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The Acne Light Therapy Wand is indicated to treat mild to moderate inflammatory acne.

The Acne Light Therapy Wand uses known LED light therapy technology for the treatment of acne. A combination of blue light and red light is emitted. The Acne Light Therapy Wand device does not emit any ultraviolet (UV) light. UV light is defined as light with the range of 100-400nm. To use the Acne Light Therapy Wand device, users place the device over the treatment area and press the "On" button on the device to start treatment. The device will automatically turn off after each treatment cycle.

The provided text is a 510(k) premarket notification for a medical device called the "Acne Light Therapy Wand." It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving that the device meets specific acceptance criteria in terms of clinical performance.

Based on the document, here's an analysis of what is and isn't available for your request:

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

The document does not provide a table of clinical acceptance criteria for the device's performance in treating acne, nor does it report clinical performance data against such criteria. The "Performance Data" in Table 1 (page 5) simply states: "Complies with applicable performance specifications and usability requirements." This refers to non-clinical performance (e.g., electrical safety, usability), not clinical efficacy.

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

No clinical testing was conducted for the Acne Light Therapy Wand (page 6, Section 10). Therefore, there is no clinical test set for which to determine sample size or data provenance.

A "Self Selection and Usability Study" was conducted (page 6, Section 9) with laypersons, but details on the sample size for this study are not provided. This was a non-clinical study focused on usability and understanding of instructions.

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, as no clinical testing was performed to establish ground truth for clinical efficacy.

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

Not applicable, as no clinical testing was performed.

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 device is an acne light therapy wand, not an AI-assisted diagnostic or interpretive device.

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

Not applicable. This device is not an algorithm.

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

Not applicable for clinical efficacy. For the usability study, the "ground truth" would be the ease of use and understanding by laypersons, assessed through direct interaction and feedback, but the method for establishing this "ground truth" is not detailed beyond stating it "demonstrated that the Acne Light Therapy Wand is an easy to use device and the packaging and labeling are appropriate for and easily understood by the layperson."

8. The sample size for the training set

Not applicable, as no algorithm or machine learning model is involved, and no clinical training set was used.

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

Not applicable, as no training set was used.

Summary of what the document does provide:

The 510(k) submission argues for substantial equivalence based on:

• Intended Use: The same as predicate devices (treatment of mild to moderate inflammatory acne) (page 4, Section 7).
• Technological Characteristics: Comparison of physical design, materials, wavelengths, dose rates, and electrical power with predicate devices (Table 1, pages 5-6).
• Non-Clinical Testing:
  • Conformity to international standards for electrical safety (IEC 60601-1 3rd edition, IEC 60601-1-2) and photobiological safety (IEC 62471).
  • A "Self Selection and Usability Study" with laypersons, demonstrating ease of use and understandable labeling (page 6, Section 9).

The core of this submission is the argument that because the device is substantially equivalent to legally marketed predicate devices, clinical testing (and thus, specific acceptance criteria for clinical performance) was not required for clearance. The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical testing and the comparison to predicate devices, asserting that these are sufficient to demonstrate safety and effectiveness without new clinical data.

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