(317 days)
The Nutra Face LIFT Model PE8050 device is intended for facial stimulation and indicated for over-the-counter cosmetic use.
The Nutra Face Lift is a hand-held device intended to apply low level electrical impulses to strategic locations on the face. The Nutra Face Lift probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings from 0 to 400 microamps for personalized comfort level by pressing the up/down button. The Nutra Face Lift requires the use of a conductive derma gel.
The Nutra Face Lift unit contains a power supply and internal Ni-MH rechargeable battery. The enclosure is made of medical grade biocompatibility plastics and the output contacts (Probes) consist of chrome-plated spheres. The on/off button on the unit directly allows the user to immediately remove all power from the unit.
The provided document, a 510(k) summary for the "Nutra Face LIFT Model PE8050", primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about the acceptance criteria for a specific performance study in the way a clinical trial might, nor does it present the study for proving those criteria.
However, it does describe a "Usability and Product Self Selection Study" and states that "All four goals of the Study were met." This implies that the 'acceptance criteria' for this specific study were the successful achievement of these stated goals. The document also mentions nonclinical performance data related to compliance with FDA performance standards and electrical safety.
Here's an analysis based on the provided text, addressing your questions where possible:
Description of Acceptance Criteria and Study
The primary study mentioned, the "Usability and Product Self Selection Study," had four goals that served as its acceptance criteria. The document states that all four goals were met, thereby proving the device met these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Study Goals) | Reported Device Performance |
|---|---|
| 1. To attract participants that represented the "intended users" of the device. | Met |
| 2. To determine if consumers could correctly self-select using the Packaging labeling only. | Met |
| 3. To test consumer knowledge of the Packaging labeling and Instruction Manual. | Met |
| 4. To have consumers demonstrate their ability to adhere to what they had read in the Instruction Manual and actually operate and care for the device correctly. | Met |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 80 participants
- Data Provenance: Not explicitly stated, but the submission is to the US FDA, suggesting the study was likely conducted in the United States. The study is referred to as a "Usability and Product Self Selection Study," indicating a prospective design where data was collected specifically for this evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish a 'ground truth' in the context of this Usability and Product Self Selection Study. The study focused on consumer interaction, self-selection, and knowledge, not on expert medical evaluation of outcomes.
4. Adjudication Method for the Test Set
Not applicable for this type of self-selection and usability study. The criteria were based on participants' actions and knowledge, which would likely have been directly observed or assessed.
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. The device is a "Transcutaneous electrical nerve stimulator for pain relief" (classified as such, but indicated for "facial stimulation and is indicated for-over-the counter cosmetic use"), not an AI-powered diagnostic tool requiring human reader interpretation of cases.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done
This is not applicable, as the device is a physical electrostimulation device for cosmetic use, not an algorithm. Its performance is evaluated through its physical and electrical characteristics, and user interaction.
7. The Type of Ground Truth Used
For the "Usability and Product Self Selection Study," the "ground truth" was essentially the observed behavior and stated understanding of the participants regarding the device's packaging and instruction manual, and their ability to operate the device correctly. This is a form of behavioral or self-reported data against pre-defined success metrics for usability and comprehension.
The document also mentions compliance with various engineering and electrical safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ISO 10993) for which the "ground truth" would be the successful adherence to the requirements of these published technical standards, verified through objective laboratory testing.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML 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.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).