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The OmniGuide Beam Path OTO-U Fiber for CO2 Laser Systems is indicated for the incision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissue. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry , dermatology, gynecology, 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 laryngology, gastroscopy, colonoscopy, laproscopy, 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 Beam Path OTO-U Fiber is a single use laser surgical instrument provided sterile for use in transmitting laser energy at 10.6 µm from a CO2 Laser System to a surgical site through an endoscope, flexible or rigid or using an accessory handpiece. It is connected to the laser system utilizing a standard ST II stainless steel fitting which is used by many laser manufacturers. The fiber has the following dimensions and composition:

The device consists of an optical fiber assembly. The main functional characteristic is a Silver coating reflector that reflects and thereby contains and guides CO2 laser energy within the fiber. Silver coating is applied along the ID of the cladded fused silica core, allowing 10.6 µm laser energy to be guided along the fiber length and onto a surgical location. The fused silica core is cladded with a thin layer of Fluorinated Acrylate. The core is sheathed with a Tefzel polymer layer.

Helium gas is flowed in the core to provide cooling of the fiber as needed and to prevent contamination of the fiber core.

The fiber assembly is 1 to 2 meters long and transmits at the CO2 laser emission of 10.6 µm. The fiber can be used in single pulse mode, repeat pulse mode and CW mode. Power output is limited to 10 Watts.

The recommended distance between fiber tip and tissue is 3 mm and the recommended gas flow is less than 1 liters per minute.

The FDA medical device approval document provides information about the OmniGuide Beam Path OTO-U Fiber. However, it does not include specific details about acceptance criteria for a clinical study comparing device performance against those criteria, nor does it detail a study proving the device meets acceptance criteria in the way you've outlined for AI/ML device evaluations.

This document describes a 510(k) premarket notification for a Class II medical device (a laser surgical instrument fiber), which focuses on demonstrating substantial equivalence to previously cleared predicate devices. The review is based on non-clinical bench testing and biocompatibility assessments, rather than comparative clinical performance studies with acceptance criteria as one would typically see for AI/ML diagnostic tools.

Here's a breakdown of the information that is available and what is not available based on your request:

Information Available from the Document:

• Device Type: OmniGuide Beam Path OTO-U Fiber for CO2 Laser Systems (a laser surgical instrument accessory).
• Purpose of Submission: To expand the product offering of the OTO product line to include a more flexible modified fiber body, a silver optical reflective coating, and modify the glass configuration of the existing cleared and marketed OTO product offering. This is a modification of an existing technology, not an entirely new diagnostic or prognostic tool.
• Main Characteristic: Silver coating reflector that reflects and guides CO2 laser energy.
• Clinical Performance Data: "Clinical trials were not deemed necessary as the OTO-U is using similar technology, has the same indications for use and has the same intended use." This explicitly states that a clinical study designed to demonstrate performance against acceptance criteria was not performed because substantial equivalence was established through other means.
• Non-Clinical Bench Testing:
  • Biocompatibility: Performed according to ISO 10993-1 and FDA Guidance, for an External communicating device contacting tissue/bone for a limited time (<24 hours). All testing met requirements.
    • Tests included: Hemocompatibility (ISO 10993-4, ASTM F756-08), Cytotoxicity (AAMI/ANSI/ISO 10993-5), Irritation/Intracutaneous (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Pyrogen Test (USP Rabbit Pyrogen Study).
  • Sterilization Validation: Performed according to ISO 11135:2014 Amd:2018. Testing met requirements.
  • Functional Testing: "Functional Testing was performed to ensure the device was equivalent to the predicate devices and that the modified device met the requirements of the design Control Policy. All testing met the predetermined specifications." (Specific "predetermined specifications" are not detailed in this public summary, but are stated to exist).
• Equivalence: The device is deemed substantially equivalent to predicate devices (K093451, K073313) based on similar indications for use, hollow internal lumen, transmission of CO2 laser energy, comparable transmission characteristics, similar laser power and spot size, outer jacket materials, dimensions, patient population, RFID tag, and fittings.

Information Not Available (and likely not applicable for this type of device/submission):

Since this is a laser delivery fiber and not an AI/ML diagnostic device, the following aspects of your request are not relevant or not present in the document. The concept of "acceptance criteria" and "study proving the device meets acceptance criteria" for diagnostic performance (like sensitivity, specificity, AUC) does not apply here.

1. A table of acceptance criteria and the reported device performance (for diagnostic accuracy): Not applicable. The "performance" here relates to functional and safety equivalence rather than diagnostic accuracy.
2. Sample size used for the test set and the data provenance: Not applicable as no clinical diagnostic test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method 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: Not applicable, as this is not an AI/ML diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for diagnostic ground truth. Biological and functional testing used established laboratory and engineering standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary:

The document describes a 510(k) clearance for a medical accessory based on substantial equivalence to predicate devices, supported by non-clinical biocompatibility, sterilization, and functional testing. It explicitly states that clinical trials were not deemed necessary. The nature of this device (a laser delivery fiber) means that the criteria for evaluation are fundamentally different from those applied to AI/ML diagnostic tools that would require a study proving meeting of acceptance criteria for diagnostic performance.

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