(245 days)
Laser EpilME with EpilME applicator is indicated for use in surgical and aesthetic applications in the medical specialties of general and plastic surgery, and dermatology.
The EpilME is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
The EpilMe with EpilME Applicator is intended for:
- · Treatment of benign vascular lesions, including angiomas, telangiectasia and other benign vascular lesions and leg veins
- · Treatment of pseudofolliculitis barbae (PFB)
- · Hair removal, permanent hair reduction *
- · Treatment of benign pigmented lesions
*Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The Laser EpilME with EpilME applicator is an electro-optical device consisting of a laser console and applicator. The laser console provides a graphical user interface and software for control of the system, the needed electronics to control and power the accessories, handpiece connection port and cooling system.
Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the EpilME device:
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not present a detailed study proving the device meets specific acceptance criteria through clinical trials in the way you might expect for a new performance claim. Instead, it relies on comparison to a legally marketed predicate and adherence to recognized standards.
Here's an attempt to answer your questions based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for clinical performance in a quantifiable manner as you might see in a clinical study. Instead, it demonstrates substantial equivalence to a predicate device based on comparable intended use, indications for use, and technical specifications. The "performance" is implied by meeting recognized standards and having similar technical characteristics to the predicate.
| Acceptance Criteria (Implied by equivalence to predicate & standards) | Reported Device Performance (EpilME) |
|---|---|
| Safety and Effectiveness for Indications for Use: | EpilME has the same Indications for Use as the LightSheer Desire (K170179) predicate device (see below). |
| - Treatment of benign vascular lesions | Indicated |
| - Treatment of pseudofolliculitis barbae (PFB) | Indicated |
| - Hair removal, permanent hair reduction* | Indicated |
| - Treatment of benign pigmented lesions | Indicated |
| - Suitable for all skin types (Fitzpatrick I-VI), including tanned skin | Intended for use on all skin types (Fitzpatrick I-VI), including tanned skin. |
| - General Requirements for basic safety and essential performance (IEC 60601-1) | Test performed for IEC 60601-1:2005, AMD1:2012 |
| - Electromagnetic compatibility (IEC 60601-1-2) | Test performed for IEC 60601-1-2:2014 |
| - Particular requirements for safety and performance of laser equipment (IEC 60601-2-22) | Test performed for IEC 60601-2-22:2007 |
| - Biological Evaluation of Medical Devices (ISO 10993-1) | Test performed for ISO 10993-1:2018 |
| Technical Specifications comparable to predicate for effective treatment: | |
| - Output wavelength | 808 nm +/- 20nm |
| - Pulse Duration | 50 ms |
| - Spot Size | 10mm x 21 mm |
| - Max Energy | Up to 80J |
| - Rep Rate | Up to 12 Hz |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" with a specific sample size and data provenance (e.g., country of origin, retrospective/prospective). The submission relies on demonstrating technical equivalence to a predicate device and adherence to recognized performance standards (e.g., IEC, ISO). This indicates that the primary "testing" for this 510(k) involves engineering bench testing and a comparison of specifications, not a clinical study on a patient cohort for the EpilME itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As described above, there is no clinical "test set" or ground truth established by experts in this 510(k) summary for the EpilME device's performance. The ground truth for the predicate device's efficacy would have been established during its original clearance/approval process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no described clinical "test set" with 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 EpilME is a laser device, not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC study related to human reader improvement with AI is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The EpilME is a physical laser device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the EpilME device itself, the "ground truth" for its safety and functional performance is based on engineering standards (IEC, ISO) and the demonstrated technical equivalence to the predicate device, which has established clinical efficacy for its stated indications. There is no new clinical ground truth generated for the EpilME beyond these comparisons and standards adherence.
8. The sample size for the training set
Not applicable. This device is a laser system, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
In summary:
This 510(k) submission for the EpilME laser system primarily demonstrates substantial equivalence to a previously cleared predicate device (LightSheer Desire Laser System K170179) and compliance with recognized safety and performance standards. It does not present a de novo clinical study with specific acceptance criteria, a test set, expert adjudication, or MRMC/AI performance data for the EpilME itself. The "proof" the device meets acceptance criteria is derived from its similar technical specifications and intended uses to a device already deemed safe and effective by the FDA, and its adherence to relevant electrical and biological safety standards.
§ 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.