(116 days)
The Pulsaderm Acne Mask 28 and Pulsaderm Acne Mask 37 are intended for over the counter use for the treatment of mild to moderate acne.
Pulsaderm Acne Mask 28 and Pulsaderm Acne Mask 37 are class II Medical Devices that use Light Emitting Diodes to apply low power monochromatic and non-coherent light in the red and blue range, to treat mild to moderate acne. The devices are powered by Ni-MH rechargeable batteries.
The provided document is a 510(k) summary for the Pulsaderm Acne Mask 28 and 37. It describes the device, its intended use, and its substantial equivalence to a predicate device (Illumask Acne Light Therapy System, K123999). However, it does not contain information related to specific acceptance criteria for device performance in terms of clinical effectiveness (e.g., reduction in acne lesions) nor a study proving the device meets such criteria.
The "Performance Data" section primarily addresses compliance with electrical, electromagnetic compatibility, photobiological safety, and biocompatibility standards, as well as a lay-user study for usability and self-selection. It does not provide data on the clinical efficacy of the device in treating acne.
Therefore, many of the requested details cannot be extracted from this document, as the focus is on demonstrating substantial equivalence through technical characteristics and safety, rather than presenting clinical trial results against pre-defined efficacy acceptance criteria.
Here's an attempt to answer the questions based only on the provided text, with clear indications where information is not available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., a specific percentage reduction in acne lesions) for the Pulsaderm Acne Mask. The "acceptance" in this context refers to demonstrating substantial equivalence to the predicate device and compliance with safety standards and design specifications.
- Reported Device Performance: The document reports on compliance with various safety standards and the results of a lay-user study for usability. It does not report clinical performance metrics for treating acne.
| Acceptance Criteria Category | Acceptance Criteria (Not Explicitly Stated for Clinical Efficacy) | Reported Device Performance |
|---|---|---|
| Clinical Efficacy | Not explicitly stated in terms of a quantitative clinical outcome (e.g., X% reduction in acne lesions). Implied acceptance is substantial equivalence to predicate which is "indicated to treat mild to moderate acne." | No clinical efficacy data (e.g., reduction in acne) is reported in this document. The device shares similar technical characteristics (wavelength, energy, treatment protocol) with the predicate device, which is indicated for "mild to moderate acne." |
| Electrical Safety | Compliance with IEC 60601-1 | "tested and found in conformance with test standards: IEC 60601-1" |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | "tested and found in conformance with test standards: IEC 60601-1-2" |
| Photobiological Safety | Compliance with IEC 62471 | "tested and found in conformance with test standards: IEC 62471" |
| Biocompatibility | Compliance with ISO 10993 | "Biocompatibility testing to ISO 10993." |
| Usability/Self-Selection | Lay users can read labeling, self-assess benefits, and use the device as intended. | "Study data was collected and demonstrated that the intended users of the device could successfully follow the instructions and use the device as intended. The performance data supplied in this 510(k) demonstrated that the majority of lay users were able to properly self-select themselves... and properly use the device by reading instructions in the user manual without any assistance." |
| Quality Management System | Conforming to ISO 14971 | "designed and developed under a quality management system conforming to ISO 14971." |
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 the lay-user study, the specific number of participants is not provided. It refers to "the majority of lay users."
- Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective). However, the study was conducted with IRB approval and oversight, implying a prospective study design for the usability testing.
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 / Not Provided: This question is typically relevant for studies involving expert review of objective data (e.g., medical images). The lay-user study described here focused on user comprehension and device operation, not expert-adjudicated clinical outcomes. There is no mention of experts establishing a "ground truth" in the clinical sense within this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: As in point 3, this refers to expert review processes, which are not described for the studies mentioned in this document.
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: The document does not describe an MRMC comparative effectiveness study, nor does it involve AI assistance for human readers. This device is a light therapy mask, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This refers to the performance of an algorithm without human intervention, typically in AI/diagnostic device contexts. The Pulsaderm Acne Mask is a physical medical device for treatment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the lay-user study, the "ground truth" was whether users could successfully read instructions, self-select for use, and operate the device as intended. This was assessed by the study design and likely recorded through observations, questionnaires, or task completion metrics, overseen by an IRB. It does not involve expert consensus, pathology, or clinical outcomes data in the traditional sense for effectiveness.
- For clinical efficacy (treating acne), no such ground truth or study is described in this document. The claim of "treatment of mild to moderate acne" is based on substantial equivalence to the predicate device, which presumably demonstrated efficacy in its own submission.
8. The sample size for the training set
- Not Applicable / Not Provided: This question usually applies to machine learning models. No training set is mentioned as this is a physical light therapy device.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: As in point 8, this is not relevant to the information provided about the Pulsaderm Acne Mask.
§ 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.