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The Novadag Disposable Rigid Scope Introducer is intended to facilitate passage of a laparoscope through the anus allowing visual examination of the rectum and distal portions of the colon.

The single-use Disposable Rigid Scope Introducer is used in conjunction with a laparoscope to allow visual examination of the rectum and distal portions of the colon. When used with the laparoscope, the Disposable Rigid Scope Introducer and laparoscope are advanced into the rectum under visual guidance to a maximum insertion length of 25cm. An insufflation port is provided as part of the Endoscopic Introducer to allow insufflation of the rectum and lower colon.

The provided document does not contain information about specific acceptance criteria, a study proving device meeting acceptance criteria, or performance metrics. It is a 510(k) summary for a medical device (Disposable Rigid Scope Introducer) seeking substantial equivalence to predicate devices. The document outlines:

1. Device Description: The Novadaq Disposable Rigid Scope Introducer is a single-use device used with a laparoscope for visual examination of the rectum and distal colon, featuring an insufflation port.
2. Indications for Use: To facilitate the passage of a laparoscope through the anus for visual examination of the rectum and distal portions of the colon.
3. Predicate Devices: K092221 Colonic Splinting Overtube (US Endoscopy), K033954 Shape Locking Endoscopic Overtube (USGI Medical Inc.), K770291 Disposable Rigid Sigmoidoscope (Welch Allyn).
4. Technological Comparison: The device is considered similar to predicates in shape, materials, and effect on the patient. Differences include length (shorter than predicates) and the provision of an insufflation channel, similar to one predicate.
5. Nonclinical Tests: Safety and performance were verified by tests conducted by Novadaq Technologies and accredited third-party laboratories, adhering to ISO 10993-1:2009, ISO 8600-1 Second Ed., and ISO 8600-4 First Ed.
6. Clinical Performance Data: An "exhaustive literature search" was conducted via a written protocol, and the clinical evaluation report is based on clinical data from this literature review and an adverse events database. It states that this data "provide evidence that supports the safety and performance claims."
7. Safety & Effectiveness Conclusion: The submission claims that differences do not raise safety/effectiveness questions and the device is substantially equivalent to the referenced predicate devices.

Based on the provided text, I cannot complete the requested tables and information as the document does not include quantitative acceptance criteria, detailed study designs, sample sizes for test/training sets, expert qualifications, or ground truth establishment methods in the way a performance study report would.

The document states that "Data presented in the clinical evaluation report provide evidence that supports the safety and performance claims made for the Endoscopic Introducer," but it does not present that data or the methodology of the studies.

This is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed clinical study report with specific performance metrics and acceptance criteria for a novel algorithm or diagnostic device. For the types of information you're asking for (e.g., AUC, sensitivity, specificity, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance), a different type of document, such as a clinical study report or a more detailed section of the 510(k) itself (which is often proprietary and not included in the summary), would be necessary.

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