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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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