(246 days)
The pmd clean acne is intended for over-the-counter use to treat mild to moderate inflammatory acne.
The pmd clean acne adopts light emitting diodes (LED) in the blue (415nm ± 5nm) spectrum to irradiate on the face to realize its therapeutic effect. The pmd clean acne adopts handheld design, LEDs are contained in the blue light treatment window, and on its reverse side, the soft silicone bristols can be used to clean the face before the blue light treatment. The product is provided with internal battery and it can be charged by external adaptor. To prevent irradiation of LED lights to eyes during the treatment, pmd clean acne is equipped with goggles which blocks light energy from LEDs.
The PMD Clean Acne device (K230490) is intended for over-the-counter use to treat mild to moderate inflammatory acne. Its substantial equivalence was determined based on non-clinical studies and testing, demonstrating compliance with various safety and performance standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Standard Compliance) | Reported Device Performance (Compliance) |
|---|---|---|
| Electrical Safety | ANSI AAMI ES 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | Complies with ANSI AAMI ES 60601-1 |
| IEC 60601-1-11: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment | Complies with IEC 60601-1-11 | |
| IEC 60601-2-57: Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use | Complies with IEC 60601-2-57 | |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests | Complies with IEC 60601-1-2 |
| Photobiological Safety | IEC 62471: Photobiological safety of lamps and lamp systems | Complies with IEC 62471 |
| Battery Safety | IEC 62133-2: Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems | Complies with IEC 62133-2 |
| Biocompatibility (for skin-contacting materials) | ISO 10993-5: Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity | Complies with ISO 10993-5 |
| ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for skin sensitization | Complies with ISO 10993-10 | |
| ISO 10993-23: Biological evaluation of medical devices - Part 23: Tests for irritation | Complies with ISO 10993-23 | |
| Software Verification and Validation | Requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices" | Software verification and validation tests were conducted according to FDA guidance, demonstrating compliance. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical performance data using human subjects. The device's substantial equivalence determination relies on non-clinical testing against recognized standards. Therefore, there is no mention of a sample size for a test set of human subjects or their data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as the device's approval is based on non-clinical testing against established engineering and safety standards, not on clinical performance evaluated by experts against a ground truth for a test set of medical conditions.
4. Adjudication method for the test set
Not applicable, as there was no test set involving human subjects and expert adjudication.
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. The PMD Clean Acne is a standalone light therapy device, not an AI-assisted diagnostic or interpretive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the regulatory submission primarily relies on standalone non-clinical testing to demonstrate the device's safety and performance characteristics against established technical standards. This includes electrical safety, EMC, photobiological safety, battery safety, and biocompatibility. There is also specific mention of "Software verification and validation test" which would assess the algorithm/software performance independently.
7. The type of ground truth used
The "ground truth" for the non-clinical studies was the established technical and safety standards (e.g., IEC, ISO, ANSI AAMI standards) that the device was required to comply with. For biocompatibility, the ground truth was the standards for cytotoxicity, sensitization, and irritation. For software, the ground truth was the requirements outlined in FDA's guidance document for software in medical devices.
8. The sample size for the training set
Not applicable. This device does not appear to involve a machine learning or AI model that would require a "training set" of data in the typical sense. The software validation mentioned refers to standard software development and testing practices, not machine learning model training.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning model is indicated.
§ 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.