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Like the predicate devices, the asap endoscope is used to visualize the body cavities, hollow organs and canals during diagnostic and, in conjunction with additional instruments, therapeutic procedures.

The asap endoscope is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system.

The basic design of the asap endoscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.

This 510(k) submission for the Asap Endoscope describes a substantial equivalence determination rather than a study with specific acceptance criteria and performance metrics for a novel device. Therefore, a table of acceptance criteria and reported device performance, information regarding sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, and details on training sets for AI models are not applicable to this document. These would be relevant for devices that utilize AI or have new performance claims requiring specific clinical studies.

The provided document primarily focuses on establishing substantial equivalence to previously cleared predicate devices based on design, materials, and intended use.

Here's an analysis of the information that is available in the document, framed by the spirit of your request:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria (Implied by Substantial Equivalence): The primary "acceptance criterion" for this submission is that the asap endoscope must be "substantially equivalent" to its predicate devices in terms of safety and effectiveness. This is demonstrated by showing that its specifications, intended use, materials, and sterilization properties are comparable to those of the predicate devices.
• Reported Device Performance: The document states that "The specifications and intended use of the asap endoscope are the same to those of the claimed predicate devices." It also confirms that "The ability to repeatedly adequately sterilize the devices has been confirmed by validation protocol." These statements imply that the device performs equivalently to the predicates for its intended use and meets sterilization requirements.

An adapted table based on the document's content would look like this:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This submission relies on a comparison to predicate devices, not on a clinical test set with human or synthetic data to evaluate new performance claims. The "test" in this context is primarily a comparison against existing device specifications and relevant standards. The sterilization validation would have involved a sample size of devices, but the specific numbers and provenance for that internal validation are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No expert review of a test set, as would be required for AI/imaging devices, is conducted or reported here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No adjudication process for a test set is conducted or reported here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a passive optical instrument, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable / Implied: The "ground truth" for this type of submission is the established safety and effectiveness of the predicate devices based on their prior clearances and regulatory compliance. The "truth" is that the asap endoscope's fundamental characteristics (design, materials, intended use) are equivalent to those already accepted by regulatory bodies.

8. The sample size for the training set

• Not applicable. No AI/machine learning training set is involved.

9. How the ground truth for the training set was established

• Not applicable. No AI/machine learning training set is involved.

In summary: The provided 510(k) summary is for a traditional medical device demonstrating substantial equivalence to predicates, not a device with complex performance claims typically associated with AI or advanced diagnostic capabilities that would require the extensive study details requested. The "study" done here is a detailed comparison of the new device to existing, cleared devices and adherence to relevant standards.

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