(245 days)
The illuMask Acne Light Therapy Mask is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face.
The IlluMask Acne Light Therapy device uses known LED light therapy technology for the treatment of mild to moderate acne. A combination of red light (630mm) and blue light (445nm) is emitted. Users place the lightweight mask over the face press the On button on the controller button to start treatment. The device will automatically turn off after each treatment, and there is a total of 30 treatments.
Here's a breakdown of the acceptance criteria and the study that demonstrates the illuMask Acne Light Therapy Mask meets these criteria, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list "acceptance criteria" as a separate table. However, it presents the "Treatment Period Results" as evidence of the device's efficacy, which effectively serve as the performance benchmarks the device achieved.
| Performance Metric (Implicit Acceptance Criteria) | Reported Device Performance (Treatment Period Results) |
|---|---|
| Decrease in inflammatory acne lesions | 82.8% decrease |
| Decrease in non-inflammatory acne lesions | 71.2% decrease |
| Improvement in acne severity (FDA Global Acne Severity Scale) | 50% improvement (median movement of 2 points) |
| Reduction in total acne lesions (independent doctor evaluation, Week 4) | 36% reduction |
| Reduction in total acne lesions (independent doctor evaluation, Week 8) | 65.8% reduction |
| Patient compliance, satisfaction, and questionnaire grading | Highly favorable |
| Serious adverse events | None reported |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Clinical Study: 30 patients were initially enrolled for both the Washout and Treatment Periods. 27 of 30 subjects completed each period.
- Usability Study: 35 participants.
- Self-Selection Study: 47 randomly selected participants.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It describes it as an "IRB (Institutional Review Board) approved 12-week clinical study," suggesting a formal clinical investigation. The Self-Selection Study was conducted "in a typical retail / shopping mall environment," implying a US-based setting given the context of FDA submission. The Usability Study was conducted by an "independent testing group." The studies appear to be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Clinical Study:
- Principal Investigator: Conducted in-person clinical grading for acne counts and FDA Global Acne Severity Scale, and recorded adverse events. Qualifications are not explicitly detailed but implied to be a medical professional ("physician investigator").
- Independent Doctors: Two independent doctors conducted physician grading on the clinical photographs. Their specific qualifications (e.g., "dermatologist with 10 years of experience") are not provided, but they are described as "independent doctors."
4. Adjudication Method for the Test Set
- For the clinical photographs, "an average of the two independent doctor evaluations" was used to report the reduction in total acne lesions. This suggests a form of averaging or consensus between two independent readers. The phrase "adjudication" is not explicitly used, but the averaging of independent readings serves a similar purpose.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The provided summary does not describe a formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The study described is a clinical trial evaluating the device's efficacy in treating acne, not comparing diagnostic accuracy or efficiency with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The illuMask is a light therapy device, not an AI algorithm. Therefore, the concept of a "standalone algorithm" performance study is not applicable to this device. The clinical study assessed the device's direct therapeutic effect on patients.
7. The Type of Ground Truth Used
- Clinical Study Ground Truth: The ground truth for the clinical study was established through a combination of:
- Expert Clinical Assessment: In-person grading by the principal investigator using metrics like the FDA Global Acne Severity Scale and lesion counts.
- Expert Consensus on Photography: Two independent doctors evaluating standardized clinical photography in a blinded and randomized manner.
- Patient Self-Evaluation: Subjective assessments by patients on 14 attributes.
- Outcomes Data: Reduction in lesion counts and improvement in acne severity over time.
8. The Sample Size for the Training Set
The illuMask is a light therapy device, not a machine learning model. Therefore, there is no training set in the context of AI or algorithm development. The "training" in this context refers to the development and refinement of the physical device and its instructions, which was informed by the Usability and Self-Selection studies but not in the sense of an algorithm training set.
9. How the Ground Truth for the Training Set Was Established
As stated above, this device does not involve a machine learning algorithm, and thus, no ground truth for a training set was established. The Usability and Self-Selection Studies helped refine the device's instructions and packaging to ensure ease of use and understanding by the target audience, which could be considered an iterative design and development process rather than algorithmic training.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.