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The UltraLase Flexible CO2 Laser Waveguide is indicated for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, and ophthalmology, oral surveology, podiatry, gyneology, and urology procedures. It is used to deliver laser energy for incision, ablation, vaportzation, and coagulation of soft tissues.

The UltraLase Flexible CO2 Laser Waveguide can be used in open surgical procedures and endoscopic procedures.

The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached

The UltraLase Flexible CO2 Laser Waveguides are laser delivery systems for use in surgical procedures where a flexible delivery system would allow easier and more efficient delivery of laser energy to the targeted tissue.

The wavequide consists of a flexible silica capillary who's inside wall has been coated with a durable coating that is highly reflective at the intended wavelength of use. A fiber optic connector is attached to the proximal end of the waveguide and the waveguide is covered with a protective sleeve.

The UltraLase Flexible CO2 Laser Waveguide is designed to operate at 10.6um and has a broad enough transmission band to accommodate any laser operating in this region.

The laser energy is coupled into the waveguide using the correct focusing lens and travels down the waveguide by multiple bounces off the inner reflective surface, exiting to the tissue at the distal end.

The laser waveguides have either a 905 SMA connector or a 953 ST connector attached and can therefore be used with any CO2 Laser that is compatible with one of these connectors. The wavequides are 2 meters long.

It is recommended that a purge gas be used to flow a gas through the wavequide to keep the inner channel of the wavequide free of debris.

The waveguides delivery systems are supplied sterile for single use.

The provided text describes a 510(k) premarket notification for a medical device called the "UltraLase Flexible CO2 Laser Waveguide." This document focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new studies. Therefore, many of the requested categories for a typical medical device study that proves predefined acceptance criteria are not applicable in this context.

However, I can extract the information that is present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The non-clinical tests performed are listed, along with their acceptance criteria. The document states that the new device met these criteria, implying its performance aligns with them.

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

The document does not specify the sample sizes for the non-clinical tests. It refers to these as generic "tests." The data provenance is not explicitly stated, but these are non-clinical tests, meaning they were likely conducted in a laboratory setting by the manufacturer, Laser Engineering, in the US (Milford, MA). The tests are retrospective, as they were conducted to support a premarket notification for a device modified from a previously cleared one.

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

This information is not provided. For non-clinical tests like material biocompatibility or mechanical strength, "ground truth" would typically be defined by established international standards (e.g., ISO for ETO residual) or internal product specifications rather than expert consensus on a test set.

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

Not applicable. Adjudication methods are typically relevant for clinical studies or studies involving diagnostic interpretations by multiple human readers, not for non-clinical engineering or biological safety tests.

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. This device is a passive surgical tool (a laser waveguide), not an AI-powered diagnostic or assistive tool. No MRMC study was performed, and no AI component is mentioned.

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

Not applicable. This device is a physical instrument, not an algorithm. Therefore, no standalone algorithm-only performance testing was done.

7. The type of ground truth used

For the non-clinical tests:

• Performance Testing (Power Transmission): The ground truth is the engineering specification of greater than 70% transmission after sterilization.
• Biocompatibility (Intracutaneous, Muscle Implant, Systemic Toxicity): The ground truth is established by specific biological endpoints (e.g., "no evidence of irritation," "microscopic reaction not significant," "no mortality or systemic toxicity") as defined by relevant biocompatibility standards (e.g., ISO 10993 series).
• Sterilization & Residuals (Sterilization Validation, ETO Residual, Bioburden): The ground truth is defined by specific quantitative targets or compliance with standards (e.g., "sterility assurance level of 10^-6", "Meets requirements of ISO 10993-7", "Less than 100").
• Mechanical (Epoxy Strength, Package Integrity): The ground truth is based on engineering specifications (e.g., "15 Newtons for 15 seconds") or visual/physical inspection criteria.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

9. 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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Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The AcuPulse W system (recently cleared under K201663) is a scaled-down version of the cleared Lumenis Family of AcuPulse CO2Laser System. Delivery Devices and Accessories under K180597. The modified AcuPulse W, identically to its predicate (K201663) is comprised of the following main functional components:

• A Laser Console with a Free Beam Port to which an articulated arm is attached .
• . A footswitch to activate the laser treatment beam and allow the selected laser energy to be transmitted via the delivery device to the target location.
• . A variety of Free Beam Delivery Device and accessories
  The modified AcuPulse W and the cleared AcuPulse W (K201663) systems have the same proprietary software, which is embedded in the Main Controller, Peripheral Controller units and PC. Importantly, both systems use the same Software version, which was already validated, verified and submitted under K201663. Also, no changes to the Hardware were made to the svstem.
  The AcuPulse W is offered with previously cleared AcuPulse Handpieces/Tips that connect to the articulated arm or/and scanners for controlled delivery of laser energy to the target tissue. Among them, the cleared 90° Side-firing Handpiece (K201663) connects to the AcuScan 120 Microscanner through two adaptors (a Handpiece Adapter and Third Lens Adapter) for delivery of laser energy. The 90° Side-firing Handpiece is comprised of the following components:
• . Handpiece Adapter (cleared under K201663)
• . Tip:
  • Multiuse Standard Focus Tip (cleared under K201663) o
  • Multiuse Fine Focus Tip (cleared under (K201663) о
  • Disposable Standard Focus Tip (subject of this submission) o
  • Disposable Fine Focus Tip ((subject of this submission) o
• . Limiter ring (cleared under K201663)
  In this submission, Lumenis is introducing a disposable configuration of the 90° Side-firing Handpiece Tips in addition to the already cleared multiuse tips to respond to the increased market demand of disposable accessories for reducing the occurrence of treatment acquired infections. These 90° Side-firing Handpiece disposable tips are single use tips, packaged and EO sterilized, similarly to Lumenis devices previously cleared and used with the cleared AcuPulse Family of CO2Lasers (K100384 and K130164).

The provided document describes a 510(k) premarket notification for a medical device, specifically the Lumenis AcuPulse W CO2 Laser System, Delivery Devices, and Accessories. This document is a regulatory submission to the FDA, asserting substantial equivalence to a legally marketed predicate device.

It does not contain information about the performance of an AI/algorithm-driven device, nor does it provide acceptance criteria or study results for such a device. The modifications detailed in this 510(k) are related to the introduction of disposable tips for a laser system, which is a hardware change, not an AI software change.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document discusses design verification processes for the modified laser system and its disposable tips, which include:

• Risk analysis per ISO 14971.
• Electrical safety testing to IEC 60601-1.
• Performance verification and validation to evaluate that the 90° Side-firing Handpiece with the new disposable configuration of Tips performs according to its specifications.
• EO sterilization and Shelf-life validation activities (ISO 11607, ISO 11135-1, ISO 10993).
• Biocompatibility evaluation (ISO 10993).

The key takeaway from the document regarding "performance" is:

"Test results indicated that the AcuPulse W with the 90° Side-firing Handpiece equipped with the new configuration of disposable tips performs in accordance with its requirements and specifications similarly to its predicate device."

This statement confirms that the new disposable tips meet functional and safety requirements comparable to the existing multiuse tips, ensuring substantial equivalence to the predicate device. However, it does not provide specific quantitative acceptance criteria or detailed study results generally associated with AI/ML device performance.

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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 Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is indicated for the vaporization, incision, excision, ablation or photocoagulation of soft tissue in the surgical specialties of: ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry.

The intended use of the Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is for the performance of specific surgical applications in the surgical specialties of ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry as follows:

Dermatology
Podiatry
Otolaryngology (ENT)
Gynecology and GYN Laparoscopy Indications
Neurosurgery Indications
Orthopedic Indication
General and Thoracic Surgery
Dental and Oral Surgery

The Lumenis AcuPulse Family of CO2 Laser Systems are advanced computer-controlled Carbon Dioxide (CO2) laser systems based on a DC-excited sealed-off CO2 laser tube, that depending on their configuration, can provide up to 30 or 40-Watts on tissue. The AcuPulse Family of CO2 Lasers includes the following system models:

• The AcuPulse (previously called AcuPulse 30/40ST) system that incorporates a Free Beam Port only.
• The AcuPulse 40WG System that incorporates a Fiber Port only.
• The AcuPulse DUO, a new member of the family, which incorporates both a Free Beam Port and a Fiber Port.

The AcuPulse DUO laser added to the AcuPulse family represents a combination of the previously cleared AcuPulse 30/40ST and AcuPulse 40WG lasers. The minor differences in technological characteristics between the AcuPulse DUO and the predicate systems exist to facilitate this integration (mechanical and software adaptations that enable having two ports in one System) and do not affect any of the device's functionalities or performance specifications. The AcuPulse DUO System, with the incorporation of both the Free Beam and the Fiber port in one console, shares the same underlying technology and fundamental functionality as the previously cleared AcuPulse Family of CO2 Laser Systems. All of these laser systems are comprised of the following main functional components:

• a Laser Console with a port: a Free Beam Port to which an articulated arm is attached (AcuPulse model), a Fiber Port to which a Fiber is attached (AcuPulse 40WG), or both the Free Beam Port and Fiber Port (AcuPulse DUO)
• a Footswitch
• Various Free Beam Delivery Device and accessories (AcuPulse and AcuPulse DUO compatible) or Fiber Delivery Devices and accessories (AcuPulse 40WG and AcuPulse DUO compatible).

The AcuPulse DUO, similarly to the previously cleared AcuPulse and AcuPulse 40WG, is operated and controlled via proprietary software embedded in the Main controller. Peripheral controller units and PC.

The Delivery Devices and accessories, in accordance with their type and compatibility (e.g., Fiber Port or Free Beam port) are shared by all AcuPulse Laser Systems. The Free Beam Deliverv Devices and accessories include: Endoscopes/Laparoscopy accessories, Handpieces/Tips, Micromanipulators, and Scanners with accessories and adaptors. The Fibers that may be used with the Fiber Port are supplied with various handpieces (through which the Fiber may be inserted for more convenient handling during surgical procedures) and additional accessories for Fiber maintenance and handling.

The provided text is a 510(k) summary for the Lumenis AcuPulse Family of CO2 Laser Systems. It describes the device, its intended use, and indicates that performance testing was conducted. However, it does not contain detailed information regarding specific acceptance criteria, reported device performance in those criteria, sample sizes, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone algorithm studies) in the manner typically associated with clinical performance evaluation for AI/ML devices.

The document focuses on demonstrating substantial equivalence to a predicate device (AcuPulse 30/40ST and AcuPulse 40WG CO2 Lasers, K100415) based on:

• Intended use and indications for use: These are stated to be the same as the predicate devices.
• Principles of operation: Stated to be the same.
• Technological characteristics: Stated to be "nearly identical," with "minor differences" related to combining capabilities of previously cleared devices.
• Performance data: General statements about risk analysis, electrical and laser safety, electromagnetic compatibility testing, software verification and validation, and system testing to ensure compliance with specifications.

Given these limitations, I cannot provide a table of acceptance criteria, reported device performance, or details about clinical study specifics such as sample sizes, data provenance, expert ground truth, adjudication methods, or MRMC/standalone study results for AI.

Here's a breakdown of what can be extracted from the document based on your request, and where information is explicitly not present:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative acceptance criteria (e.g., specific thresholds for laser power output, pulse duration accuracy, beam quality, or safety interlock response times) are not detailed, nor are the precise numerical results of the performance tests against such criteria. The document states "performance in compliance with their specifications and requirements" but does not list those specifications.

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

• Sample Size for Test Set: Not specified. The performance testing mentions "system testing" but does not refer to a clinical "test set" in the context of diagnostic or predictive performance metrics. The evaluation focuses on device functionality and safety.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not specified. The tests appear to be engineering/technical verification and validation rather than clinical data studies.

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

• Number of Experts: Not applicable/Not specified. Ground truth in the context of clinical interpretation, as would be relevant for AI/ML devices, is not mentioned. The testing described relates to the laser system's technical specifications and safety.
• Qualifications of Experts: Not applicable/Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not specified. This information is relevant for studies involving human interpretation or challenging cases, which is not the type of study described here.

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

• MRMC Study: No. The document does not mention any clinical comparative effectiveness study involving human readers, with or without AI assistance. The device is a surgical laser system, not an AI diagnostic tool that would typically be evaluated with MRMC studies.
• Effect Size of Human Readers with AI vs. without AI: Not applicable, as no such study was conducted or reported.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No. This device is a physical CO2 laser system, not an AI algorithm intended for standalone performance evaluation against a diagnostic problem. Performance testing was related to the physical and software functionality of the laser itself.

7. Type of Ground Truth Used

• Type of Ground Truth: For the performance tests conducted (risk analysis, electrical/laser safety, EM compatibility, software V&V, system testing), the "ground truth" would be the engineering specifications, regulatory standards (e.g., IEC standards), and the device's design requirements. There is no mention of clinical ground truth (e.g., pathology, outcomes data, or expert consensus) as would be relevant for a diagnostic or prognostic device.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. This concept is relevant for AI/ML models that learn from data. The document describes a traditional medical device (laser system) with embedded proprietary software, but not an AI/ML system with a "training set."

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

• How Ground Truth Was Established: Not applicable/Not specified. As there's no mention of an AI training set, this information is not relevant to the provided document.

In summary: The provided 510(k) summary is for a traditional surgical laser system. The "performance data" section focuses on engineering verification and validation against regulatory standards and internal specifications to demonstrate safety and effectiveness for substantial equivalence, rather than clinical performance evaluation of an AI/ML algorithm against a diagnostic ground truth. Therefore, many of the specific details requested regarding AI/ML study design are not present in this document.

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The UltraLase Flexible CO2Laser Waveguide is indicated for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, and ophthaimology, oral surgery, oto-rhino-laryngology, podiatry, gynecology and urology procedures. It is used to deliver laser energy for incision, excision, ablation, vaporization, and coagulation of soft tissues.

The UltraLase Flexible CO2Laser Waveguide can be used in open surgical procedures and endoscopic procedures.

The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.

The UltraLase Flexible CO2 Laser Waveguide is a laser delivery system for use in surgical procedures where a flexible delivery system would allow easier and more efficient delivery of laser energy to the targeted tissue. The waveguide consists of a flexible silica capillary whose inside wall has been coated with a durable coating that is highly reflective at the intended wavelength of use. A fiber optic connector is attached to the proximal end of the waveguide and the waveguide is covered with a plastic sleeve for protection. The UltraLase Flexible CO2 Laser Waveguide is supplied with a single use handpiece attached or without a handpiece so it can be used with various reusable handpieces such as the TTI Medical ACCU-Beam Fiberoptic Handpieces.

The UltraLase Flexible CO2 Laser Waveguide is designed to operate at 10.6µm and has a broad enough transmission band to accommodate any laser operating in this region.

The laser energy is coupled into the waveguide using the supplied focusing lens and travels down the waveguide by multiple bounces off the inner reflective surface, exiting to the tissue at the distal end.

The UltraLase Flexible CO2 Laser Waveguides come with either a 905 SMA connector or a 953 ST connector and are therefore can be used with any CO2 Laser that is compatible with one of these connectors. The waveguide is supplied in several diameters and lengths as shown in the following chart.

It is recommended that a purge gas system using an inert gas such as helium be used to force an inert gas through the waveguide for cooling and to keep the inner channel of the waveguide free of debris.

The waveguides delivery systems are supplied sterile for single use.

Here's an analysis of the provided text regarding the UltraLase Flexible CO2 Laser Waveguide's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices. It largely describes the device's technical specifications and intended uses, and then states that it was "bench tested" for transmission bandwidth and percent transmission. It does not present specific numerical acceptance criteria or detailed results from these bench tests beyond confirming they were performed. The "reported device performance" in the table above is thus an inference that the device met internal criteria for its design specifications, rather than a direct report of specific performance values against pre-defined numerical objective criteria.

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

The document does not explicitly state a sample size for a dedicated "test set" in the context of clinical trials or specific performance verification. The performance testing mentioned ("bench tested to establish transmission bandwidth, and percent transmission") refers to laboratory/engineering testing rather than a clinical study with a distinct patient test set.

• Test Set Sample Size: Not specified for clinical or comparative studies. For bench testing, the sample size of waveguides tested is not mentioned.
• Data Provenance: The bench testing is implied to be internal to Laser Engineering (the applicant). There is no mention of country of origin for any data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for this type of device, extensive clinical data from human subjects is often not required if substantial equivalence can be demonstrated through technological characteristics and engineering testing.

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

This information is not applicable or not provided in the document. The submission is a 510(k) for a CO2 laser waveguide, which is a device for energy delivery. The performance testing described is engineering-focused (transmission bandwidth, percent transmission). There is no mention of a "test set" that would require expert-established ground truth in a diagnostic or interpretive context.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. As there's no mention of a clinical "test set" requiring expert interpretation or diagnosis, no adjudication method would be in play.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this document. The submission focuses on demonstrating substantial equivalence through technological characteristics and bench testing, not on comparative effectiveness with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable. The UltraLase Flexible CO2 Laser Waveguide is a physical medical device (a fiber optic waveguide) used to deliver laser energy, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the described "bench testing to establish transmission bandwidth, and percent transmission," the "ground truth" would be established by physical measurements and engineering standards/specifications for laser light transmission through a fiber optic waveguide. It is not expert consensus, pathology, or outcomes data, as those are relevant for diagnostic or treatment efficacy studies.

8. The Sample Size for the Training Set

This information is not applicable or not provided. As the device is not an AI/ML algorithm or a diagnostic tool that learns from data, there is no "training set."

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

This information is not applicable or not provided. As there is no "training set," there is no ground truth establishment for one.

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