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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 (

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The OmniGuide® TRIO™ handpiece is indicated for the electrosurgical coagulation of soft body tissues and suction of fluids in general and ENT surgical procedures for the specialties of General Surgery, Head and Neck Surgery, Otolaryngology, and Oral surgery (including intra-oral tissues). When used with the OmniGuide® Laser waveguide, it is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues for the added specialties of Dermatology, Neurosurgery, Orthopedic Surgery, Plastic & Reconstructive Surgery, Podiatry and Urology.

The TRIO™ handpiece is a handheld single use device designed to act as a laser waveguide guide/holder for previously cleared waveguides. The TRIO™ handpiece combines three fundamental surgical instrument functions into one lightweight and compact handheld disposable surgical instrument. If enables a surgeon to provide fluid suction, bipolar cautery, and CO2 laser energy without the necessity of changing instruments, saving surgical time for both physician and patient and a corresponding reduction in cost. Laser energy is delivered via a flexible OmniGuide® fiber for minimally invasive surgery.

The instrument is provided sterile and is intended for single use only. The package has an accelerated shelf life of two years.

The sterile package includes a cable to connect the handpiece to an electrosurgical generator. The cables are generic in nature and several varieties available at a hospital/ office will function. The package also includes a small brush for cleaning coagulation tips with adhered material. The TRIO™ handpiece is intended to be used only with the family of OmniGuide® CO2 Laser fibers including Velocity™, Elite™ and Select™ fibers previously cleared in 510(k) K070157.

The OmniGuide® handpiece is intended for use by licensed surgeons only for open surgical procedures listed in the indications for use. The objective of the handpiece is to enable precision control and to stabilize surgeon hand motion. The waveguide fiber is inserted through the proximal end of the handpiece and fixated so that it is observed at the handpiece's distal tip. The surgeon wields the handpiece as a pencil and advances the handpiece so that its distal tip is near the target tissue to exert the desired effect of the waveguide fiber: suction and coagulation. The surgeon may use the handpiece distal tip in either non-contact mode or contact mode and may use the distal tip to enable tissue manipulation, electrosurgical portion is used for coagulation due to bleeding during laser surgery or tissue manipulation.

The TRIO™ handpiece can be used with any Electro-Surgical Unit (ESU) with output power of up to 750 peak to peak voltage (Vp-p) and footswitch actuation. The instrument is provided with a 12-foot bipolar cable with fixed leads. The TRIO™ handpiece instrument can be used with any hospital or office suction apparatus. Fluid aspiration is controlled via a suction control port on the handle of the instrument.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance for the OmniGuide TRIO Handpiece:

The document does not describe a study involving human readers or AI assistance. It focuses on the substantial equivalence of a medical device (a surgical handpiece) to predicate devices through engineering and biocompatibility testing. Therefore, sections related to MRMC studies, human reader improvement, and standalone algorithm performance are not applicable based on the provided text.

Acceptance Criteria and Reported Device Performance

The document describes the performance testing conducted to demonstrate safety and effectiveness. The acceptance criteria are implicitly defined by the successful completion of these tests in compliance with relevant standards.

Study Details (Based on available information)

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

   • The document describes bench-top testing and user validation. It does not specify sample sizes (e.g., number of handpieces tested for each bench-top test or number of users for validation).
   • Data Provenance: The testing was conducted by an "independent testing laboratory (Intertek)" for electrical safety, EMC, usability, and risk management. Bench-top tests (beam clipping, suction, fiber retention, reliability, mechanical robustness, thermal profile), sterilization validation, and biocompatibility tests were also performed. The origin of the sample devices for testing (e.g., specific manufacturing lot, country) is not specified, but it would presumably be from OmniGuide, Inc.

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

   • The document implies that the "ground truth" for the device's performance is compliance with established international standards (IEC, ISO). "User validation" was performed, which would typically involve qualified users (surgeons or surgical staff), but the number and qualifications of these users are not specified.

3. Adjudication method for the test set:

   • Not applicable in the context of this engineering and biocompatibility testing. Compliance was assessed against pre-defined standards and test protocols.

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:

   • No, an MRMC comparative effectiveness study was not done. This device is a surgical handpiece, not an imaging or diagnostic device involving human readers or AI.

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

   • No, this is not an algorithm or software device. The testing focuses on the physical and electrical performance of the surgical handpiece.

6. The type of ground truth used:

   • The ground truth is based on established international standards and regulatory requirements (e.g., IEC 60601-1, ISO 11135, ISO 10993 series) for electrical safety, electromagnetic compatibility, usability, risk management, sterilization, and biocompatibility. Additionally, engineering specifications and functional requirements for aspects like beam clipping, suction, fiber retention, reliability, mechanical robustness, and thermal profile serve as the ground truth.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

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

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The Beacon Advanced CO2 Advanced Energy Laser System is intended to be used in conjunction with the OmniGuide WaveGuide Fibers or the Articulated Arm to be used for the incision, ablation, vaporization and coagulation of body soft tissues including intra-oral soft tissues.

The Beacon Advanced Energy Laser System is a carbon dioxide laser system utilizing RF excited CO2 laser tube. The device is comprised of a system console, with or without an articulated arm terminated with a handpiece or a micromanipulator, a fiber adapter, system control electronics, a touch screen providing a graphical user interface, a covered footswitch, helium gas management system (for using the OmniGuide Waveguide fibers with the system (K140378, K093451, K093251 and K070157. Located in Appendix 6), and operating software.

The laser system delivers laser energy at 10,600 nm in three different output modes: continuous, single pulse and repeat pulse and two waveforms: Continuous Wave (CW) or Super Pulse (SP). The laser energy produced by the laser tube within the laser console is delivered through an articulated arm system terminating in a handpiece or multiple-use attachments or through a fiber adaptor coupling the laser energy into a OmniGuide. The articulating arm allows the laser energy to be delivered through a focusing handpiece or a micromanipulator achieving laser beam spot sizes in the range of 0.2-0.6 mm in the operating field. The Waveguide fibers have been cleared through K140378, K093451, K093251 and K070157.

The Beacon is operated and controlled via Graphical User Interface implemented by proprietary operating software running on single board computer in the laser console.

The operator can control various aspects of the Beacon operation through the Graphical User Interface on the touch screen. The access to the Graphical User Interface and laser operation is password protected to control access. The operator can adjust the lasing modes, pulse rate and duration in case of pulsed modes, set the waveform (CW or SP) and output power. They can also select whether to use fiber or the articulating arm with the micromanipulator or handpieces or other accessories.

Material used are mainly machined or cast aluminum, stainless steel, standard optics for the transmission or the reflection of the CO2 laser wave energy. It is worth noting that all components (mirrors, lenses, fiber and articulating arm) that the COs light travels through are passive and do not alter the wavelength or any other of the fundamental properties of the CO2 Laser.

This document (K180993) describes the OmniGuide Beacon Advanced CO2 Laser System. The acceptance criteria and the study that proves the device meets them are not presented in the format of a typical diagnostic AI/ML device study with performance metrics like sensitivity, specificity, or AUC against a ground truth.

Instead, this device is a surgical laser system, and substantial equivalence is claimed based on similar technological characteristics, intended use, and indications for use to a predicate device, as well as adherence to established electrical safety, electromagnetic compatibility, software, and risk management standards.

Therefore, the requested information elements (1-9) which are typical for diagnostic device studies (especially those involving AI/ML and human-in-the-loop performance) are not directly applicable or available in this submission.

Here's a breakdown based on the provided document:

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

The document does not provide a table with quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity). Instead, the "performance" is demonstrated through compliance with various international standards and the assertion of substantial equivalence to a predicate device.

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

This information is not applicable. The device is a surgical laser, and its performance evaluation for regulatory approval is based on engineering testing (e.g., power output stability, electrical safety) and comparison to a predicate device, not on diagnostic data interpretation by a machine learning model. There is no "test set" in the context of diagnostic data.

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)

This information is not applicable. There is no "ground truth" establishment by medical experts for a diagnostic test set described in this document. The "truth" for this device's performance is compliance with engineering and safety standards.

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

This information is not applicable. There is no test set or adjudication method described for diagnostic performance.

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

This information is not applicable. This is not a diagnostic AI/ML device that assists human readers.

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

This information is not applicable. This is a medical device (a surgical laser), not an AI algorithm.

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

This information is not applicable in the context of diagnostic performance. For hardware and software, the "ground truth" is compliance with documented specifications and international standards (e.g., the laser produces the stated power output, software functions as designed).

8. The sample size for the training set

This information is not applicable. This device does not have a "training set" in the context of machine learning.

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

This information is not applicable. This device does not have a "training set" in the context of machine learning.

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