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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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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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The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip is indicated for the 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, 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 laryngoscopy, gastroscopy, colonoscopy, laparoscopy, 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 OmniGuide BeamPath CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip is an accessory for CO2 laser systems. It consists of a flexible fiber assembly that delivers CO2 laser energy that enables minimally invasive surgery. OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss metal tip is supplied sterile and is intended for single procedure use in conjunction with the OmniGuide Laser Adapter.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

Acceptance Criteria and Study Details for OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip (K093451)

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of the Acceptance Criteria (Implied):

The document does not explicitly list numerical acceptance criteria. Instead, the "Performance Data" section states that the device's performance characteristics (laser power output and beam quality) were evaluated through testing and analysis. The acceptance for these characteristics is implicitly defined by their comparability to legally marketed predicate devices. The new feature of "Low Profile/Low Loss Tip" specifically addresses tip heating, indicating that its performance in continuous wave mode without excessive heating was a key acceptance point. The overall conclusion reinforces the equivalence of energy transmission levels, beam quality, and intended use as the basis for acceptance.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated. The document mentions "testing and analysis of laser power output and beam quality." This suggests a series of technical bench tests on the device itself, rather than a sample of patients or cases.
• Data Provenance: The "Non-clinical Performance Data" section implies that the testing was conducted internally by OmniGuide, Inc. (the submitter). The data would therefore be retrospective in terms of being collected prior to the 510(k) submission and for the purpose of demonstrating equivalence. There is no mention of country of origin for this testing, but given the submitter's location (Cambridge, MA), it is highly likely to be United States.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. The "ground truth" for this device's performance is based on engineering specifications and direct measurements of physical properties (laser power output, beam quality, tip temperature). There were no human experts establishing ground truth in the context of clinical interpretation or diagnosis.
• Qualifications of Experts: Not applicable for establishing ground truth in this context. The "experts" involved would have been engineers and technicians conducting the non-clinical performance testing.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This was a technical performance study, not a study requiring adjudication of expert opinions or clinical outcomes. The "adjudication" would have been the comparison of the measured performance data to the established performance characteristics of the predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. The document explicitly states: "Clinical Performance Data: Formal clinical trials were not deemed necessary as the device is using the same technology and intended use as the predicate devices." This indicates that no human-in-the-loop clinical studies were conducted, thus no MRMC study.
• Effect size of human reader improvement with AI vs. without AI assistance: Not applicable, as this device is a surgical fiber for laser energy delivery, not an AI-assisted diagnostic or interpretative tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? Yes, in essence. The "Non-clinical Performance Data" represents a standalone evaluation of the device's physical performance characteristics (laser power output, beam quality, tip heating) against engineering benchmarks and predicate device performance. This assesses the device's function directly without human interaction beyond operating the device for testing purposes.
• Description: The study involved "testing and analysis of laser power output and beam quality." The comparison to predicate devices served as the benchmark for "standalone" performance.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was primarily engineering specifications and measured physical performance data from established predicate devices. The predicate devices' "energy transmission levels" and "beam quality" served as the reference points for comparison. The performance in terms of "reduced tip heating" was also a key physical characteristic that was measured and compared to previous versions or requirements.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a physical medical instrument (laser fiber), not an AI/algorithm-based system that requires a "training set" of data in the machine learning sense. The development and design of the fiber would have relied on engineering principles, materials science, and possibly iterative design and testing, rather than an explicit "training set."

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable. As mentioned above, there is no "training set" for this type of device. The "ground truth" during the device's engineering and development phase would have been established through physics, material science data, prior art, performance standards, and experimental results from prototypes.

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The OmniGuide BeamPath FELS 25A, CO2 Laser System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues in the following specialties:

• . Dermatology
• General Surgery .
• Gynecology .
• Head & Neck Surgery .
• Neurosurgery .
• Oral Surgery ●
• Orthopedic Surgery .
• Otorhinolaryngology .
• Pediatric Surgery ●
• Plastic & Reconstructive Surgery
• Podiatry .
• · Urology

The OmniGuide BeamPath® FELS 25A, CO2 Laser System intended to be used in conjunction with the OmniGuide BeamPath Adapter and the OmniGuide BeamPath fiber and is intended to be used for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues.

The OmniGuide BeamPath FELS 25A, CO2 Laser System, is a Carbon dioxide (CO2) Laser emitting light at a wavelength of 10.6 um. It has an RF excited laser tube which produces a maximum continuous wave (CW) output power of up to 30 watts. Laser energy (CO2), with a wavelength of 10.6 um, has a variety of attractive features for surgical use. Because it is strongly absorbed by water (the main constituent of biological tissue) it does not penetrate into tissue beyond the point of application of the laser energy. This small depth of penetration (0.1-0.2 mm) leads to high cutting precision and minimal thermal damage to adjacent tissue. In addition, the CO2 wavelength has excellent coagulation capabilities.

The laser console is a table top console which can be easily transported from one surgery room to the other. The controls for the physician are part of the console and the parameters are clearly displayed on a large screen display. The laser light is guided through different mirrors and focused via an attached adapter is the interface allowing an OmniGuide BeamPath Fiber or equivalent to attach to the laser.

Materials used are mainly machined aluminum or stainless Steel and standard optics for the transmission or the reflection of the CO2 laser wave length. Only the laser energy from the OmniGuide BeamPath FELS 25A, CO2 Laser System comes in contact with the patient. The energy is guided through a hollow waveguide such as the OmniGuide BeamPath hollow waveguide liber. It is worth noting that all components (mirrors, lenses and the fiber) that the CO2 light travels though are passive and do not alter the wayelength or any other of the fundamental properties or beneficial attributes of the CO2 Laser.

The OmniGuide BeamPath® FELS 25A, CO2 Laser System is a surgical CO2 laser designed for incision, excision, ablation, vaporization, and coagulation of soft tissues. The acceptance criteria and the study proving it meets these criteria are outlined below.

Acceptance Criteria and Reported Device Performance

The device's performance was evaluated through non-clinical testing and analysis, as formal clinical trials were not deemed necessary. The primary acceptance criterion was substantial equivalence to a predicate device (K063698 C-Las CO2 Laser System).

Study Details:

1. Sample size used for the test set and the data provenance: Not applicable. The study primarily involved non-clinical performance testing and analysis of the laser's power output and beam quality. There was no test set of patient data, nor was there any human subject data, retrospective or prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set is not relevant for this type of non-clinical device testing focused on physical parameters.

3. Adjudication method for the test set: Not applicable. There was no test set involving human judgment or interpretation.

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 CO2 laser, not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "study" was focused on the standalone performance of the laser system itself, specifically its power output and beam quality. It's an algorithm-only performance in the sense that it's the device operating independently of a human-in-the-loop for its basic function, but it's important to differentiate that it's not an AI algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" was established by engineering and physics principles, specifically measurements and analyses of laser power output and beam quality against established standards and comparison to the predicate device's measured parameters.

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.

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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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The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile Tip is indicated for the 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, 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 laryngoscopy. gastroscopy. colonoscopy, laparoscopy, 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 OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile Tip is an accessory for CO2 laser systems. It consists of a flexible fiber assembly that delivers CO2 laser energy that enables minimally invasive surgery. OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with low profile metal tip is supplied sterile and is intended for single procedure use in conjunction with the OmniGuide Laser Adapter.

The device consists of an optical fiber assembly. The main functional component of the fiber assembly is a photonic bandgap reflector lining its hollow core that reflects and thereby guides CO2 laser energy and a stainless steel waveguide distal tip. The fiber assembly is 1 to 2 m long and transmits at the CO2 laser emission wavelength of 10.6 um. The fiber has 14 mm long stainless steel tip that is used as a continuation of the waveguide, which enhances visualization in tight areas.

The provided 510(k) summary for the OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile Tip indicates that formal clinical trials were not deemed necessary. Instead, the device's performance was evaluated through non-clinical testing and comparison to predicate devices, claiming substantial equivalence.

Therefore, many of the specific questions about clinical study design, sample sizes, expert involvement, and ground truth establishment cannot be answered from this document as such a study was not conducted.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Inferred" Acceptance Criteria: The document states that performance characteristics were evaluated through "testing and analysis of laser power output and beam quality." It also mentions "energy transmission levels and beam quality" as major performance parameters that are "similar or equivalent to the characteristics of above mentioned legally marketed devices." This implies that the acceptance criteria for these parameters were met if they were found to be comparable to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. Formal clinical trials or test sets with human data were not conducted. The evaluation was based on non-clinical performance data (testing) and comparison to predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. Ground truth for a clinical test set was not established as no such test set was used.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was used that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No clinical study, MRMC or otherwise, was conducted.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical medical instrument (laser fiber), not an algorithm or AI. The performance evaluation was for the physical characteristics of the device.

7. Type of Ground Truth Used

The "ground truth" for the device's performance was established through non-clinical performance testing (laser power output and beam quality) and comparison to the characteristics and intended use of legally marketed predicate devices. No pathology, expert consensus, or outcomes data from a clinical setting were used as ground truth for this submission.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set or its associated ground truth establishment.

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The OmniGuide Sterile WaveGuide Adapter System is indicated for the 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, 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 laryngoscopy, gastroscopy, colonoscopy, laparoscopy, 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 Sterile WaveGuide Adapter System connects a hospitals CO2 laser to the OmniGuide WaveGuide Fibers. The additional filter and autoclave sterilization of the adapter and hose allows for use in sterile surgical procedures.

The output tube and gas hose will be sold non-sterile and the hospital will autoclave sterilize. The filter element may be provided as a gamma sterilized device (high Pressure option) or as a non sterile device for autoclave sterilization. The low pressure filter may be autoclave sterilized or provided sterile at the end users request.

The provided document describes a 510(k) premarket notification for the "OmniGuide Sterile WaveGuide Adapter System." The core of this submission is to claim "substantial equivalence" to a predicate device, not to prove clinical safety and effectiveness through extensive studies or acceptance criteria as would be typical for novel devices or AI/software.

Therefore, many of the requested categories are either not applicable or not explicitly detailed in this type of regulatory submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This section is not applicable in the traditional sense for this 510(k) submission. The submission does not define specific "acceptance criteria" for clinical performance (e.g., sensitivity, specificity, accuracy against a gold standard) because it relies on demonstrating substantial equivalence to a legally marketed predicate device.

Instead, the performance evaluation focused on demonstrating comparable technical characteristics to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable for clinical performance. The submission states, "Formal clinical trials were not deemed necessary as the device is using the same technology and intended use as the predicate device."

The testing performed was non-clinical (laser power output and beam quality), and details about the sample sizes for these engineering tests are not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No clinical test set requiring expert ground truth was established for this submission.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was established.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

No. A MRMC comparative effectiveness study was not performed. The device is a physical instrument, not an AI or software algorithm that would typically be evaluated in an MRMC study.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable. This device is a CO2 laser accessory, not an algorithm.

7. The Type of Ground Truth Used

Not applicable for clinical ground truth. The "ground truth" for the non-clinical performance evaluation appears to be established by engineering measurements against established laser performance standards and comparison to the predicate device's measured performance.

8. The Sample Size for the Training Set

Not applicable. This device is a physical instrument, not a machine learning model, so there is no concept of a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this device.

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The OmniGuide Mark III WaveGuide Fiber is indicated for the 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, 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 laryngoscopy, gastroscopy, colonoscopy, laparoscopy, 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 CO2 Mark III WaveGuide Fiber is an accessory for CO2 laser systems. It consists of a flexible fiber assembly that delivers CO2 laser energy that enables minimally invasive surgery. The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber is supplied sterile and is intended for single procedure use in conjunction with the OmniGuide Laser Adapter.

The device consists of an optical fiber assembly. The main functional component of the fiber assembly is a photonic bandgap reflector lining its hollow core that reflects and thereby guides CO2 laser energy. The fiber assembly is 1 to 2 m long and transmits at the CO2 laser emission wavelength of 10.6 um.

The provided text describes the OmniGuide Beam Path CO2 Mark III WaveGuide Fiber, but it does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria.

Instead, it states that:

• Clinical Performance Data: "Formal clinical trials were not deemed necessary as the device is using the same technology and intended use as predicate device."
• Non-clinical Performance Data: "The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber performance characteristics have been evaluated through testing and analysis of laser power output and beam quality. This type of testing complies with the respective section of the FDA Guidance on the Content and Organization of a Premarket Notification for a Medical Laser (1995) and is similar to the predicate device tests. The performance of OmniGuide Beam Path CO2 Mark III WaveGuide Fiber and related parameters of predicate device are comparable."
• Conclusion: "The intended use and major performance parameters (energy transmission levels and beam quality) of the OmniGuide Beam Path CO2 Mark III WaveGuide Fiber are similar or equivalent to the characteristics of above mentioned legally marketed device."

Based on this, I cannot fill out the requested table or provide details about a study proving specific acceptance criteria. The device's approval appears to be based on substantial equivalence to a predicate device (K050541), rather than meeting predefined acceptance criteria through a specific study with a test set, ground truth, or expert review.

Therefore, many of the requested fields cannot be answered from the provided text.

Here's an attempt to answer the questions based only on the provided information, highlighting what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test set sample size: Not applicable/Not provided. The document states "Formal clinical trials were not deemed necessary." Non-clinical testing focused on device characteristics and comparability to a predicate.
• Data provenance: Not applicable/Not provided in the context of a "test set" for a clinical study. The non-clinical data would be laboratory-generated.

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

• Not applicable/Not provided. No clinical "test set" requiring ground truth establishment by experts is mentioned.

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

• Not applicable/Not provided. No clinical "test set" requiring adjudication is mentioned.

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

• No. This is a medical device (CO2 laser fiber), not an AI-assisted diagnostic tool.

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

• Not applicable. This is a medical device, not an algorithm.

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

• Not applicable/Not provided, as no clinical study with a "ground truth" is described. The performance evaluation was primarily non-clinical, comparing technical specifications to a predicate.

8. The sample size for the training set

• Not applicable/Not provided. No machine learning training set is mentioned.

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

• Not applicable/Not provided. No machine learning training set or ground truth establishment is mentioned.

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