(381 days)
The E-Light Line devices are intended for dermatological use by physicians and healthcare professionals as the following:
IPL Technology is intended for:
- Treatment of Acne (from 390 to 1200nm filter)
- Treatment of vascular and benign pigmented lesions, cutaneous lesions including warts, scars, striae , and facial and leg veins (from 550 to 1200nm filter).
- Removal of unwanted hair in all skin types (from 570- to 1200nm filter)
LED Technology is intended:
- Yellow LED 594 nm for treatment of periorbital wrinkles and rhytides
- Blue LED 428nm to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris
- Red LED 632nm for treatment of superficial, benign vascular and pigmented lesions
VACUUM Technology is intended to:
- Improve Lymphatic circulation in the treated area
The E-light Line is a family of devices with three types of output emitted from different handpieces. The outputs of the E-light Line are Intense Pulsed Light (IPL), LED and Vacuum. These outputs may be issued from different handpieces. The output handpieces are:
- IPL handpiece
- Led handpiece
- Led Body Band
- Led Masks
- Vacuum handpiece
Only one output source works at a time. All the E-Light line devices include a Main Unit that controls and manages the IPL, LED or Vacuum handpiece. The Main Unit contains all circuitry to control the device as the capacitor charge system, the microcontroller and all the electronic parts. The E-light line devices are: - Trinity Plus
- Evoluzione Plus
- EPI-C Plus
The E-Light Trinity Plus supports all the technologies (IPL, LED and Vacuum) and therefore all the handpieces. The E-Light Evoluzione Plus and EPI-C plus support the IPL and LED Technologies and therefore all the handpiece with the exception of the Vacuum handpieces.
The provided document is a 510(k) summary for the E-light Line of devices (IPL, LED and Vacuum equipment for dermatological use). It outlines the device's general information, predicate devices, device description, indications for use, and a statement of substantial equivalence.
Based on the provided text, here's an analysis of the acceptance criteria and study information:
No specific acceptance criteria or a dedicated study proving the device meets those criteria are explicitly reported in this 510(k) summary.
The document states: "No clinical study was been submitted." Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices. This means that the manufacturer is arguing that their device is as safe and effective as existing devices because it has the same intended use, similar technological characteristics, and similar applications, and no significant differences exist.
Therefore, the requested table of acceptance criteria and reported device performance cannot be generated directly from this document, as a formal performance study with predefined acceptance criteria is not presented. Similarly, most of the specific questions regarding sample sizes, ground truth establishment, expert qualifications, and adjudication methods are not applicable because clinical performance studies were not performed or submitted.
Here's what can be extracted and inferred regarding your request:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or formal performance data tied to specific metrics (e.g., sensitivity, specificity, accuracy for an AI device) are reported for the clinical effectiveness of the E-light Line. The submission focuses on substantial equivalence to predicate devices.
The only "performance data" mentioned are successful passes of electrical safety and electromagnetic compatibility tests:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with EN 60601-1:2004 (Electrical Safety) | Passed |
| Compliance with IEC 60601-1-2:2004 (Electromagnetic Compatibility) | Passed |
| Compliance with EN 980:2004 (Graphical Symbols) | Developed according to |
| Compliance with EN ISO 14971:2007 (Risk Management) | Developed according to |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set or data provenance is reported as "No clinical study was been submitted."
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. No clinical test set or ground truth establishment is reported.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication method is reported.
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. No MRMC study was done, as "No clinical study was been submitted." This device also does not appear to be an AI-driven device intended to assist human readers; it is a physical medical device (IPL, LED, Vacuum).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device. "No clinical study was been submitted."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No clinical ground truth was established as "No clinical study was been submitted."
8. The sample size for the training set
Not applicable. No training set is mentioned as "No clinical study was been submitted."
9. How the ground truth for the training set was established
Not applicable. No ground truth for a training set was established as "No clinical study was been submitted."
Summary Conclusion:
The provided 510(k) summary for the E-light Line demonstrates substantial equivalence by comparing its intended use, technological characteristics, and applications to several predicate devices. It relies on compliance with electrical safety and electromagnetic compatibility standards, along with recognized international standards for medical devices. It explicitly states that "No clinical study was been submitted," meaning there is no information in this document about specific acceptance criteria related to a clinical performance study, nor any data from such a study. Therefore, most of the detailed information requested regarding clinical performance evaluation, sample sizes, ground truth, and expert involvement is not present.
§ 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.