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For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia

NOABLE LASER is a laser surgical instrument used during treatment where the laser 1450nm wavelength generated from the diode laser module. It can be used for incision, destruction and removal of skin tissue by illuminating a 1450 nm wavelength laser on the skin tissue.

Based on state-of-the-art diode laser technology, the system offers many advantages, including the combination of the effective wavelengths, excellent pulse characteristics, and unique dynamic cooling device (DCD) and compact instrument. Laser is sent out through the diode laser module equipped inside the Main body to oscillate the laser and the user uses the touch LCD in the Main body and hand-piece to set the output parameters while controlling laser radiation through the foot switch and hand-piece switch. At this point, a coolant is sprayed from the end of the hand- piece to protect skin from the heat generated by the radiated laser, resulting in a reduction in skin irritation and pain.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "NOABLE LASER." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report as would be found in a clinical trial. As such, information regarding clinical effectiveness directly linked to numerical acceptance criteria for specific medical conditions is not present.

However, based on the non-clinical testing section, we can infer some "acceptance criteria" related to device performance, safety, and equivalence to established standards.

Here's a breakdown of the information requested, based on the provided text:

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

Since this is a 510(k) submission and not a clinical study report with specific performance metrics for clinical efficacy, the "acceptance criteria" are primarily based on meeting recognized industry standards and demonstrating similar technological characteristics to the predicate device. Direct numerical performance metrics for clinical outcomes (e.g., reduction in acne lesion count) are not provided in this document.

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 primarily describes non-clinical testing. For the biocompatibility tests (cytotoxicity, sensitization, irritation) and the accuracy tests, the "sample size" would refer to the number of test materials, cells, or animals used. However, this specific sample size is not explicitly stated in the provided text.

• Data Provenance: The document does not specify the country of origin for the non-clinical testing data. The manufacturer is based in South Korea, but the testing could have been conducted anywhere. The testing is non-clinical, implying a prospective test design for evaluation against standards.

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)

This is not applicable as the document describes non-clinical engineering and safety testing, not human-read clinical data. "Ground truth" in this context would be defined by the technical standards themselves (e.g., IEC, ISO) and the measurements obtained from the device.

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

This is not applicable as the document describes non-clinical testing and not a study requiring reader adjudication of clinical outcomes.

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

This is not applicable. The "NOABLE LASER" is a laser surgical instrument, described as an energy-based device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

This is not applicable. The device is a physical laser instrument, not an algorithm. Its operation involves a human operator (physician/dermatologist).

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

For the non-clinical tests described:

• Biocompatibility: The "ground truth" is defined by the toxicological responses of cells or tissues as measured against the criteria established in ISO 10993 standards.
• Electrical Safety, EMC, Laser Safety, Particular Performance: The "ground truth" is adherence to the specifications and limits defined by the IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22).
• Accuracy Testing: The "ground truth" is the specified nominal values and their acceptable tolerance ranges for energy output and laser radiation range.

8. The sample size for the training set

This is not applicable as the device is a laser surgical instrument and not an AI/machine learning algorithm requiring a "training set."

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

This is not applicable for the same reason as above.

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