(262 days)
The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
The DemarkQ, Model: DemarkQ WOW(PB-B), DemarkQ POP(SJ-72) are over-the counter light emitting diode (LED) panel device, that emits energy for use in dermatology for the treatment of mild to moderate inflammatory acne. The devices use two types of LEDs: 630nm red and 415nm blue. The device operated only by one key, both wavelengths will be emitted at the same time when it be turned on. The treatment time is controlled by the user. There are no user settings or adjustments required.
The device's components include the main device which containing the LED treatment module, USB power cord and goggles.
The provided document is a 510(k) summary for the DemarkQ WOW and DemarkQ POP devices, which are LED-based light therapy devices for the treatment of mild to moderate inflammatory acne.
Based on the content, here's an analysis of the acceptance criteria and the "study" that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., efficacy rates, reduction in lesion counts) for the device itself in treating acne. Instead, it focuses on demonstrating Substantial Equivalence (SE) to predicate devices based on technological characteristics and adherence to safety and performance standards.
The "acceptance criteria" can be inferred from the comparison to predicate devices and the listed standards. The implicit acceptance criteria are that the device should:
- Have the same intended use and indications for use as predicate devices.
- Have similar technological characteristics (e.g., wavelengths, type of light source, power supply within safe limits).
- Comply with recognized medical device safety, EMC, usability, and biocompatibility standards.
Inferred Acceptance Criteria and Reported Device Performance (Summary derived from the comparison table):
| Feature/Criteria | Acceptance Criterion (Implicit) | Reported Device Performance (DemarkQ WOW / POP) | Met? |
|---|---|---|---|
| Intended Use | Treatment of mild to moderate inflammatory acne (same as predicates). | "The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne." | Yes |
| Wavelengths | Deliver red and blue light within dermatologist-recognized therapeutic ranges (similar to predicates). | Red: 630nm±10nm, Blue: 415nm±10nm (similar to predicates' 415nm/630nm, 633±10nm/417±10nm) | Yes |
| Irradiance | Deliver light at an irradiance level comparable to predicate devices and within safe therapeutic ranges. | DemarkQ WOW: Red: 5 mW/cm², Blue: 25 mW/cm²; DemarkQ POP: Red: 25 mW/cm², Blue: 25±5 mW/cm² (comparable to predicates, within safety standards). | Yes |
| Light Source | LED-based light source. | LEDs. | Yes |
| Treatment Time | Typical treatment duration (e.g., 3 minutes) per session. | 3 minutes per treatment. Can be used daily. | Yes |
| Power Supply | Safe and effective power delivery, compliant with electrical safety standards. | DemarkQ WOW: Battery (2 x 3.7Vdc, 2700 mAh lithium battery), Adapter Input: 100-240Vac, 50/60Hz, Output: DC 5V, 2A. Main unit input: DC 5V, 2A. | |
| DemarkQ POP: Battery (3.7Vdc, 1500 mAh lithium battery), Adapter Input: 100-240Vac, 50/60Hz, Output: DC 5V, 2A. Main unit input: DC 5V, 2A. Compliant with IEC 60601-1, -1-11, -1-2. | Yes | ||
| EMC | Compliance with electromagnetic compatibility standards. | IEC 60601-1-2. | Yes |
| Electrical Safety | Compliance with general and particular electrical medical equipment safety standards. | IEC 60601-1, IEC 60601-2-57, IEC 60601-1-11, IEC 62471. | Yes |
| Biocompatibility | Compliance with biological evaluation standards for medical devices (for patient contact materials). | ISO 10993-1, ISO 10993-5, ISO 10993-10. | Yes |
| Usability | Compliance with usability standards for medical electrical equipment. | IEC 60601-1-6. | Yes |
| Software | Compliance with medical device software lifecycle standards (if applicable). | IEC 62304. | Yes |
The "study" that proves the device meets the acceptance criteria is primarily a demonstration of Substantial Equivalence (SE) to legally marketed predicate devices through a comparison of technological characteristics and adherence to recognized consensus standards. The document explicitly states: "The DemarkQ, Model: DemarkQ WOW(PB-B), DemarkQ POP(SJ-72) have been evaluated the safety and performance by lab bench testing as following:" followed by a list of international standards.
2. Sample size used for the test set and the data provenance:
The document describes laboratory bench testing and comparison to predicates, not a clinical study on human subjects for efficacy. Therefore, there is no "test set" in the sense of a patient cohort or retrospective dataset for assessing clinical performance. The testing involved samples of the device itself to verify compliance with various safety and performance standards (e.g., electrical safety, EMC, biocompatibility).
- Country of Origin of the data: Based on the submitter's address (Shenzhen, Guangdong, China), the lab bench testing was likely performed in China or by labs accredited to conduct these tests for the Chinese manufacturer.
- Retrospective or Prospective: Not applicable as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. Ground truth, in the context of clinical efficacy, would involve expert assessment of acne lesions or outcomes. Since this 510(k) submission doesn't include a de novo clinical efficacy study, it does not refer to experts establishing ground truth for efficacy. The "experts" involved would be the engineers and testing personnel who evaluated the device against the referenced standards, and possibly the regulatory specialists who prepared the submission, but their qualifications are not detailed here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. There is no clinical test set requiring adjudication of findings (e.g., disease presence/absence, lesion counts).
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 LED light therapy device for acne treatment, not an AI-powered diagnostic or assistive tool for human readers/clinicians, and thus an MRMC study is not relevant or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. Pertains to AI/software performance studies, which is not relevant for this hardware light therapy device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context is the compliance with recognized international consensus standards (e.g., IEC, ISO). The device's characteristics (e.g., wavelength, irradiance) were measured against specified parameters outlined in these standards and the comparison to predicate devices, rather than clinical outcomes or expert consensus on clinical images/pathology.
8. The sample size for the training set:
Not applicable. There is no "training set" as this is not a machine learning or AI-based device requiring training.
9. How the ground truth for the training set was established:
Not applicable. As above, no training set for an AI/ML model.
§ 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.