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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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The OmniGuide Laser System with FlexGuide™ Ultra, which includes the FELS 25A Laser, BeamPath Fibers and the FlexGuide™ Ultra handpiece, is indicated for use to enable the surgeon to perform incision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. This system is intended for use with a grasper in the following medical special laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, urologic surgical procedures, otorhinolaryngology surgical procedures.

The OmniGuide Laser System with FlexGuide™ Ultra, which includes the FELS 25A Laser, BeamPath Fibers and the FlexGuide™ Ultra handpiece are used together to perform the intended use above. The FELS 25A Laser and BeamPath Fibers remain unchanged. Additionally, the BeamPath fibers that deliver the laser energy, are cleared for laparoscopic use. The BeamPath Fiber Optic Handpiece (K081939) has been modified to the FlexGuide™ Ultra handpiece, which includes a sterilization tray and are sold as non-sterile reusable devices. The FlexGuide Ultra is a flexible handpiece that consists of three main sections: the proximal rear sealing cap, handpiece body/cannula and distal tip. The material of the FlexGuide Ultra handpiece is stainless steel. The OmniGuide BeamPath fiber (K070157, K093451) is inserted through the flexible handpiece proximal rear sealing cap and is fixated so that it is visualized through two site holes at the handpiece distal tip. The OmniGuide FELS 25A Laser System (K093251) still generates the CO2 laser energy, which is transmitted through the fiber. During the procedure the surgeon grasps and holds the distal tip of the FlexGuide Ultra with a grasper. The FlexGuide Ultra distal tip may be used in either non-contact mode or contact mode. The surgeon may also use the distal tip to enable tissue manipulation.

Here's an analysis of the provided text to extract the requested information about acceptance criteria and a study proving device performance:

The provided document is a 510(k) Premarket Notification for the OmniGuide Laser System with FlexGuide™ Ultra. It aims to demonstrate substantial equivalence to previously cleared devices, not to establish new performance claims against defined acceptance criteria in the traditional sense of a clinical trial. Therefore, much of the requested information (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance metrics) is not applicable or not explicitly provided in this type of regulatory submission. The focus is on demonstrating that the modified device is as safe and effective as its predicate devices.

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

Since this is a substantial equivalence submission, explicit "acceptance criteria" against numerical performance metrics for a new claim are not presented. Instead, the acceptance is based on demonstrating that the modified device (FlexGuide™ Ultra handpiece) does not raise new issues of safety or effectiveness compared to its predicate. The "performance" reported is a qualitative assessment of similarity.

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

• Sample Size for Test Set: Not explicitly stated as a number of distinct "tests" or "patients." The performance testing is described as "Engineering analysis and bench testing." This implies a series of laboratory or functional tests, not a clinical trial with human subjects.
• Data Provenance: Not explicitly stated, but likely internal laboratory data from OmniGuide, Inc. (Cambridge, Massachusetts, USA). The study is retrospective in the sense that it evaluates the modified device against an existing predicate.

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)

• Number of Experts: Not applicable. Ground truth as typically established by experts (e.g., for diagnostic accuracy) is not relevant for this type of engineering and bench testing. The evaluation is against engineering specifications and functional performance.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. This is not a study involving human interpretation of results requiring adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a surgical handpiece, not an AI diagnostic tool that assists human readers.
• Effect Size of AI: Not applicable.

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

• Standalone Performance: Not applicable. This is a physical surgical device, not an algorithm.

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

• Type of Ground Truth: Not applicable in the traditional sense. The "ground truth" for the engineering and bench testing would be successful operation according to the predicate's established performance parameters and the device's design specifications. This would involve objective measurements (e.g., mechanical integrity tests, energy delivery verification) rather than human interpretation or pathology.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a physical device, not a machine learning model requiring a training set.

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

• Ground Truth for Training Set Establishment: Not applicable.

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