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Intended to provide visualization (via a video monitor) and therapeutic access to the lower gastrointestinal tract including, but not limited to the organs, tissues, and subsystems of the large bowel. The device is introduced rectally as with any standard colonoscope, when indications consistent with the requirement for the procedure are observed in adult patient populations.

The ProtectiScope CS, Non-intrapull colonoscope is a software controlled device intended for use to visualize the colon to the level of the cecum. The ProtectiScope CS, Non-intrapull colonoscope includes a system control unit, flexible insertion tube, control body, and umbilicus. The insertion tube features a disposable sleeve that is discarded after the colonoscopy procedure is completed. The ProtectiScope CS, Non-intrapull colonoscope is designed for use in both diagnostic and therapeutic colonoscopy procedures. The insertion tube is designed to accommodate biopsy tools and equipment to remove intestinal polyps and other therapeutic uses. The design change included in this submission is removal of the air assisted push technology feature of the device. The modified Protectiscope CS, Non-Intrapull device is manually advanced through the large bowel for visualization of the colon.

The provided text describes a 510(k) premarket notification for a medical device called the "ProtectiScope CS, Non-intrapull colonoscope." This submission is based on substantial equivalence to a predicate device and focuses on a design change (removal of air-assisted push technology).

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or specifics about training sets or ground truth establishment.

The document is a regulatory submission for premarket clearance and primarily discusses:

• Device Description
• Intended Use and Indications for Use
• Substantial Equivalence to a predicate device (ColonoSight 520B, K032688) with the key difference being the manual advancement of the device.
• FDA's letter confirming substantial equivalence.

Therefore, I cannot provide the requested information for the acceptance criteria and study details.

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