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The PRECISION Endoscopic Infrared Coagulator (model 5100) with single-use disposable MAXi-guide flexible light guide (model 5100-240-3.2) is intended for treatment of hemorrhoids by the transmission of infrared energy when used as an accessory to a colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.

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The provided document is a 510(k) clearance letter from the FDA for a medical device. This type of document does not contain the details of acceptance criteria or a study proving that the device meets those criteria.

510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not necessarily on detailed clinical performance studies with acceptance criteria in the manner you've described for AI/algorithm performance. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls, but it does not include information on specific performance metrics, ground truth, or study methodologies.

Therefore, I cannot extract the requested information from the provided text.

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The single-use disposable device is intended to allow the physician to temporarily increase the stiffness of a colonoscope when extra rigidity is required.

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I am sorry, but based on the provided text, I cannot provide the detailed information requested regarding the acceptance criteria, study design, and performance metrics for the "SUCCESS Cecal Intubation Assist™ Device".

The document is a 510(k) clearance letter from the FDA, which primarily focuses on stating that the device has been found substantially equivalent to a predicate device. It specifies the regulation number, trade/device name, and indications for use. However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about any specific study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details).

The letter refers to a "premarket notification of intent to market the device" (510(k) submission), which would contain this information, but the submission itself is not provided here.

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