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The CO2 Laser Equipment is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

The subject device CO2 Laser Equipment is a carbon dioxide laser used in medical and aesthetic industry. The device emits laser energy at 10.6 um wavelength to induce human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. The CO2 Laser Equipment includes two models US800/US800N, the two models have same mechanism of action, structure, material, motherboard, software, principle and specification. The difference is appearance and size.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the CO2 Laser Equipment (K212611):

1. Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K192528) through performance and safety comparisons, rather than explicitly stating quantitative "acceptance criteria" for a novel device performance claim. The "acceptance criteria" are implied by the "Remark" column being "SAME" or "SE" (Substantially Equivalent) between the proposed and predicate devices.

For dimensions and weight, the proposed device differs but is deemed acceptable by complying with IEC 60601-1, indicating that this difference is not expected to adversely affect safety and effectiveness.

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

This document describes a premarket notification for a Class II medical device (CO2 Laser Equipment). The submission is based on demonstrating substantial equivalence to a previously cleared predicate device.

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. There is no specific "test set" of patient data in the way one would conduct a clinical trial for a novel device performance claim. The key assessment is against technical specifications and safety standards.
• Data Provenance: Not applicable for a typical clinical test set. The data provenance relates to the technical specifications, design documents, and results of non-clinical bench testing. The predicate device's prior clearance provides the established safety and effectiveness benchmark. The manufacturer is Beijing Globalipl Development Co., Ltd. (China).

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

Not applicable. This submission relies on demonstrating adherence to recognized consensus standards and equivalence to a predicate device, not on expert consensus to establish a "ground truth" for a diagnostic or predictive performance.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

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. The document explicitly states: "No clinical study is needed or included in this submission."

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

Not applicable. This device is a CO2 Laser Equipment, a physical surgical instrument, not an AI algorithm or software-only device. There is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the predicate device (K192528), along with compliance to recognized international safety and performance standards for medical electrical equipment and laser products (e.g., AAMI ES60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2). The submission argues that since the proposed device is technologically similar and meets the same or comparable performance standards, it is as safe and effective as the predicate.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that would have a "training set."

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

Not applicable. This is not an AI/machine learning device.

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