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The CO2 Laser, Model C-LAS is intended to be used by physicians for soft tissue cutting and tissue ablation in the following specialties:

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

The CO2 Laser System, Model C-LAS is an easily transported table top laser console made of mainly machined aluminum and optics for the transmission of reflection of CO2 laser wave lengths. It is a carbon dioxide laser which emits laser light at 10.6 micrometers and has a RF excited laser tube which produces an output power of about 30 watts. The laser is for used by physicians for cutting and coagulation at a wound during surgery. The physician uses the laser light on tissue via lenses and a focusing hand piece, or via a diamond scalpel which transmits the laser light onto the scalpel.

This document describes a 510(k) premarket notification for a CO2 laser system, Model C-LAS. The information provided heavily focuses on regulatory aspects and comparison to a predicate device, rather than detailed performance studies and acceptance criteria as would typically be seen for a new diagnostic AI device.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, or quantitative output power ranges with tolerances) for the device's cutting and coagulation abilities. Instead, it relies on substantial equivalence to a predicate device.

The "Performance Characteristics" section in the General Product Information (page 2) refers to "Software Test Procedures and Test Report," but the details of these tests and their criteria are not included in the provided text.

Based on the information given, the primary "acceptance criterion" appears to be Substantial Equivalence to the predicate device K875338: CHRYS™ MODEL MED-MAX.

Here's a table based on the similarities highlighted for substantial equivalence, which serves as a de-facto "performance" comparison in this context:

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

The document does not describe a "test set" in the context of clinical data for performance evaluation. It describes technological similarities to a predicate device. The "Software Test Procedures and Test Report" are mentioned (page 2), but their details, including sample sizes or data provenance, are not provided. Given the nature of a CO2 laser surgical instrument, "data provenance" related to patient data would not typically be applicable in the same way as for an AI diagnostic device.

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. This is a medical device (laser surgical instrument), not a diagnostic AI system requiring expert-established ground truth from clinical images or patient data. The "ground truth" for a laser system would be its physical output parameters meeting specifications.

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

Not applicable. No "test set" in the traditional sense of clinical data requiring expert adjudication is described.

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 is a standalone medical device (CO2 laser), not an AI system designed to assist human readers.

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

The device itself is a standalone laser surgical instrument. Its performance would be evaluated based on engineering specifications and safety, not an algorithm's diagnostic performance. The document indicates that "Software Test Procedures and Test Report" were performed (page 2), implying software testing for the embedded control system, but not clinical "standalone performance" in the AI sense.

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

For this type of device (a CO2 laser surgical instrument), the "ground truth" would be established through:

• Engineering specifications and measurements: Verifying output power, wavelength, mode, and other physical parameters meet design requirements.
• Performance testing: Demonstrating the device can perform its intended functions (cutting and coagulation on tissue models or in animal studies, though not explicitly detailed here).
• Safety testing: Ensuring compliance with electrical safety, laser safety standards, and electromagnetic compatibility.

The document refers to a "Certificate of Conformity" and "Safety Risk Analysis" (page 2), which would cover these aspects.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI system that requires a "training set" of data.

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

Not applicable.

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