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The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile Tip is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy. gastroscopy. colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy.

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

The OmniGuide OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile Tip is an accessory for CO2 laser systems. It consists of a flexible fiber assembly that delivers CO2 laser energy that enables minimally invasive surgery. OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with low profile metal tip is supplied sterile and is intended for single procedure use in conjunction with the OmniGuide Laser Adapter.

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 and a stainless steel waveguide distal tip. The fiber assembly is 1 to 2 m long and transmits at the CO2 laser emission wavelength of 10.6 um. The fiber has 14 mm long stainless steel tip that is used as a continuation of the waveguide, which enhances visualization in tight areas.

The provided 510(k) summary for the OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile Tip indicates that formal clinical trials were not deemed necessary. Instead, the device's performance was evaluated through non-clinical testing and comparison to predicate devices, claiming substantial equivalence.

Therefore, many of the specific questions about clinical study design, sample sizes, expert involvement, and ground truth establishment cannot be answered from this document as such a study was not conducted.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Inferred" Acceptance Criteria: The document states that performance characteristics were evaluated through "testing and analysis of laser power output and beam quality." It also mentions "energy transmission levels and beam quality" as major performance parameters that are "similar or equivalent to the characteristics of above mentioned legally marketed devices." This implies that the acceptance criteria for these parameters were met if they were found to be comparable to the predicate devices.

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

Not applicable. Formal clinical trials or test sets with human data were not conducted. The evaluation was based on non-clinical performance data (testing) and comparison to predicate devices.

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

Not applicable. Ground truth for a clinical test set was not established as no such test set was used.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was used that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No clinical study, MRMC or otherwise, was conducted.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical medical instrument (laser fiber), not an algorithm or AI. The performance evaluation was for the physical characteristics of the device.

7. Type of Ground Truth Used

The "ground truth" for the device's performance was established through non-clinical performance testing (laser power output and beam quality) and comparison to the characteristics and intended use of legally marketed predicate devices. No pathology, expert consensus, or outcomes data from a clinical setting were used as ground truth for this submission.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set or its associated ground truth establishment.

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