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The USGI ShapeLock Endoscopic Guide is intended to be used with an endoscope to to facilitate intubation, e.g., colonoscopy, change of endoscopes, and removal of multiple polyps and/or foreign bodies.

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I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "USGI ShapeLock Endoscopic Guide," indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The letter mentions:

• Trade/Device Name: USGI ShapeLock™ Endoscopic Guide
• Regulation Number: 21 CFR §876.1500 (Endoscope and accessories)
• Regulation Name: Endoscope and accessories
• Regulatory Class: II
• Indications For Use: To be used with an endoscope to facilitate intubation, e.g., colonoscopy, change of endoscopes, and removal of multiple polyps and/or foreign bodies.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study, including sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested information based on the given text.

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