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These instruments have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.

The proposed Ensure™ Single-Use Coagulation Forceps is a sterile, single-use endoscopic device, intended to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract. The proposed device is only for adult patients. The Coagulation Forceps is a hemostasis device which combines both mechanical property and energy. It consists of a jaw, coated spring sheath, high frequency electrical interface and handle. The Coagulation Forceps can be advanced through an appropriate endoscope channel to reach targets and by pushing and pulling its Finger Ring of the handle, the forceps opens and closes. The bleeding point will be clamped with the Coagulation Forceps. At that point, high-frequency and high-voltage power will be delivered at the precise site of bleeding using an electrosurgical current generator so as to achieve hemostasis. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 2 years.

This submission is for a medical device called the Ensure™ Single-Use Coagulation Forceps, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies related to AI/ML device performance (such as sample size for test sets, expert qualifications, and effect size of AI assistance) is not applicable.

The provided document describes the substantial equivalence of the subject device to a predicate device based on technological characteristics and performance data from bench tests, biocompatibility testing, sterilization validation, and electrical safety standards.

Here's the relevant information that can be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with reported performance values. Instead, it lists the types of tests performed and states that the proposed device "meets the requirements" of various ISO standards and that "The tests performed demonstrated that the proposed device and predicate device are substantially equivalent."

Here's a summary of the performance claims based on the provided text:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes for the bench tests. The tests were performed by Micro-Tech (Nanjing) Co., Ltd. in China, so the data provenance is likely from their facilities. The tests are bench tests, not clinical studies, so the terms "retrospective or prospective" do not directly apply in the usual clinical context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this is a medical device and not an AI/ML diagnostic system requiring expert consensus on image interpretation or similar. The "ground truth" for these tests are the established engineering and biological standards.

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

Not applicable, as there is no human interpretation or adjudication described for these engineering and biological performance tests.

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/ML device, and no MRMC study or AI assistance is mentioned.

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.

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

The "ground truth" for the device's performance is based on the adherence to established international and national standards for medical devices, including:

• ISO 10993-1: Biological Evaluation of Medical Devices
• ISO 11135: Sterilization of Health Care Products
• ISO 10993-7: Ethylene Oxide Sterilization Residuals
• ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
• IEC 60601-1 series: Medical Electrical Equipment - General requirements for basic safety and essential performance, and collateral standards for specific applications (e.g., high frequency surgical equipment).

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

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