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The reVive Light Therapy LED Cleansing System is intended for treatment of wrinkles and mild to moderate inflammatory acne.

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 and mild to moderate inflammatory acne, as defined in 21 CFR § 878.4810. 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 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).

This document describes a 510(k) premarket notification for the reVive Light Therapy® LED Cleansing System (K221430). It establishes substantial equivalence by comparing the new device to two predicate devices (K180445 and K180447).

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria for clinical performance (e.g., specific reduction percentages for wrinkles or acne severity scores). Instead, it relies on demonstrating that the modified device performs "as well as the legally marketed devices" and meets "product system requirements, which is based on the predicate devices."

The table below summarizes the comparison of technological characteristics between the new device and its predicates, which forms the basis of the performance claim.

Study Proving Acceptance Criteria:

The document describes a study that aimed to confirm that the modifications made to the device were "correctly implemented and that the device performs as well as the legally marketed devices." The study focused on software testing and validation:

• Study Name/Description: The specific name of the study is not given, but it is described as "Testing" in Section 6.
• Methodology: The "reVive Light Therapy® LED Cleansing system software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices."
• Conclusion: The testing "confirmed that modifications made to the device were correctly implemented and that the device performs as well as the legally marketed devices."

Important Note: This submission is a 510(k) for a modified device, leveraging existing predicates. Clinical studies demonstrating efficacy for wrinkles and acne are implied to have been conducted for the original predicate devices, not extensively for this specific modification, which primarily involves updated software and associated hardware while maintaining the fundamental scientific technology and parameters.

Here's the breakdown for the additional information requested, based on the provided text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The document states "The reVive Light Therapy® LED Cleansing system software was tested and validated..." but does not provide details on the number of test cases, subjects, or data points used during this software testing and validation.
• Data Provenance: Not specified. There is no mention of the origin (e.g., country) of any data used for testing, nor whether it was retrospective or prospective. Given it's a software validation for a hardware modification, it's likely internal testing without external patient data.

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/Not specified. The document describes software testing and validation for a device modification, not a clinical study requiring expert ground truth for diagnostic or therapeutic outcomes on patients. The "ground truth" here would likely be defined by engineering and software requirements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of images or symptoms by multiple experts. This documentation focuses on software and hardware verification against established design specifications and predicate performance.

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

• No. A multi-reader, multi-case comparative effectiveness study (MRMC) was not conducted or reported in this document. This device is an LED therapy system for direct use, not an AI-assisted diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This is not an AI algorithm in the context of diagnostic or interpretive tools; it's an LED therapy device with software controls. The "standalone" performance here refers to the device's functional integrity as a light therapy system. The document states that "Testing confirmed that modifications made to the device were correctly implemented and that the device performs as well as the legally marketed devices." This implies testing of the device's operational parameters (light output, timing, power, etc.) in a standalone capacity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the software testing and validation mentioned, the "ground truth" would be the design specifications and functional requirements of the device's software and hardware, as well as the established performance of the predicate devices. It is not clinical ground truth like pathology or patient outcomes for this specific submission, but rather adherence to engineering and safety standards.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI algorithm in the context of a "training set." The device is a physical light therapy product.

9. How the ground truth for the training set was established

• Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this submission.

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reVive Light Therapy® LED Cleansing System is an Over-the-Counter (OTC) LED device intended for use in treating mild to moderate inflammatory acne.

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 mild to moderate inflammatory acne. The device uses two types of LEDs: 630nm red and 415nm blue. The treatment time is controlled by the user. There are no user settings or adjustments required. The reVive Light Therapy® LED Cleansing System components include the unit containing the LED module, USB power cord, and power adapter. 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). It is intended for users 13 years or older.

The provided FDA 510(k) summary for the reVive Light Therapy® LED Cleansing System (K180447) does not contain a typical acceptance criteria table with reported device performance metrics in the way a clinical study for diagnostic or prognostic devices would.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Clear Bi-Light K153081) through comparison of technological characteristics and performance testing related to safety and functionality. The "acceptance criteria" can be inferred from the comparisons made to the predicate device and the pass/fail nature of the safety and usability tests.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Since there isn't a direct table in the document, I will construct one based on the information provided, inferring acceptance criteria from the comparisons to the predicate and the documented test results.

2. Sample Size Used for the Test Set and Data Provenance

• Usability Study Test Set: 15 participants.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This was a usability study, often conducted in a controlled environment, likely in the US where the submitter is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to the studies presented for this device.

• For the usability study, "ground truth" was about successful execution of tasks and demonstrating light sensitivity, not clinical diagnosis. The performance was measured by participant action, not expert judgment.
• For the safety and functional performance testing, "ground truth" was established by adherence to international standards (e.g., IEC, ISO) and internal testing protocols, not by expert consensus on clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. The usability study involved observing participants' actions (e.g., "100% of the participants were able to demonstrate the light sensitivity test."). Safety and performance tests against standards have pass/fail criteria, not adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This type of study is for diagnostic devices where human readers interpret medical images or data. The reVive Light Therapy® LED Cleansing System is a direct treatment device, not a diagnostic tool requiring human interpretation with or without AI assistance.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done

Yes, in a sense. The "performance testing" described (functional performance testing, software validation, safety testing, thermal performance testing) essentially represents standalone performance of the device's physical and software aspects against defined specifications and standards, without real-time human intervention influencing its core operation during the test.

7. The Type of Ground Truth Used

• Usability Study: User performance metrics (ability to demonstrate a test, successful device use).
• Safety and Functional Testing: Adherence to established international consensus standards (IEC, ISO) and internal performance specifications (e.g., thermal limits, software functionality).
• Substantial Equivalence: Comparison to the technological characteristics, intended use, and treatment parameters of a legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. This device is an LED therapy system, not an AI/machine learning algorithm that requires a training set in the typical sense. The software validation is likely for operational logic and safety features, not for learning from data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

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