(192 days)
The ELux810 Laser is indicated for hair removal, permanent hair reduction in people with Fitzpatrick skin type I-V. It is also indicated for the treatment of benign superficial vascular and benign superficial pigmented lesions in people with Fitzpatrick skin type I-IV. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen.
The ELux810 Laser is a diode laser of 808nm system. This device is composed of a main body to operate each function of equipment and a hand piece for irradiation of laser, and is designed to use in various treatments by effecting to skin by laser beam of 808nm generated from laser diode. Diode laser of CW system is able to transfer stable and uniform pulses to skin, therefore medical doctor can treat patient safely and effectively using this equipment.
This document (K141986) is a 510(k) premarket notification for the ELux810 Medical Laser. It primarily focuses on demonstrating substantial equivalence to a predicate device (Emvera Diolux Laser) rather than providing detailed clinical study results with acceptance criteria in the typical sense of an AI/ML device performance study.
Therefore, the specific information requested in your prompt (e.g., sample sizes for test sets, number of experts, adjudication methods for ground truth, MRMC studies, standalone performance, training set details) is not present in this document. This document describes a medical device (a laser) and its technical specifications, and the regulatory approval process relies on demonstrating that this new device is fundamentally similar and performs comparably to an already legally marketed device with established safety and effectiveness.
Here's a breakdown of what can be extracted regarding "acceptance criteria" and "device performance" in the context of this 510(k), along with an explanation of why other requested details are not applicable:
1. A table of acceptance criteria and the reported device performance
In the context of this 510(k), "acceptance criteria" are essentially met by demonstrating that the ELux810 Laser's characteristics and performance are "substantially equivalent" to the predicate device, Emvera Diolux Laser. The performance is assessed by comparing technical specifications and ensuring adherence to recognized standards for laser devices.
| Acceptance Criteria (Demonstration of Substantial Equivalence to Predicate) | ELux810 Medical Laser Reported Performance (Specifications) |
|---|---|
| Indications for Use: Same as predicate | Hair removal, permanent hair reduction (Fitzpatrick skin type I-V); treatment of benign superficial vascular and benign superficial pigmented lesions (Fitzpatrick skin type I-IV). |
| Principal of Operation: Same as predicate | Laser beams highly concentrated light into hair follicles; pigment absorbs light, destroying hair. |
| Light Source: Same as predicate | Diode (Continuous Wave) |
| Wave Length: Same as predicate | 808 nm |
| Laser Diode Power: Max 600w (Same as predicate) | Max 600w |
| Energy Density/Fluence: Up to 120J/cm2 (Same as predicate) | Up to 120J/cm2 |
| Mode: Pulsed (Same as predicate) | Pulsed |
| Pulse Duration: 5-625ms (SE to predicate) | 5-625ms |
| Pulse Repetition Rate (Repetition): 1-2 Hz DP 2, 1-6 Hz DP 1, 5-10 Hz FDP Mode (SE to predicate) | 1-2 Hz DP 2, 1-6 Hz DP 1, 5-10 Hz FDP Mode |
| Spot Size: 12 x 11 mm (SE to predicate) | 12 x 11 mm |
| Cooling: Water Cooling (-5°C~5°C) (SE to predicate) | Water Cooling (-5°C~5°C) |
| Optical Guide: Sapphire Crystal (Same as predicate) | Sapphire Crystal |
| Power Input: 120/230V 20/10 A 50/60 Hz (Same as predicate) | 120/230V 20/10 A 50/60 Hz |
| Met US FDA Guidance Documents | Guidance on the Content and Organization of a Premarket Notification for a Medical Laser (Draft), June 1995 |
| Met US Regulations | 21CFR Part 1040, Sections 1040.10 and 1040.11 with permissible deviations relative to Laser Notice 50, dated June 24, 2007. |
| Met Recognized Consensus Standards | ISO 14971, IEC 60601-1, EN 60601-1-2, EN 60601-1-6, IEC 60601-2-22, IEC 60825-1, IEC 62304, IEC 62366-1 |
Explanation for "SE" (Substantially Equivalent) in the table: In the context of a 510(k), "SE" means the characteristic is sufficiently similar to the predicate that it does not raise new questions of safety or effectiveness. The slight differences in spot size and pulse repetition rates are considered minor and don't alter the fundamental safety or efficacy profile compared to the predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this 510(k) submission. This document states "None submitted" for clinical tests (H. Discussion of Clinical Tests). The approval is based on demonstrating substantial equivalence through technical comparison and adherence to safety standards, not a new clinical study with a test set of patient data from an AI/ML context.
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. As no clinical test set was submitted, there was no need for experts to establish ground truth in this manner.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication was submitted.
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 a laser surgical instrument, not an AI/ML diagnostic or assistive device for human readers. No MRMC study was conducted or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical laser, not a software algorithm. Its performance is inherent to its physical operation and specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not directly applicable in the AI/ML sense. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device (Emvera Diolux Laser) and the general scientific understanding of how 808nm diode lasers function for the stated indications. The ELux810 is assumed to have similar safety and effectiveness because its technical characteristics are substantially equivalent. The definition of "Permanent hair reduction" (long-term, stable reduction at 6, 9, 12 months) serves as an outcome measure, but it's a definition for the indication, not a ground truth used in a study reported here to validate new AI performance.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML algorithm was used.
In summary, this 510(k) submission for the ELux810 Medical Laser establishes its acceptance and suitability for market based on:
- Substantial equivalence of its technical specifications and intended use to a legally marketed predicate device.
- Compliance with recognized safety and performance standards for medical lasers (e.g., ISO, IEC, EN standards).
- Adherence to relevant FDA regulations and guidance documents.
The provided document explicitly states "None submitted" for clinical tests, which is why the detailed information about clinical study design, ground truth, and reader performance you requested for AI/ML devices is not found here.
§ 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.