(265 days)
The reVive Light Therapy® Essentials is an Over the Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
The reVive Light Therapy® Essentials is an over-the counter light emitting diode (LED) device, that emits energy for use in dermatology for the treatment of mild to moderate inflammatory acne. The device uses two types of LEDs: 630nm red and 415nm blue. The reVive Light Therapy® Essentials components include the device containing the LED module. There are no user settings or adjustments required. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.
The provided text describes the regulatory clearance of the "reVive Light Therapy® Essentials" device. While it details performance testing conducted for safety and functionality, it does not include information about clinical studies proving the device's efficacy in treating mild to moderate inflammatory acne against specific acceptance criteria.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, intended use, and safety testing (electrical, EMC, biocompatibility, software validation, and usability). It explicitly states: "The conclusions drawn from nonclinical tests demonstrate that the device is safe, as effective, and performs as well as the legally marketed devices." This implies that clinical efficacy, such as a reduction in acne severity, was not a primary part of this submission for demonstrating substantial equivalence, but rather inferred from the predicate devices.
Therefore, for the aspects of your request related to clinical efficacy and performance against specific acceptance criteria for treatment outcomes (e.g., reduction in inflammatory lesions), the provided text does not contain the necessary information. I will fill in what is available and state when information is not present.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance Study (as described in the document):
The document does not detail acceptance criteria related to a specific clinical efficacy outcome (e.g., percentage reduction in acne lesions) nor does it present results from a clinical study proving such efficacy for the new device. Instead, the "Performance Testing and Standards" section focuses on safety and functionality.
1. A table of acceptance criteria and the reported device performance
Since no clinical efficacy acceptance criteria are presented, this table will focus on the non-clinical performance and safety criteria mentioned.
| Acceptance Criterion (Type: Functional/Safety) | Reported Device Performance |
|---|---|
| Electrical Safety (compliance with ANSI/AAMI ES 60601-1:2005 + A1:2012, IEC 60601-1:2005) | Device conforms to standard. Requires further information for specifics. |
| Electromagnetic Compatibility (EMC) (compliance with ANSI/AAMI/IEC 60601-1-2 (2014)) | Device conforms to standard. Requires further information for specifics. |
| Biocompatibility - Cytotoxicity (compliance with ISO 10993-5:2009) | Device conforms to standard. Requires further information for specifics. |
| Biocompatibility - Intracutaneous Reactivity (compliance with ISO 10993-10:2010) | Device conforms to standard. Requires further information for specifics. |
| Biocompatibility - Skin Sensitization (compliance with ISO 10993-10:2010) | Device conforms to standard. Requires further information for specifics. |
| Biocompatibility - Acute Systemic Toxicity (compliance with ISO 10993-11:2017) | Device conforms to standard. Requires further information for specifics. |
| Biocompatibility - Material Medicated Pyrogenicity (compliance with USP General Chapter 151) | Device conforms to standard. Requires further information for specifics. |
| Software Validation (compliance with FDA Guidance for Content of Premarket Submissions for Software) | Software was tested and validated. Requires further information for specifics. |
| Usability - Correct preparation of device for use | 100% of participants were able to demonstrate correct preparation. |
| Usability - Correct device usage | 100% of participants were able to demonstrate correct device usage. |
2. Sample size used for the test set and the data provenance
- Sample Size for Usability Study: 16 participants.
- Data Provenance: Not specified in terms of country of origin or whether it was retrospective/prospective for the usability study. The document is an FDA submission for a US market, suggesting US relevance, but this is not explicitly stated for the data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Applicability: This question is typically relevant for studies involving expert interpretation of data (e.g., medical images).
- In this context: For the usability study, there wouldn't be "ground truth" established by experts in the same way. The performance was measured by participant actions. For the functional/safety testing, compliance was assessed against recognized standards, implying expert evaluation by the testing body, but specific numbers and qualifications are not provided here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Applicability: This is typically for studies where multiple annotators establish ground truth for complex data.
- In this context: Not applicable to the usability study or the stated safety/functional testing.
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
- Applicability: This is for AI-assisted diagnostic devices.
- In this context: Not applicable. The "reVive Light Therapy® Essentials" is a light therapy device for acne, not an AI diagnostic tool. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Applicability: This is for AI/algorithm performance directly.
- In this context: Not applicable. This device is a direct treatment device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For Usability Study: The "ground truth" was predefined correct procedures for device preparation and usage, against which participants' actions were evaluated.
- For Safety/Functional Testing: Compliance with specified international and national standards (e.g., IEC 60601 series, ISO 10993 series, USP chapters). The ground truth is the performance specification defined by these standards.
8. The sample size for the training set
- Applicability: This is for AI/machine learning models.
- In this context: Not applicable. No AI/ML model for which "training data" would be used is described for this device.
9. How the ground truth for the training set was established
- Applicability: This is for AI/machine learning models.
- In this context: Not applicable. No AI/ML model for which "training data" would be used is described for this device.
Summary of what the document focuses on for "proving the device meets acceptance criteria":
The core of the submission, as per the text, relies on substantial equivalence to legally marketed predicate devices, combined with comprehensive non-clinical safety and functional testing. The rationale is that since the new device has "similar technical characteristics," "same control mechanism, same operating principle, and energy type," and the "same method of operation" as already cleared predicate devices for the same intended use (mild to moderate inflammatory acne), and it passes all safety and functional tests, it is deemed safe and effective. The minor changes in size were also assessed and found not to introduce new risks.
§ 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.