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The OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray is indicated for use in conjunction with OmniGuide's waveguide fibers to enable the surgeon to perform 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.

The OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray is indicated for use in conjunction with OmniGuide's waveguide fibers.

The objectives of the hand-piece are to enable precision control and to stabilize surgeon hand motion. The waveguide fiber is inserted through the proximal end of the hand-piece and fixated so that it is observed at the hand-piece's distal tip. The surgeon wields the hand-piece as a pencil, and advances the hand-piece so that its distal tip is in close proximity to the target tissue to exert the desired effect of the waveguide fiber: incision. excision, ablation, vaporization and coagulation. The surgeon may use the hand-piece distal tip in either non-contact mode or contact mode, and may use the distal tip to enable tissue manipulation.

The sterilization tray is purchased from SYMMETRY MEDICAL USA INC. and sold as a storage and sterilization tray for use with the OmniGuide Fiber Optic Handpieces,

The handpieces consist of a handle and sealing cap consisting of either SS or aluminum, a silicone rubber fiber gripper and a lumen to guide the fiber made of SS hypodermic tubing. The handle/lumen are welded or adhesive bonded to for the unit. Lumen may be bent or straight to facilitate the aiming of the fiber. The tip is may be beveled or straight to improve the fiber visibility, fiber tip protection and blunt dissection.

The provided text describes a 510(k) submission for the OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive de novo clinical trials with predefined acceptance criteria.

Therefore, the requested information regarding acceptance criteria, specific test set details (sample size, provenance, expert number/qualifications, adjudication, MRMC studies), standalone performance, training set details, and ground truth establishment cannot be fully extracted as these are typically part of a more rigorous clinical study design, which was "not deemed necessary" for this particular submission.

Here's a breakdown of what can be inferred or directly stated from the provided text:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for a 510(k) submission is substantial equivalence to an existing predicate device. This means demonstrating that the new device is as safe and effective as a legally marketed device that does not require premarket approval.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The submission relies on "testing and bench top testing" and comparison to a predicate device, not on a formal clinical test set with a specified sample size.
   • Data Provenance: Not specified. The testing was likely conducted in-house by OmniGuide.

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

   • Not applicable as formal clinical trials with expert-adjudicated ground truth were not conducted.

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

   • Not applicable.

4. 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 surgical instrument, not an AI-assisted diagnostic tool.

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

   • Not applicable. This is a hardware device requiring human interaction.

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

   • Not applicable for a clinical test set in this 510(k) submission. The "ground truth" for demonstrating equivalence largely comes from engineering and performance testing data showing the device functions as intended and similarly to the predicate.

7. The sample size for the training set:

   • Not applicable. As this is not an AI/machine learning device, there is no "training set."

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

   • Not applicable.

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