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Disposable Endoscope Injection Needles are used with endoscope to perform endoscopic vascular or submucosal injection in the GI tract.

The Disposable Endoscope Injection Needles consist of a Sliding handle, Handle, Cap, Sheath, Inner Tube, Guide Tube, Connecting tube, and Tip (only Type B). It is available in a variety of configurations with varying needle lengths, gauges and working lengths. Type A and Type B are included in this submission.

The provided text is a 510(k) summary for the Disposable Endoscope Injection Needles. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML medical device.

The document primarily focuses on establishing substantial equivalence to a predicate device based on:

• Device Description: What the device is made of and its configurations.
• Intended Use: How the device is meant to be used.
• Comparison of Technological Characteristics: A table comparing features of the proposed device to a predicate device.
• Non-clinical Performance Data: Mentions conformity to ISO standards for biocompatibility and sterilization, and some bench tests (appearance, physical properties) that "passed."
• Clinical Test Data: Explicitly states, "No Clinical Study is included in this submission."

Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details because these aspects are relevant to AI/ML device evaluations and are not present in this 510(k) for a conventional medical device.

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