(148 days)
The LightStim Elipsa is a LED light therapy device which uses specific wavelengths of light emitting diodes (LEDs). It is intended to emit energy in the red and infrared region of the light spectrum to provide treatment for full face wrinkles. The blue and red light spectrum is intentent of mild to moderate inflammatory acne.
The LightStim Elipsa is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of acne and wrinkles. The device uses four types of LEDs for Wrinkles: 612nm amber, 645nm red, 655nm red, and 850nm infrared and two types of LEDs for Acne: 410nm and 645nm. The treatment time is controlled by the user. There are no user settings or adjustments required. The LightStim Elipsa system components include the device containing the LED module, power supply, goggles, and travel case. The LightStim Elipsa does not contain any user serviceable components. The device is sold as Over-the-counter (OTC)
The provided text describes a 510(k) premarket notification for the LightStim Elipsa device, an over-the-counter LED light therapy device for treating full-face wrinkles and mild to moderate inflammatory acne.
Based on the provided information, the document does not contain acceptance criteria or a study that directly proves the device meets specific performance criteria related to clinical efficacy (e.g., reduction in wrinkles or acne). Instead, the performance testing focuses on safety, electrical compatibility, software validation, and usability for regulatory clearance.
Here's a breakdown of the available information and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, there are no reported clinical performance acceptance criteria (e.g., percentage reduction in wrinkles, or acne lesion count reduction) or corresponding clinical efficacy results in this document. The "Performance Testing" section describes compliance with various safety and electrical standards.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Electrical Safety | Conformance to AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012 4th Edition: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance. | Device was tested for conformance and passed. |
| Electromagnetic Compatibility | Conformance to IEC 60601-1-2:2014 4th Edition Medical Electrical Equipment – Part 1-2: General Requirements for Safety and Essential Performance- Collateral standard: Electromagnetic Compatibility-Requirements and tests. | Device was tested for conformance and passed. |
| Usability/Human Factors | Conformance to IEC 60601-1-6:2010, IEC 60601-1-11:2015, IEC 60601-2-83:2019 including gap analysis demonstrating conformance to IEC 60601-2-57:2011. | Device was tested for conformance and passed. |
| Label Comprehension | Evaluation and measurement of labeling comprehension, device usability, self-selection component, and training effectiveness by "intended users" of the Elipsa device. | "The results of this testing on the final version of the labeling and instruction plan showed that the instructions were effective and intended users were able to understand the labeling and apply this information to device use for the primary operating functions of the device." |
| Software Verification/Validation | Documentation as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software in Medical Devices," for a minor (A) level of concern (malfunction of software could not lead to patient injury). | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software in Medical Devices. The minor (A) level of concern was determined because malfunction of, or a latent design flaw in the software could not lead to a patient injurv [sic]." |
2. Sample size used for the test set and the data provenance
- For Usability/Label Comprehension Study: The document states "The sponsor conducted a Usability/Label Comprehension study to acquire data..." but does not specify the sample size of participants or the data provenance (e.g., country of origin, retrospective/prospective).
- For Clinical Efficacy: No clinical test set or efficacy data is presented in this document. The 510(k) submission relied on substantial equivalence to predicate devices, which means they are claiming the new device is as safe and effective as already legally marketed devices, rather than conducting new clinical trials for efficacy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- For Usability/Label Comprehension Study: This type of study typically involves user feedback, not expert ground truth establishment for medical diagnosis. The document does not mention experts establishing ground truth for this study.
- For Clinical Efficacy: Not applicable, as no clinical efficacy test set or ground truth is described in this document.
4. Adjudication method for the test set
- Not applicable, as no clinical efficacy test set or adjudication process is described.
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, not an AI-powered diagnostic or interpretive device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical LED light therapy device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Usability/Label Comprehension Study: The "ground truth" here would be the actual comprehension and successful use of the device by the study participants based on the instructions. This is assessed directly through observation and user feedback, not by expert consensus or pathology.
- For Clinical Efficacy: Not applicable, as no clinical efficacy ground truth is described in this document.
8. The sample size for the training set
- Not applicable. This document pertains to regulatory clearance for a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. (See #8)
In summary, the provided document focuses on regulatory compliance through substantial equivalence to predicate devices and performance testing related to electrical safety, electromagnetic compatibility, software validation, and usability. It does not contain information about clinical efficacy studies, clinical acceptance criteria, or clinical performance data for wrinkle reduction or acne treatment beyond the general indications for use established by the predicates.
§ 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.