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Nideks UniPulse CO2 Laser System is intended for all cleared Coherent CO2 skin resurfacing applications.
Plastic Surgery and Dermatology: UniPulse CO2 Surgical Laser Systems are intended for skin resurfacing for the treatment of wrinkles, rhytids, furrows and acne scar revision.

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The provided text is related to a 510(k) clearance for the Nidek UniPulse CO2 Surgical Laser System. It is an administrative document confirming substantial equivalence to a predicate device, rather than a clinical study report describing acceptance criteria and device performance as typically expected for in-vitro diagnostic (IVD) devices or AI/ML-driven medical devices.

Therefore, most of the requested information regarding acceptance criteria, study details, expert consensus, and training/test set specifics for an AI/ML device is not applicable to this document. This document primarily focuses on regulatory clearance based on substantial equivalence to an already marketed device.

Here's a breakdown of what can be extracted and why other parts are not applicable:

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

• Not Applicable. The document does not describe specific performance-based acceptance criteria for the Nidek UniPulse CO2 Laser System in terms of classification metrics (e.g., sensitivity, specificity, AUC) or quantitative measurements. Instead, it relies on substantial equivalence to a predicate device. The "performance" assessment here is conceptual, relating to the device's ability to perform its intended function safely and effectively, similar to the predicate.

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. No explicit test set or clinical study data (in the sense of a controlled trial with a defined sample size for performance evaluation) is described. The clearance is based on the comparison to a predicate device, not on new clinical performance data from a specific test set.

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. Since there is no described test set or performance study, there is no mention of experts establishing ground truth for such a set.

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

• Not Applicable. No test set or corresponding adjudication method is discussed.

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 laser surgical system, not an AI-driven diagnostic or assistive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

• Not Applicable. This is not an algorithm or AI device.

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

• Not Applicable. As no specific performance study is detailed, no ground truth methodology is described. The "ground truth" for the clearance is essentially the established safety and efficacy profile of the predicate device.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device that requires a training set.

Summary of Relevant Information from the Document:

While most of the requested information for an AI/ML device is not applicable, here's what can be gleaned about the regulatory approach:

• Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
• Device Trade Name: UniPulse CO2 Laser System
• Device Common Name: CO2 Surgical Laser System
• Device Classification: Class II
• Performance Standards (Regulatory Compliance, not performance metrics): The laser systems comply with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable.
• Indications for Use: Plastic Surgery and Dermatology: UniPulse CO2 Surgical Laser Systems are intended for skin resurfacing for the treatment of wrinkles, rhytids, furrows, and acne scar revision.
• Basis for Clearance: Substantial equivalence to the Coherent CO2 laser system (the predicate device). The document states: "The Nidek CO2 system is substantially equivalent to Coherent's CO2 laser system. The risks and benefits of the Nidek UniPulse CO2 are comparable to the predicate device when used for similar clinical applications."

The clearance is granted because the Nidek UniPulse CO2 laser system is "substantially equivalent with respect to indications for use, materials, method of operation and physical construction" to the predicate device, thereby assuring safety and effectiveness. This is a common pathway for medical device clearance, especially for non-novel technologies like surgical lasers.

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