(215 days)
DermRays Revive is intended for hair reduction. Permanent hair reduction is defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
DermRays Revive is also intended for treatment of wrinkles.
DermRays Revive is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
DermRays Revive uses a diode laser with an output wavelength of 1064nm, to act on the dermis through the epidermis, and the laser energy is absorbed by the target tissues (melanin, hemoglobin, and water).
Due to the selective photothermal effect of the laser, it can treat wrinkles, without damaging the skin. Simutaneously, the laser can act on the melanin in the hair follicles, destroy hair follicles in the growth around the hair follicles, so as to remove hairs.
The device consists of a power adapter, a power cord and a main unit.
The provided text is a 510(k) summary for the DermRays Revive device, which is a laser surgical instrument. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria through a clinical trial or extensive performance testing with clearly defined metrics.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert ground truth establishment, and MRMC studies are not present in this document because they are generally not required for a 510(k) submission that relies on demonstrating substantial equivalence to existing predicate devices, especially when no clinical testing was performed.
However, based on the information provided, here's what can be extracted and what is explicitly stated as not performed:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of quantitative "acceptance criteria" for the device's clinical performance (e.g., a specific percentage of hair reduction or wrinkle improvement expected). Instead, it demonstrates substantial equivalence to predicate devices based on shared technical characteristics and intended use. The "performance" assessment is primarily through non-clinical testing to ensure safety and functionality.
The table presented (Table 1) is a comparison of the proposed device's technical specifications and intended uses against its predicate devices, not acceptance criteria for clinical efficacy.
Table 1: Comparison of Proposed Device (DermRays Revive) with Predicate Devices (Summary)
| Characteristic | Proposed Device (DermRays Revive) | Primary Predicate (Cynosure Elite+ Laser) | Secondary Predicate (Diode Laser Hair Removal) | Comparison |
|---|---|---|---|---|
| Acceptance Criteria/Performance Metrics (as per document) | Not explicitly defined as quantitative clinical metrics. The acceptance is based on demonstrating substantial equivalence regarding: | |||
| Indications for Use | Hair reduction, permanent hair reduction (at 6, 9, 12 months), wrinkle treatment; all skin types (I-VI), including tanned skin. | Hair reduction, permanent hair reduction (at 6, 9, 12 months), wrinkle treatment, various skin/vascular/pigmented lesions. | Hair reduction, permanent hair reduction (at 6, 9, 12 months); all skin types (I-VI), including tanned skin. | Same/Similar |
| Laser Type | Solid state | Solid state | Solid state | Same |
| Wavelength | 1064nm±10nm | 1064nm±10nm | 1064nm±10nm | Same |
| Pulse Width | 400ms | 0.1ms-300ms | LHR-V6S-1064: 350ms-450ms; LHR-V6S/B-1064: 280ms-400ms | Same (to one secondary predicate model) |
| Single Pulse Max. Energy Density | 5.0J/cm² - 10.0J/cm² | 4.7J/cm² (24mm spot) - 12.0J/cm² (15mm spot) | LHR-V6S-1064: 5J/cm², 6J/cm², 7J/cm²; LHR-V6S/B-1064: 4J/cm², 5J/cm², 6J/cm² | Similar (Differences do not affect safety/effectiveness) |
| Handpiece Spot Size | 15mm | 3mm, 5mm, 7mm, 10mm, 12mm, 15mm, 18mm, 20mm, 22mm & 24mm | 30mm×10mm | Same (to 15mm option of primary predicate) |
| Working Area | 1.766cm² | 4.522cm² (24mm spot) - 1.766cm² (15mm spot) | 3cm² | Same (to 15mm option of primary predicate) |
| Input Voltage | AC100-240V, 50/60Hz, 1.6A Max. | 208/240VAC, 30A, 50/60Hz, Single Phase | AC100-240V, 50/60Hz, 1.6A Max. | Same |
Study Proving Device Meets Acceptance Criteria:
The study proving the device's substantial equivalence and suitability for market is detailed through non-clinical testing as follows:
- Biocompatibility Testing: Performed on parts contacting skin (ISO 10993-1, -5, -10, -23)
- Electrical Safety and Electromagnetic Compatibility (EMC) Testing: Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-22 and IEC 60825-1.
- Software Verification and Validation: Performed according to FDA guidance.
- Performance Testing - Bench: Appearance, Function, Safety, Label.
- Shelf Life Test: Accelerated aging test and subsequent performance test.
- Cleaning and Disinfection Verification: Simulated cleaning and disinfection test and subsequent performance test.
The document explicitly states: "No clinical testing has been performed." This is a critical point for the remaining questions.
2. Sample sizes used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of a clinical test set, as no clinical testing was performed. The non-clinical tests involved samples of the device and its components.
- Data Provenance: The general context of the submission implies that all testing (biocompatibility, electrical safety, software, bench performance) was conducted by or for Wuhan Lotuxs Technology Co., Ltd. (China). The document does not specify whether these tests were done retrospectively or prospectively, but typically, pre-market non-clinical testing for a 510(k) is performed prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: Since no clinical studies were performed, there was no "ground truth" to establish for a test set by human experts (like radiologists for imaging devices). The ground truth for the non-clinical tests is based on adherence to established engineering, safety, and performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No clinical test set requiring expert adjudication was utilized.
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 explicitly states "No clinical testing has been performed." Therefore, no MRMC study was conducted, and no human-AI interaction or improvement was assessed. The device described is a laser instrument, not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device is a physical laser instrument. While it has software, its "performance" is primarily mechanical and energy delivery, not an algorithm providing a diagnostic or analytical output that would have a standalone performance metric in the way AI algorithms do. The software verification and validation ensured the software performs as intended for device operation, not as a standalone analytical tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable for Clinical Performance: As no clinical studies were performed, there was no clinical "ground truth" established from expert consensus, pathology, or outcomes data for efficacy.
- For Non-Clinical Tests: The "ground truth" for the non-clinical tests is defined by the requirements of the standards themselves (e.g., maximum allowable cytotoxicity, specific electrical safety thresholds, software functionality specifications).
8. The sample size for the training set
- Not Applicable: There is no mention of a "training set" for an algorithm in the context of this laser device submission.
9. How the ground truth for the training set was established
- Not Applicable: As no training set was mentioned.
§ 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.