(84 days)
The reVive Light Therapy® LED Cleansing System is an Over-the-Counter (OTC) LED device intended for use in treating wrinkles.
The reVive Light Therapy® LED Cleansing System is an over-the counter light emitting diode (LED) device, that emits energy for use in dermatology for the treatment of wrinkles. The device uses four types of LEDs: 605nm amber, 630nm red, and 880nm infrared. In addition to the LED light therapy treatment function, reVive Light Therapy® LED Cleansing System has a separate function for cleansing. The system includes two cleansing brush-heads, constructed of TPE material. The reVive Light Therapy® LED Cleansing System components include the device containing the LED module, USB power cord, and power adapter. The treatment time is controlled by the user. 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 device is sold as Over the Counter (OTC).
The provided text describes a 510(k) premarket notification for the "reVive Light Therapy LED Cleansing System," an Over-the-Counter (OTC) LED device intended for treating wrinkles and cleansing. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a specific clinical performance against acceptance criteria for a novel AI/software medical device.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" for a complex AI/software medical device, such as a table of performance metrics (sensitivity, specificity, AUROC), sample sizes for AI model training/testing, expert adjudication, MRMC studies, and detailed ground truth establishment, are not applicable to this specific 510(k) submission.
This submission is for an LED light therapy device, not an AI or software-driven diagnostic or therapeutic device that requires performance validation against specific clinical endpoints like identifying disease. The "performance testing" mentioned is primarily focused on safety, functional performance, software validation (for basic control software), and biocompatibility, not clinical efficacy measured by common AI metrics.
However, I can extract the relevant information regarding the device's validation and "acceptance criteria" as presented in this 510(k) summary, interpreting "acceptance criteria" in the context of device safety and functional performance for this type of device.
Acceptance Criteria and Device Performance for ReVive Light Therapy LED Cleansing System
Based on the provided 510(k) summary, the "acceptance criteria" for this device are primarily related to safety, functional performance, and substantial equivalence to legally marketed predicate devices, rather than the diagnostic or therapeutic accuracy metrics typically associated with AI/ML medical devices.
1. Table of "Acceptance Criteria" (interpreted as demonstrated compliance with standards and successful functional tests) and Performance:
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance / Compliance |
|---|---|---|
| Safety & Electrical Performance | IEC 60601-1:2012 (Medical Electrical Equipment - Basic Safety & Essential Performance) | Conforms to standard. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 (Medical Electrical Equipment - Collateral Standard: EMC) | Conforms to standard. |
| Software Validation | FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices" | Software was tested and validated in accordance with FDA guidance. |
| Biocompatibility (ABS Material) | ISO 10993-5:2009 (Cytotoxicity Test) | Test article extract did not show potential toxicity to test cell culture. |
| Biocompatibility (ABS Material) | ISO 10993-10:2010 (Intracutaneous Reactivity Test) | Applied sample extract did not induce intracutaneous reactivity. |
| Biocompatibility (ABS Material) | ISO 10993-10:2010 (Skin Sensitization Test) | Test article extract showed no significant evidence of causing skin sensitization. |
| Biocompatibility (TPE Material) | ISO 10993-5:2009 (Cytotoxicity Test) | Test article extract did not show potential toxicity to test cell culture. |
| Biocompatibility (TPE Material) | ISO 10993-10:2010 (Intracutaneous Reactivity Test) | Applied sample extract did not induce intracutaneous reactivity. |
| Biocompatibility (TPE Material) | ISO 10993-10:2010 (Skin Sensitization Test) | Test article extract showed no significant evidence of causing skin sensitization. |
| Usability / User Performance | Ability to demonstrate light sensitivity test | 100% of participants were able to demonstrate the light sensitivity test. |
| Usability / User Performance | Ability to use the device successfully | 100% of participants were able to use the device successfully. |
| Functional Performance | (General statement) | Functional performance testing conducted. Device performs as intended. |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Software Validation/Functional Performance/Safety Testing: No specific numerical sample size (e.g., number of test cases run) is provided, but it's stated that "Testing... included functional performance testing, software validation, testing, and user safety testing," confirming these tests were conducted.
- Biocompatibility Testing: The number of biological samples or subjects for the biocompatibility tests are not explicitly stated, but the summary refers to "test cell culture" and "test subject(s)."
- Usability Study: 15 participants.
- Data Provenance: Not specified, but generally, these types of tests are conducted in a controlled laboratory environment (e.g., in-house or by contract research organizations) and are not clinical data from patients in a specific country. This is a pre-market submission, not a clinical trial report.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- For Biocompatibility Tests: The "ground truth" (e.g., toxicity, reactivity, sensitization) is established by standard laboratory methods and read/interpreted by qualified personnel in the testing lab according to the specified ISO standards. The number and specific qualifications of these experts are not provided in this summary.
- For Usability Study: The "ground truth" for usability is based on direct observation of user performance. No "experts" in the sense of adjudicators are mentioned, as the criteria (e.g., "100% were able to demonstrate...") are objective.
- For Electrical/EMC Standards: Compliance is determined by testing against the specified standards, likely by qualified engineers. No mention of "experts" establishing a "ground truth" in the clinical sense.
4. Adjudication Method for the Test Set:
- Not applicable in the context of clinical AI performance. The tests described are compliance-based, functional, and usability assessments, not clinical data adjudication for diagnostic accuracy.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study (comparing human readers with and without AI assistance for interpretation) is not relevant to an LED light therapy device. The device's "effectiveness" is in treating wrinkles, which is stated as being "substantially equivalent" to predicate devices, implying similar efficacy without detailed comparative studies of human interpretive performance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve a diagnostic algorithm or AI that operates "standalone" in a clinical diagnostic sense. Its software controls the LED function and has no independent diagnostic or interpretive function.
7. The Type of Ground Truth Used:
- Functionality/Safety: Compliance with established engineering and safety standards (e.g., IEC standards, physical measurements of light output).
- Biocompatibility: Results of standardized in-vitro (cytotoxicity) and in-vivo (intracutaneous reactivity, skin sensitization) biological tests as per ISO 10993 standards.
- Usability: Direct observation of user interactions and task completion (e.g., demonstrating light sensitivity test, using the device successfully).
8. The Sample Size for the Training Set:
- Not applicable. This device does not utilize AI/ML, and therefore, there is no "training set" for an algorithm.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no AI/ML training set, this question does not apply.
§ 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.