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Nu Skin RenuSpa iO is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.

Nu Skin RenuSpa iO is a hand-held, portable, rechargeable microcurrent device used to stimulate certain parts of the body for aesthetic purposes. It is used with a conductive medium. It contains a rechargeable Lithium-ion battery that is recharged with a USB-enabled inductive charger. Nu Skin RenuSpa iO is inductively charged by the supplied Nu Skin RenuSpa iO charging stand. Nu Skin RenuSpa iO is designed to mechanically rest on the charging stand in a manner that ensures proper alignment for charging. The charging stand connects to an external AC/DC USB Power supply adapter via a short length of cable terminated with USB-A Male connection. Nu Skin RenuSpa iO is indicated for use only on healthy, unbroken skin. Nu Skin RenuSpa iQ uses a combination of LED lights and audio feedback. Nu Skin RenuSpa iO is sold in the United States in a kit with the conductive medium (510k cleared conductive GEL K022006). In all cases the Nu Skin RenuSpa iO and Charger user manual are provided to the user.

The provided text describes the 510(k) summary for the Nu Skin RenuSpa iO device, which is intended for body skin stimulation for over-the-counter cosmetic use. This document focuses on demonstrating substantial equivalence to a predicate device (NuBODY Skin Toning Device) rather than presenting a study proving that the device meets specific clinical acceptance criteria in terms of performance on patients.

Therefore, a significant portion of the requested information regarding clinical studies, sample sizes, expert ground truth, adjudication methods, and MRMC studies, is explicitly stated as "Not applicable" or is not present in the provided document, as the submission relies on nonclinical (bench) testing to demonstrate substantial equivalence.

Here's the information that can be extracted and a clear indication where the requested information is not available:

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

The document provides a table of "Design Verification" tests with a "Conclusion" column indicating "Acceptance criteria met." However, the specific numerical acceptance criteria for each test (e.g., what constitutes meeting "dimensional specifications" or "electrical functionality") are not detailed, only the qualitative conclusion. The reported device performance is similarly described qualitatively as meeting these unspecified criteria.

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

• Sample Size for Test Set: The document explicitly states "Clinical Testing: Not applicable." The nonclinical "test set" for the bench testing is described as a "production equivalent of the Nu Skin" and a "commercial unit of the predicate." The exact number of units tested is not specified, but it implies a small number for bench validation.
• Data Provenance: Not specified for nonclinical testing.

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, as no clinical studies with expert-established ground truth were performed for this submission. The "ground truth" for the nonclinical tests would be the established engineering specifications and compliance standards.

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

Not applicable, as no clinical studies requiring adjudication were performed.

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

Not applicable. This device is a transcutaneous electrical nerve stimulator for cosmetic use, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is not an algorithmic device. The device itself is a standalone product (without human-in-the-loop performance in terms of interpretation, but obviously requires human application). The performance was evaluated through nonclinical laboratory tests.

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

For the nonclinical testing, the "ground truth" is implied to be the engineering design specifications, established industry standards (e.g., IEC 60601 series), and the characteristics of the legally marketed predicate device.

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device requiring a training set.

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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The Buzz Facial Toning System is an Over-The-Counter handheld device indicated for cosmetic use.

The Buzz Facial Toning System is a TENS device that applies an electrical current to electrodes on a person's skin for aesthetic purposes.

The provided 510(k) summary for "The Buzz Facial Toning System" does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Here's why and what can be extracted from the document:

Why the requested information is largely absent:

• Substantial Equivalence Pathway: This 510(k) application is based on substantial equivalence to existing predicate devices (K011935, K040871, K072260, K070217, K070250, K071573). This pathway typically does not require new clinical performance studies to demonstrate safety and effectiveness if the device is sufficiently similar to legally marketed devices.
• "Cosmetic Use" Indication: The device is indicated for "cosmetic use." Devices for cosmetic purposes often have less rigorous performance study requirements compared to devices making medical claims (e.g., treating a disease, diagnosing a condition).
• Explicitly Stated "N/A" for Performance Testing: The document explicitly states "N/A" (Not Applicable) for "Performance Testing - Bench," "Performance Testing - Animal," and "Performance Testing - Clinical." This confirms that specific performance studies, as one might expect for a new medical claim or a device not relying on substantial equivalence for performance, were not conducted or submitted.

Despite the lack of a traditional performance study, I will structure the answer based on your request, explaining why certain sections are empty and what little information is available.

Acceptance Criteria and Study for The Buzz Facial Toning System

The 510(k) summary for "The Buzz Facial Toning System" does not present specific acceptance criteria or a dedicated study to prove the device meets these criteria in terms of performance for its stated cosmetic indication. The submission relies on demonstrating substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. No dedicated clinical or performance test set was used, as performance was established through substantial equivalence.
• Data Provenance: Not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. There was no clinical study requiring expert assessment for ground truth establishment.

4. Adjudication Method

• Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC comparative effectiveness study was not conducted. The submission specifically states "Performance Testing - Clinical - N/A."

6. Standalone Performance Study (Algorithm Only)

• No. A standalone performance study was not conducted for the device. The device is a physical TENS device, not an algorithm, and its performance was not evaluated independently of human use in a specific study within this submission.

7. Type of Ground Truth Used

• Not applicable for performance. The "ground truth" for the device's marketability and safety was based on the regulatory precedent of the predicate devices a.k.a. Substantial Equivalence. For biocompatibility, the ground truth was the established safety of the materials and a legally marketed predicate conductive gel.

8. Sample Size for the Training Set

• Not applicable. As no new performance study was conducted, there was no "training set."

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

• Not applicable.

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