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The OmniGuide Zero Flow ZF-T 150 WaveGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral / maxillofacial surgery, dentistry, dermatology, endoscopic and open surgical procedures related to gynecology, otorhinolaryngology, gastroenterology, neurosurgery, pulmonary surgery for surgical and aesthetic applications.

The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached.

The OmniGuide Zero Flow ZF-T 150 WaveGuide fiber is an accessory for CO2 laser systems. It consists of a fiber assembly that propagates CO2 laser beams and vents the cooling gases outside of the body. The OmniGuide ZF-T 150 wave guide fiber is supplied sterile and is intended for single procedure use.

The device consists of an optical fiber assembly. The main functional component of the fiber assembly is a photonic bandgap reflector lining its hollow core that reflects and thereby guides CO2 laser energy. The fiber incorporates a lens at the tip which is transparent to the laser beam. The fiber also incorporates a sensor on the fiber tip that allows physicians to determine when the lens becomes obstructed by debris. The fiber assembly is 1.5 m long and transmits at the CO2 laser emission wavelength of 10.6 gm.

This 510(k) summary describes a CO2 laser accessory, the OmniGuide Zero Flow ZF-T 150 WaveGuide Fiber, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the way a clinical trial for diagnostic AI would.

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

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific quantitative "acceptance criteria" or present a table of device performance against such criteria. Instead, it relies on demonstrating equivalence to predicate devices based on "energy transmission levels and beam quality."

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a "test set" in the context of clinical or AI performance evaluation. The "testing and analysis" for laser power output and beam quality appear to be laboratory-based engineering tests. No information regarding sample size for these tests, or data provenance (country of origin, retrospective/prospective) is provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable. The document describes laboratory performance testing of a laser fiber, not a diagnostic device requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated in point 3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC study was performed or described. This is a laser fiber accessory, not an AI-based diagnostic tool that would typically undergo such a study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable as the device is a laser fiber, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance appears to be directly measured physical properties (laser power output, beam quality) via laboratory testing, compared against the characteristics of predicate devices. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for technical performance evaluation.

8. The Sample Size for the Training Set

This information is not applicable. There is no described "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

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