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The OmniTip™ Side Firing Switchable Tip with Suction/Irrigation is intended for use with any pulsed Holmium: YAG 2.1 micrometer laser with a compatible connector for incision, excision, ablation, vaporization, and coagulation.

The OmniTip Side Firing Switchable Tip with Suction/Irrigation is a fiber optic energy delivery device consisting of a near-contact laser fiber enclosed in a needle assembly of a capillary tube and an external stainless steel shaft. The device is attached to the Omni Multiuse Handpiece through a quick-connect mechanism. A luer connector assembly installed at the proximal end of the device connects the suction/irrigation channel to a pump via an external line.

This document describes the Trimedyne® OmniTip™ Side Firing Switchable Tips with Suction/Irrigation, a laser fiber device. The primary focus of the provided text is the device's substantial equivalence to predicate devices and its intended use, rather than detailed acceptance criteria and a specific study proving those criteria.

Based on the provided information, the device is considered substantially equivalent for its intended use, which is with any pulsed Holmium:YAG 2.1 micrometer laser for incision, excision, ablation, vaporization, and coagulation.

Here's an analysis of the provided text in relation to your request:

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

The document does not specify quantitative acceptance criteria with corresponding performance metrics in a tabular format. The conclusion states: "The device is biocompatible, performs as intended, and has acceptable mechanical properties when used according to its labeling." This is a general statement of compliance rather than a detailed breakdown of acceptance criteria.

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

• Sample Size for Test Set: The document mentions "simulated clinical testing using heart tissue" but does not specify a sample size for this testing. It also references "a series of tests, including mechanical, biological, and performance studies," but again, no sample sizes are provided.
• Data Provenance: Not specified. It's likely the testing occurred at the manufacturer's location in the USA (Trimedyne, Inc., Irvine, CA). Whether the data was retrospective or prospective is not mentioned.

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)

The document states: "A physician's feedback is also used to validate the use of the device in a clinical setting."

• Number of Experts: "A physician" suggests one expert, but it's not explicitly stated.
• Qualifications of Experts: The term "physician" is a general qualification; specific experience or specialty is not provided.

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

Not applicable. The clinical validation involved "a physician's feedback," which doesn't describe a formal adjudication process typically seen in studies involving multiple reviewers for ground truth establishment.

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 laser fiber, not an AI diagnostic or assistance tool, so an MRMC study comparing human readers with and without AI assistance is not relevant. The document does not mention any MRMC study.

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

Not applicable. This is a physical medical device (laser fiber), not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept here.

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

For the "simulated clinical testing," the ground truth was implicitly based on the observed performance during these tests and the "physician's feedback." This would likely involve visual assessment of the tissue effects (incision, ablation, coagulation) and mechanical function, but a formal "ground truth" definition (like pathology) is not explicitly stated.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm. Therefore, there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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