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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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The Clinicon UHP/disposable tip is/are indicated for use in general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-mino-laryngology, podiatry, gynecology, and urology procedures for incision, excision, vaporization, ablation, coagulation, cauterization of soft tissue.

The Clinicon UHP/disposable tip indications are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.

The Universal WaveGuide Handpiece comes in two designs, one that accepts 1.5 mm O.D. size fiber tips and one that accepts 2.5 mm O.D. size fiber tips. The 1.5 mm handpiece is used with the Free Beam and Flexible fiber tips. The 2.5 mm handpiece is used with the rigid fiber tips.

The collet component determines the O.D. size fibers that can be inserted into the handpiece. The nozzle and tip lock collet secures the fiber and prevents twisting of the fiber tip. The hand piece is attached to the Clinicon WaveGuide Platform by the FSMA connector at the distal end of the waveguide.

The Fiber Tips are made of the same proprietary waveguide fiber as the Clinicon WaveGuide Platform, described in the premarket notification, K992472, SUREGUIDE CO2 Laser Beam Delivery System.

The waveguide fiber is inserted into a straight or curved stainless steel sheath for the 2.5 mm O.D. rigid fiber tips or into a Teflon tube for the 1.5 mm O.D. flexible fiber tips.

The fiber tips, both rigid and flexible are of various lengths for use in various surgical procedures. The rigid fiber tips are also of various degrees of curvature and certain tips may have a contact probe tip cover made of Teflon.

The fiber tips are disposable, single-use devices, and both the rigid and flexible fiber tips have a section of colored polyethylene at the distal end of the fiber cable that acts as a depth gauge to assure the fiber is completely seated in the handpiece. The colored polyethylene also acts as a sterilizer indicator that will render the tips unusable if they are re-sterilized by distorting the polyethylene and preventing the fiber from being inserted into the handpiece.

The provided text describes a 510(k) premarket notification for the Clinicon Universal WaveGuide Handpiece and Fiber Tips. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria. Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of AI/ML performance metrics, is not available in the provided text.

Here's an analysis of why the requested information cannot be found and what is present in the document:

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

• Not Available: The submission is for a medical device (CO2 Laser Powered Surgical Instrument), not an AI/ML diagnostic or predictive device. The FDA 510(k) process for such devices typically focuses on comparing the new device's technological characteristics, intended use, and safety/effectiveness to a legally marketed predicate device. This usually doesn't involve defining specific performance metrics (like sensitivity, specificity, AUC) and comparing them against pre-defined acceptance criteria in a quantitative table.

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

• Not Applicable/Not Available: Since no formal performance study with a test set (in the context of AI/ML) is described, these details are not present. The submission focuses on substantial equivalence through design and material comparison.

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):

• Not Applicable/Not Available: This refers to the establishment of ground truth for a diagnostic or predictive algorithm. As this is a surgical instrument, such expert-driven ground truth establishment for a test set is irrelevant and not mentioned.

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

• Not Applicable/Not Available: Similar to the above, adjudication methods are used to resolve discrepancies in expert-labeled ground truth for diagnostic studies. This is not relevant to a surgical instrument.

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/Not Available: MRMC studies are specific to evaluating human reader performance with and without AI assistance for diagnostic tasks. This device is a surgical tool, not an AI diagnostic tool.

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

• Not Applicable/Not Available: This refers to standalone AI algorithm performance. This device is a physical surgical instrument.

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

• Not Applicable/Not Available: The concept of "ground truth" as used in AI/ML performance validation does not apply to this surgical device. The "truth" in this context would be aspects like material properties, laser energy delivery capabilities, and sterility, which are assessed through engineering tests and regulatory compliance rather than "ground truth" derived from expert consensus or pathology data.

8. The sample size for the training set:

• Not Applicable/Not Available: No training set, in the AI/ML sense, is involved.

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

• Not Applicable/Not Available: No training set or ground truth establishment for it is relevant here.

What the document does describe (relevant to substantial equivalence):

The document provides information comparing the new device to existing predicate devices, focusing on:

• Intended Use: The device is intended to deliver carbon dioxide laser energy for the incision, excision, vaporization, ablation, coagulation or cauterization of soft tissue, similar to the predicate devices.
• Technological Characteristics:
  • The Clinicon Universal WaveGuide Handpieces have the "same technological characteristics" as Luxar handpieces (K903079).
  • The Clinicon Fiber Tips have the "same technological characteristics" as the Clinicon Sureguide CO2 Laser Beam Delivery System (K992472).
• Design Features: Descriptions of two handpiece designs (1.5mm and 2.5mm O.D. fiber tips), collet component, nozzle and tip lock collet, FSMA connector. Description of fiber tips (rigid/flexible, various lengths, curvature, Teflon contact probe tip cover), disposable nature, colored polyethylene depth gauge and sterilizer indicator.

Conclusion:

This 510(k) submission is for a conventional surgical instrument and relies on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety/performance profiles, rather than presenting a statistical performance study against explicit acceptance criteria in the manner requested for an AI/ML device.

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