(259 days)
The reVive Light Therapy® Essentials is an Over the Counter (OTC) device intended for treatment of writkles.
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 wrinkles. The device uses four types of LEDs: 605nm amber, 630nm red, 660nm red, and 880nm infrared. 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 FDA 510(k) summary for the reVive Light Therapy® Essentials does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of clinical efficacy (e.g., wrinkle reduction).
Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics, safety testing, and usability, which are common for 510(k) submissions for Class II devices.
Here's what can be extracted and what is missing, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not report specific acceptance criteria for clinical effectiveness (e.g., wrinkle reduction) nor does it provide performance metrics related to such an outcome study. The performance testing mentioned is primarily related to safety, functionality, and software.
| Acceptance Criteria (Clinical Efficacy - e.g., Wrinkle Reduction) | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
| Functional Performance Testing | Device conforms to various international consensus standards (ANSI/AAMI ES 60601-1:2005® + 2012, ANSI/AAMI/IEC 60601-1-2 (2014)). |
| Software Validation | Software was tested and validated in accordance with FDA guidance. |
| User Safety Testing | Device conforms to various international consensus standards (ANSI/AAMI ES 60601-1:2005® + 2012, ANSI/AAMI/IEC 60601-1-2 (2014)); Biocompatibility testing (ISO 10993-5, ISO 10993-10) passed. |
| Usability Study: Correct preparation of device | 100% of participants demonstrated correct preparation. |
| Usability Study: Correct device usage | 100% of participants demonstrated correct usage. |
Missing Information (for clinical efficacy study):
- Specific clinical acceptance criteria (e.g., a certain percentage reduction in wrinkle count, or a statistically significant improvement on a wrinkle severity scale).
- Quantitative results demonstrating the device's performance against clinical acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- For Usability Study:
- Sample size: 17 participants.
- Data provenance: Not specified, but generally, usability studies are prospective and often conducted in research facilities. The country of origin is not mentioned.
- For Clinical Efficacy Study:
- Sample size: Not applicable/not provided, as no clinical efficacy study is detailed.
- Data provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- For Usability Study: The "ground truth" here is objective observation of user actions. No external experts are mentioned for establishing ground truth; the performance was assessed by the study administrators.
- For Clinical Efficacy Study: Not applicable/not provided.
4. Adjudication Method:
- For Usability Study: Not explicitly stated as "adjudication," but the results indicate clear observation (100% correct demonstration). This implies direct observation and assessment by the study team.
- For Clinical Efficacy Study: Not applicable/not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No such study was mentioned in the provided document. The device is a direct-to-consumer light therapy device, not a diagnostic imaging AI algorithm typically subjected to MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical light therapy device, not an AI algorithm. "Standalone performance" in this context typically refers to the device's physical output and safety, which were tested and found to conform to standards.
7. The Type of Ground Truth Used:
- For Usability Study: Observed user behavior against predefined correct procedures.
- For Clinical Efficacy Study: Not applicable/not provided.
8. The Sample Size for the Training Set:
- Not applicable/not provided. The document describes a physical medical device (LED light therapy) and does not mention any machine learning or AI components requiring a "training set" in the context of typical AI algorithm development.
9. How the Ground Truth for the Training Set was Established:
- Not applicable/not provided. See point 8.
In summary: The provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence and safety/functionality for a light therapy device. It does not include a detailed clinical efficacy study with specific acceptance criteria, clinical performance metrics, or ground truth establishment relevant to an AI/diagnostic imaging context. The "study" mentioned is a usability study with 17 participants, assessing correct device operation, not clinical outcome.
§ 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.