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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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