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The Theravant Acleara/TheraClear System is intended for the treatment of benign vascular and pigmented lesions; permanent hair reduction; and the treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris), in all skin types (Fitzpatrick I-VI).

The Theravant System is comprised of the following main components: Main console, Treatment Handpiece(s). The Theravant System is a portable tabletop system used to deliver intense pulsed light to the patient treatment site via a delivery handpiece utilizing vacuum technology. Intense pulsed light is emitted through the tip only when the tip is sealed against the selected patient treatment site. All emitted light is contained within the tip during treatment. A modification to the handpiece includes a needle accessory for use during the treatment of inflammatory acne lesions. The modified handpiece does not introduce any changes to the principles of operation as compared to the traditional handpiece. The modified handpiece uses vacuum to confine and stretch the target region, coupled with a fine gauge needle to facilitate the release of sebum from the pilosebaceous unit.

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and study details as requested. It's important to note that the provided text is a 510(k) Summary of Safety and Effectiveness, which is a summary document and often does not contain the granular detail of a full study report.

Based on the document, the device in question is a modification to an existing handpiece for the Theravant Acleara/TheraClear System. The modification involves adding a fine gauge needle to facilitate sebum release during acne treatment, complementing the existing vacuum technology. The primary claim is substantial equivalence to the predicate device (TheraClear System, K101415), arguing that the modification does not alter the fundamental principles of operation or introduce new risks and that the indications for use remain the same.

Therefore, the "acceptance criteria" and "study" are not presented in the typical format of a clinical trial proving specific performance metrics against a threshold for a new, de novo device. Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to the predicate device, particularly that the modification does not introduce new or different risks and that device operation and overall technical capabilities remain the same.

Acceptance Criteria and Reported Device Performance

Study Information Based on the Provided Document

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

• Sample Size for Test Set: Not specified in the 510(k) summary. The document mentions "Performance testing, including validation and verification testing, and risk analysis" but does not detail a clinical test set size or methodology.
• Data Provenance: Not specified.

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

• Not specified. The document does not describe the establishment of a ground truth for a clinical test set in the conventional sense, as it focuses on substantial equivalence based on technical characteristics and risk analysis.

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

• Not applicable/not specified. No clinical test set requiring adjudication is described.

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

• No MRMC study was performed or described. The device is a physical modification to a light therapy system for acne; it is not an AI-assisted diagnostic or therapeutic device evaluated with human readers.

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

• Not applicable. This is a medical device, not a software algorithm, so the concept of standalone performance for an algorithm does not apply directly. The "device performance" relies on its mechanical and energy delivery characteristics.

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

• Not explicitly described in terms of a clinical ground truth for a specific study. The "ground truth" for the current submission is effectively the established safety and effectiveness profile of the predicate device (TheraClear System K101415). The submission argues that the modified device's performance aligns with the predicate, based on technical and risk assessments rather than a new clinical ground truth for efficacy.

8. The sample size for the training set

• Not applicable/not specified. The device is not an AI/machine learning model, so there is no "training set."

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

• Not applicable. There is no training set for an AI/machine learning model. The "ground truth" for ensuring the modification's safety and effectiveness relies on established engineering principles, risk analysis, and performance testing data (as mentioned in Section VII, but not detailed).

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