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The OmniSonics Endoscopes are intended for visualization of body cavities, hollow organs, and canals. The OmniSonics Endoscopes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the endoscope. The OmniSonics Endoscopes are indicated for the following applications: Ureteroscopy, Bronshoscopy, Thoracoscopy, Nasopharyngoscopy, Sinuscopy, General laparoscopy, Urology, Gynecological.

The OmniSonics Endoscopes are fiber optic designed endoscopes offered in a variety of lengths, diameters and configurations for user convenience. The fiberoptic endoscope functions by light being transmitted from a standard external high intensity light source through illumination fibers to the distal tip of the scope. The image is transmitted via a fiber-imaging bundle to an eyepiece. The image is viewed directly or transmitted through a video camera to a monitor. The device is provided with a reusable coupler and is also compatible with other standard couplers currently marketed.

The provided text is a 510(k) premarket notification for the OmniSonics Flexible Fiber Optic Endoscope and Coupler. It is a submission to the FDA seeking approval to market a medical device, asserting its substantial equivalence to already legally marketed devices.

Based on the provided information, the device is not a diagnostic AI device and therefore does not have the types of acceptance criteria and studies typically associated with AI/ML-driven diagnostic tools.

Here's a breakdown of why and what information is available:

This device is a traditional medical instrument (fiber optic endoscope), not an AI/ML-driven diagnostic device. The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices based on design, intended use, technological characteristics, and materials, rather than performance metrics for diagnostic accuracy.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable in this context.

Here's what can be extracted and inferred from the text regarding the device and its "testing":

1. Table of Acceptance Criteria and Reported Device Performance:

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 does not describe a clinical performance study with a test set of data for diagnostic accuracy. The "testing" mentioned refers to engineering compliance and material biocompatibility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No diagnostic "ground truth" was established as this is not a diagnostic device in the AI sense.

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

• Not applicable.

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:

• No. This is not an AI device, and therefore no MRMC study for AI assistance was performed.

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

• Not applicable. This is not an AI algorithm.

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

• Not applicable. The "ground truth" here is the established safety and performance requirements for endoscopes via standards (IEC 60601-2-18) and the established characteristics of predicate devices.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

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