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The CO2 Laser Therapy System is used for body soft tissue vaporization and coagulation in dermatology and plastic surgery, general surgery, gynecology.

The CO2 Laser Therapy Systems generate a 10,600nm wavelength, which is absorbed by water in the tissue. The laser energy heats up the water until it reaches a boiling point causing the evaporation of the affected tissue. Some heat is absorbed by tissue adjacent to the ablated target area, causing tissue coagulation which induces hemostasis (the cessation of bleeding) as well as thermal stimulation of deep skin layers, which induces fibroblast stimulation and neocollagenesis (the formation of new collagen).

I'm sorry, but the provided text describes a medical device called "CO2 Laser Therapy System" and its FDA 510(k) clearance application. It details the device's indications for use, technological characteristics, and comparison to predicate devices, along with non-clinical testing performed to meet electrical safety and electromagnetic compatibility standards.

However, the document explicitly states in section "VIII Clinical Testing" that "It is not applicable." This means that no clinical studies, which would typically involve testing the device's performance against defined acceptance criteria on a test set with ground truth, were conducted or included in this submission for the purpose of demonstrating substantial equivalence.

Therefore, I cannot provide the information requested regarding acceptance criteria, device performance, sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment, as this type of information is not present in the provided text. The FDA clearance was based on substantial equivalence to predicate devices and non-clinical performance testing.

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The equipment is used for human tissue vaporization in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing.

The subject device, CO2 Laser System (Model: GP900F) mainly consist of console, articulated arm and a foot switch. CO2 laser wavelength is 10600nm, which is used to gasify the skin tissue based on the principle of the theory selective photothermolysis. The water in skin absorbs laser energy and evaporates. By setting up the suitable energy and other parameters on skin tissue, the device can be used for human tissue vaporization and coagulation as well as for the treatment of wrinkles and skin resurfacing.

This document describes the CO2 Laser System (Model: GP900F) and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria, device performance metrics (e.g., accuracy, sensitivity, specificity), or a study designed to prove the device meets such criteria in terms of clinical effectiveness.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through comparisons of technological characteristics, safety standards, and non-clinical testing. This type of submission (510(k)) generally does not require clinical effectiveness studies in the same way a PMA (Premarket Approval) would.

Therefore, many of the requested details cannot be extracted from the provided text. I will answer the questions based on the information that is available.

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

Based on the provided text, specific acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity) and corresponding device performance metrics are not detailed. The acceptance criteria are implicit in the demonstration of substantial equivalence to predicate devices and compliance with safety and performance standards.

The "performance" described relates to adherence to safety standards and the ability to deliver set laser energy parameters within specifications, not clinical outcomes or diagnostic accuracy.

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

Not applicable/Not provided. This document details a 510(k) submission, which typically relies on non-clinical testing and comparison to predicate devices, rather than clinical studies with test sets in the context of diagnostic or treatment accuracy. The "test set" here refers to the units of the device itself and materials used for engineering and biocompatibility tests.

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 provided. Ground truth, in the context of clinical outcomes or diagnostic accuracy, is not discussed. The "truth" for this submission is compliance with established device safety and performance standards and technological equivalence to predicate devices. Experts involved would be engineers, physicists, and toxicologists related to the conducted tests.

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

Not applicable/Not provided. This refers to methods for resolving discrepancies in clinical assessments, which is not relevant to this type of device submission presented here.

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 provided. This device is a CO2 Laser System, a surgical instrument. It is not an AI-assisted diagnostic or interpretation device that would typically involve human "readers" or MRMC studies.

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

Not applicable/Not provided. The CO2 Laser System is a surgical instrument operated by a human, not an algorithm.

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

The "ground truth" for this 510(k) submission is primarily established through:

• Compliance with recognized international standards: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, and FDA guidance for software.
• Bench performance testing: Demonstrating that the device physically delivers its intended laser energy parameters as specified.
• Comparison to predicate devices: Establishing that the technological characteristics and indications for use are substantially equivalent to devices already cleared by the FDA.

8. The sample size for the training set

Not applicable/Not provided. There is no mention of a "training set" in the context of machine learning or AI models, as this is a physical medical device. If "training set" refers to manufacturing processes or quality control, that information is not detailed here.

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

Not applicable/Not provided. As there is no "training set" for an AI or machine learning model, the establishment of ground truth in that context is not relevant.

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