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The Nutritone™ Facial Beauty System is intended to stimulate the face. The device is indicated for cosmetic use.

The Nutritone™ Facial Beauty System is a battery-powered hand-held non-prescription device. Its output is a series of electrical pulses that are delivered to the user's face via electrodes that are built into the body of the device.

This 510(k) summary (K070250) for the Nutritone™ Facial Beauty System does not contain information about acceptance criteria or a dedicated study to prove the device meets specific performance criteria.

Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Face Master Facial Toning System, K040871). This means the manufacturer argues that their new device is as safe and effective as the predicate device, primarily by comparing their intended use and technological characteristics.

Therefore, many of your requested points cannot be answered based on the provided text, as they pertain to a type of performance study that was not conducted or documented here.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document focuses on a comparison of specifications between the new device and the predicate device, not on pre-defined acceptance criteria for performance or a study demonstrating achievement of those criteria.

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

This information is not applicable/provided. No "test set" in the context of a performance study is mentioned. The submission is based on a comparison of device specifications, not on clinical performance data derived from a test set.

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

This information is not applicable/provided. Ground truth, in the context of a clinical study, is not established because no such study is described. The "ground truth" for this submission is the established safety and efficacy of the predicate device.

4. Adjudication Method for the Test Set

This information is not applicable/provided. No test set or clinical performance data requiring adjudication is presented.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided document. The device is a "Stimulator, Transcutaneous Electrical, for Cosmetic Use," which typically doesn't involve image interpretation by human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

This information is not applicable/provided. The device is a physical, battery-powered hand-held stimulator; there are no "algorithms" in the sense of AI or software-only performance that would undergo a standalone performance study. The document explicitly states "Software or microprocessor: None is used".

7. Type of Ground Truth Used

The "ground truth" implicitly used for this submission is the established regulatory clearance and presumed safety and effectiveness of the legally marketed predicate device (Face Master Facial Toning System, K040871).

8. Sample Size for the Training Set

This information is not applicable/provided. There is no mention of a training set as would be used for an AI/ML algorithm. The device does not utilize software or a microprocessor for AI or machine learning.

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

This information is not applicable/provided for the same reasons as point 8.

Summary of the 510(k) Approach:

The K070250 submission for the Nutritone™ Facial Beauty System is a substantial equivalence (SE) submission. This regulatory pathway primarily involves demonstrating that a new device is as safe and effective as a predicate device that is already legally marketed. The evidence provided is a detailed comparison of the new device's intended use and technological characteristics (electrical properties, materials, design, etc.) to those of the predicate device. The conclusion explicitly states: "Since the intended use is the same and the technological characteristics are so similar we believe that this pre-market submission demonstrates substantial equivalence (SE) to a legally marketed predicate device." This approach does not typically require new clinical studies with defined acceptance criteria or ground truth establishment in the way an AI/ML device might.

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