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The ClearFlash AC2100 Cosmetic System is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

The ClearFlash AC2100 is a compact, handheld device that delivers a controlled pulse of thermal energy to the skin for treating dermatological disorders, specifically, mild to moderate inflammatory acne. An acne lesion is treated by applying the tip of the ClearFlash AC2100 device to the skin area and pressing a pulse activation button that releases a controlled amount of thermal energy into the skin. After the pulse is delivered to the skin the ClearFlash AC2100 device is removed from the acne lesion and the treatment is complete. The treated area on the skin can then be cleaned with an over-the-counter astringent. The ClearFlash AC2100 device is powered by a 9V battery.

The provided text describes the ClearFlash AC2100 Cosmetic System, a device for treating mild to moderate inflammatory acne. However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria.

The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than conducting extensive clinical efficacy trials typically associated with new medical device approvals.

Therefore, many of the requested
data points are not available in the provided document.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified.
• Data Provenance: The document only mentions "Laboratory bench top testing". No information on country of origin or whether it was retrospective or prospective is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

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

• MRMC Study: No. This device is a treatment system, not an AI-assisted diagnostic tool for human readers.

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

• Standalone Performance: The device is a standalone treatment device. Its performance is assessed through its direct application for acne treatment, not as an algorithm. The text states "Laboratory bench top testing demonstrated that the ClearFlash AC2100 device performed similarly to the predicate devices," indicating an evaluation of the device itself.

7. The type of ground truth used

• Type of Ground Truth: Not specified beyond "Laboratory bench top testing." For a treatment device, efficacy could be assessed by clinical improvement, but this document does not detail such evaluation. The substantial equivalence argument relies on comparing its mechanism to existing devices.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This document describes a physical medical device, not an AI algorithm that would typically require a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of an AI algorithm or a training set.

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