forceps being submitted for clearance.

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

• N/A. This study is not evaluating an AI algorithm or a diagnostic tool that requires expert-established ground truth from medical images or clinical data. The "ground truth" for this device's performance testing is established by engineering standards and specifications (e.g., IEC 60601-2-2).

4. Adjudication Method for the Test Set

• N/A. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical cases. This is bench testing against established engineering standards. The pass/fail criteria are objective metrics based on those standards.

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

• No. This is not an AI-enabled device, nor is it a diagnostic tool where human reader performance would be evaluated with or without AI assistance. This section is not applicable.

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

• N/A. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Engineering Standards and Specifications: The ground truth for this device's performance is defined by established international and national standards for electrosurgical equipment, specifically IEC 60601-2-2, and the internal design specifications of the device. These standards define the acceptable limits for parameters like leakage current, dielectric strength, and anchorage.

8. The Sample Size for the Training Set

• N/A. This is not an AI algorithm requiring a training set.

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

• N/A. This is not an AI algorithm requiring a training set.

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