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

ClearHemograsper is a monopolar endoscopic instrument intended to coagulate or to perform hemostasis using high-frequency current within the digestive tract. It can assist in endoscopic surgical procedures such as ESD (Endoscopic Submucosal Dissection). ClearHemograsper consists a Slider for opening or closing the Jaw, a Catheter Tube which is a part passing through the working channel of endoscope, a pair of Jaw for catching the bleeding site and for delivering high-frequency current, a plug for connecting with high frequency transmission equipment, and an irrigation port for removing foreign substances by injecting distilled water or saline solution. It is available in various working lengths.

The provided FDA 510(k) clearance letter for ClearHemograsper is for an endoscopic electrosurgical unit and accessories, which is a physical medical device, not an AI/software as a medical device (SaMD). Therefore, the provided text does not contain information on acceptance criteria, test sets, ground truth establishment, or clinical studies typically associated with the evaluation of AI models.

The information requested in the prompt (acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is specific to the validation of AI/SaMD, particularly for diagnostic or prognostic purposes where ground truth and human reader performance are critical.

Since the ClearHemograsper is a physical device used for cauterizing and coagulation, its performance is evaluated through bench testing (e.g., dimension, rotatable performance, pushability, actuation, tensile strength, output value, hemostatic performance, short circuit, catheter tube temperature tests), biocompatibility studies, sterilization validation, shelf-life studies, and electrical safety/EMC testing. Clinical studies were not considered for this submission (as stated on Page 10, Section 13).

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to AI/SaMD metrics.
• Sample sizes, data provenance, expert numbers, adjudication, MRMC studies, standalone performance, or ground truth establishment methods for an AI test set.

The document describes the device's technical specifications and comparisons to a predicate device, focusing on physical and electrical performance, and safety standards for a mechanical/electrical medical device.

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