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The ClearCap Distal Attachment has been designed to the distal end of the endoscope to facilitate endoscopic therapy.

The ClearCap Distal Attachment is intended for the following:

• · Gastrointestinal mucosal resection (endoscopic mucosal resection)
• · Keeping the suitable depth of the endoscope's view field

The ClearCap Distal Attachment is a sterile distal attachment intended to improve endoscopic control and to help maintain the clear view by keeping a moderate distance from the tissues during endoscopic surgical procedures.

The ClearCap Distal Attachment is comprised of three main sections: an attaching portion, a distal portion and draining holes. The attaching portion is connecting portion of the attachment to an applicable endoscope; a distal portion is the ending portion of the attachment and the 2 draining holes on the sidewall are to discharge bleeding and some foreign matter.

Applicable lesions are both lower digestive tract (=gastrointestinal (GI) tract) and upper GI tract. The model name FM-CC01, FM-CC05, FM-CC06 and FM-CC07 are for lower GI Tract, and FM-CC02, FM-CC03 and FM-CC04 are for upper GI tract.

It is available in various sizes of diameter to assure the compatibility of various endoscope outer diameters. The average contact time of the product and the mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or resterilized.

This document does not contain the information requested for acceptance criteria and the study proving the device meets them.

The provided text is a 510(k) summary for a medical device called "ClearCap Distal Attachment." While it discusses the device's design, intended use, and comparison to a predicate device to establish substantial equivalence, it specifically states that non-clinical tests were performed, and it does not mention any clinical study or human subject data.

Here's why the requested information cannot be extracted from this document:

• No Acceptance Criteria or Performance Data for a "Study": The document focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and non-clinical performance (e.g., direct comparison testing for gap, endoscope compatibility, viewing, and suction function). It does not present acceptance criteria in the context of a clinical study or report device performance against such criteria.
• No Clinical Study Details: There is no mention of a clinical study, test set, training set, human readers, ground truth established by experts, or MRMC analysis. The device is evaluated through "non-clinical tests."

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and a study that proves the device meets those criteria, as such a study (in the sense of human performance or clinical outcomes) is not described in this document.

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