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The RejuvatoneMD is intended for facial stimulation and is indicated for over-the-counter cosmetic use.

The RejuvatoneMD device is a non-invasive at-home facial stimulation device intended for cosmetic use. The device works by delivering low-level electrical microcurrent impulses through dual contact spheres to strategic locations on the face and allows users to adjust the output level for personalized comfort.

Here's an analysis of the provided text regarding the RejuvatoneMD device's acceptance criteria and studies, organized according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative format for performance of the device in its intended cosmetic use (e.g., "90% of users report improved skin tone"). Instead, the "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to a legally marketed predicate device and compliance with relevant safety and manufacturing standards.

The table below summarizes the technical characteristics comparison between the RejuvatoneMD (Subject Device) and its predicate (NuFACE® Mini Device). For performance specifications like maximum output voltage/current, pulse duration, frequency, etc., the "acceptance" is implied by demonstrating values that are similar to and within an acceptable range of the predicate device, and crucially, comply with IEC 60601-2-10 requirements.

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

• Usability/Label Comprehension Study:
  • Sample Size: 30 participants
  • Data Provenance: Not explicitly stated (e.g., country of origin). The document implies it was a prospective study conducted specifically for this device validation.
• Other Testing (Electrical Safety, Performance, EMC, Biocompatibility): These tests are typically laboratory-based and use technical samples of the device and its components, not human subjects, except for biocompatibility which is tested on materials. No sample size of specific user data is applicable here. The data provenance is laboratory testing against recognized standards.

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

• For the Usability/Label Comprehension Study, the ground truth was based on the participants' ability to correctly self-select, comprehend instructions, and use the device. This "ground truth" is a measure of user understanding and performance, not a clinical diagnosis or expert consensus on clinical outcomes. No external "experts" (like radiologists) are mentioned as establishing ground truth for this usability study. The study itself assesses whether lay users can achieve the intended "truth" of understanding and proper use.
• For the technical standards compliance (Electrical Safety, Performance, EMC, Biocompatibility), the "ground truth" is the established requirements and limits defined by the international consensus standards (IEC, ISO). The experts involved would be the engineers and technicians performing the tests and the standard-setting bodies, not individual experts assessing specific cases.

4. Adjudication Method for the Test Set

• For the Usability/Label Comprehension Study, the "adjudication method" was based on whether participants could "correctly" perform specific tasks. This would have been predetermined criteria defined in the study protocol (e.g., "User correctly identifies appropriate use for the device" or "User correctly selects power level"). It's not an expert adjudication in the sense of clinical disagreement.
• For technical testing, compliance is typically determined by measurements falling within specified ranges or passing defined test procedures. There is no "adjudication" in the clinical sense.

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 MRMC study was done. This device is a direct-to-consumer microcurrent facial stimulator, not an AI-powered diagnostic imaging tool. Therefore, the concept of "human readers improving with AI vs. without AI assistance" is not applicable.

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

• A standalone performance was done, but not in the context of an "algorithm." The core of the submission relies on the standalone electrical and mechanical performance of the device as measured against international safety and performance standards (IEC, ISO). The device's technological characteristics are compared directly to the predicate device. The usability study is also a form of standalone performance assessment – how well does a human user interact with the device as designed.

7. The Type of Ground Truth Used

• Usability/Label Comprehension Study: User performance and comprehension against pre-defined correct actions and understanding gleaned from the labeling.
• Technical Performance (Electrical Safety, EMC, Biocompatibility): Compliance with international consensus standards (IEC, ISO) and comparison of technical specifications to the legally marketed predicate device. This is primarily objective, measurable physical parameters.
• Substantial Equivalence: Comparison to the technological characteristics, intended use, and safety profile of a legally marketed predicate device (K133823 – NuFace Mini).

8. The Sample Size for the Training Set

• Not applicable. This device is hardware for electrical stimulation. There is no "training set" in the machine learning sense. The device's design and parameters are based on established electrical engineering principles and the specifications of predicate devices.

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

• Not applicable, as there is no training set. The "ground truth" for the device's design parameters is derived from engineering principles, safety standards, and established performance of similar predicate devices.

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The HairMD is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa-V and for both, Fitzpatrick Classification of Skin Phototypes of I-IV.

The HairMD consists of 21 red, visible-light, continuous wave diode lasers operating at 650 nanometers and 30 super luminescent light emitting diodes (LEDs), operating at 650 nanometers that are configured within a protective inner liner and outer helmet. The HairMD is physically similar to the iGrow Hair Growth System, except that it does not contain earphones or inner liner spacers. The use of these specific number of diode lasers and LEDs, provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. This is achieved by a safety interlock. At the beginning and end of a therapy session, audible tones are delivered to the user, indicating that therapy has begun (2 beeps) or ended (one long beep). The system is powered by line voltage, operating at 110/220 volts.

The provided text describes a 510(k) premarket notification for the HairMD device, an infrared lamp intended to promote hair growth. However, it explicitly states that "No clinical trial data for the HairMD was submitted for this 510(k)." Therefore, a study proving the device meets acceptance criteria, as well as several of the requested data points (like sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, and training set details), are not available in this document.

The submission focuses on demonstrating substantial equivalence to predicate devices (iGrow Hair Growth System and Hairmax Lasercomb) based on technological characteristics and intended use.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific acceptance criteria or clinical performance data for the HairMD device. It states: "No clinical trial data for the HairMD was submitted for this 510(k)."

However, it does mention that the device was tested for conformance with safety standards.

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: Not applicable, as no clinical trial data was submitted.
• Data Provenance: Not applicable, as no clinical trial data was submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable, as no clinical trial data was submitted and thus no ground truth for a test set was established.

4. Adjudication method for the test set

• Not applicable, as no clinical trial data was submitted.

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 MRMC comparative effectiveness study was done. This device is not an AI-assisted diagnostic tool; it's a therapeutic device.

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

• Not applicable. This device is a therapeutic device, not an algorithm.

7. The type of ground truth used

• Not applicable, as no clinical trial data was submitted. The substantial equivalence argument relies on the established safety and efficacy of the predicate devices and the HairMD's comparable technological characteristics.

8. The sample size for the training set

• Not applicable, as no clinical trial data was submitted for the HairMD device itself. The device is not based on a machine learning model that requires a training set.

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

• Not applicable (see point 8).

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The Rejuvalite MD is an Over the Counter device that is intended for the treatment of full face wrinkles.

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).

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.

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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