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The Rejuvalite MD, is a tabletop device that contains 120 LEDs split evenly into 4 different wavelengths. The total power density for combined wavelengths is approximately 62 mW/cm2 at a distance of 4" from the illuminating surface of the device. The labeling requires Users to maintain the distance between the illuminating surface and the treatment site at 4"during the treatment. There is a 4" distance limiting arm attached to the device to help users on determining and maintaining the 4" distance between the device's illuminating surface and the treatment site. The Rejuvalite MD system components include the tabletop unit consisting of the base, arm, and swivel head containing the LED module , 4" distance limiting arm, timer, internal UL approved power adapter, and goggles. The device incorporates a power adapter mounted inside of the lamp base that converts the AC to DC voltage. The power switch is operated to turn the device on or off. The unit is designed to be placed on a table for easy exposure to the face 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).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Rejuvalite MD device. Please note that the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo clinical study with strict acceptance criteria for a novel device. Therefore, some of the requested information, particularly regarding detailed clinical acceptance metrics and their achievement, may not be explicitly stated in the context of this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, particularly regarding safety, effectiveness, and key technical specifications. There are no explicit quantitative clinical performance acceptance criteria listed.

Acceptance Criterion (Implied by Substantial Equivalence)	Reported Device Performance (Rejuvalite MD)
Indications for Use	Intended for the treatment of full face wrinkles (matches predicate).
Treatment Regime	3 minutes daily, 5 days per week for 8 weeks (identical to predicate).
Power Density per Wavelength	Power density per wavelength (mW/cm²) at 4" distance is identical to the predicate device.
Total Power Density of Combined Wavelengths	62 mW/cm² at a distance of 4" from the LED head (identical to predicate's 62 mW/cm² in contact).
Wavelengths	600, 622, 660, 860nm (similar to predicate's 605, 630, 660, 855nm).
Energy Source (LEDs)	120 LEDs, over 90cm² (predicate: 72 LEDs, over 40cm²). While the number of LEDs and surface area differ, the submission claims the "amount of energy (irradiance per area) delivered to the skin measured at 4" are identical to the predicate device."
Safety - Electrical & Optical	Conforms to IEC 60601-1 (general requirements for basic safety and essential performance) and IEC 60601-1-2 (EMC). Performance testing on optical and electrical characteristics demonstrated it is "almost identical" to the predicate.
Safety - Biocompatibility	Device body made of ABS plastic (same as predicate), considered safe for skin contact. Conclusion: "does not raise any new safety issues."
Usability/Label Comprehension	97% of participants comprehended the labeling. 100% of participants used the device successfully. The device is designed for layman understanding and use (OTC).
Adverse Events	No adverse effects found for the predicate device in MAUDE since clearance in 2005 (implies a similarly low risk profile for the applicant device given substantial equivalence).
Operational Method	On/Off switch, no software (similar to predicate). Tabletop device used at 4" distance (differs from predicate's handheld, in-contact use, but power density equivalent is maintained by design).

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

Test Set Description: The primary "test set" described is for a Usability/Label Comprehension Study.
Sample Size: 36 participants.
Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given it's a usability study for an OTC device being submitted for FDA clearance, it would almost certainly be a prospective study conducted within a population relevant to the U.S. market.

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

This type of information is generally not applicable to a usability/label comprehension study. The "ground truth" for this study is essentially the participants' ability to understand instructions and use the device. There's no clinical "ground truth" (e.g., presence of a disease) being established by experts in this context.

4. Adjudication Method for the Test Set

Not applicable to a usability/label comprehension study as described. The outcomes (comprehension percentage, successful use percentage) are direct observations of participant interaction.

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, an MRMC comparative effectiveness study was not done.
This device is a light therapy device for wrinkles, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and "human readers improve with AI vs without AI assistance" are not relevant to this submission.

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

Again, this question is not applicable to
the Rejuvalite MD device. It is a physical light therapy device, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the usability study, the "ground truth" was directly observed user performance and self-reported comprehension. For the broader claim of effectiveness for wrinkle treatment, the device relies on substantial equivalence to a predicate device (LightStim for Wrinkles, K120775) which was presumably established through its own clinical data or literature at the time of its clearance. The Rejuvalite MD itself did not perform independent clinical outcomes data to establish de novo effectiveness.

8. The Sample Size for the Training Set

Not applicable. The Rejuvalite MD is a physical device, not an AI/algorithm that requires a training set.

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

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

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