(315 days)
This device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.
SonicLift (Model: ST261) is a non-invasive facial toning device intended for at-home cosmetic use. It has two treatment modes - Vibration Mode and Micro-current Mode. In the Vibration Mode, mechanical vibration at the frequency of 108.7Hz can help to relax facial muscles. In the Micro-current Mode, the low voltage micro-current impulses are emitted from dual probes that are designed for optimal contact with faces of all shapes and sizes. SonicLift, Model: ST261 allows you to adjust the current output from 0 to 280 microamps for a personalized comfort level.
This document is a 510(k) premarket notification for the Pretika SonicLift, Model ST261. It aims to demonstrate substantial equivalence to predicate devices (NuFace and WAHL FRESH FACE) for facial stimulation and cosmetic use. The document focuses on demonstrating safety and performance through bench testing and comparison to existing standards, rather than a clinical study with specific performance metrics against an established ground truth that would be associated with typical diagnostic AI/ML device submissions.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a physical device (facial stimulator) rather than a diagnostic AI/ML algorithm, the "acceptance criteria" are primarily related to safety and electrical performance standards, and comparison to predicate devices, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC. The "device performance" likewise refers to compliance with these standards and physical characteristics.
| Acceptance Criteria / Test | Specific Criteria | Reported Device Performance / Result |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity Test | Non-toxic ("no more than Grade 2" according to United States Pharmacopoeia for limited skin contacting) | No toxicity to L929 cell. Passed. |
| Skin Sensitization Test | "Grade 0" according to United States Pharmacopoeia for limited skin contacting | Grade 0. Passed. |
| Skin Irritation Test | "0-0.4 for Irritation Index" according to United States Pharmacopoeia for limited skin contacting | 0 for Irritation Index. Passed. |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-2-10 standards. | Comply with IEC 60601-1 and IEC 60601-2-10. Passed. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 standard. | Comply with IEC 60601-1-2. Passed. |
| Software Verification & Validation | Compliance with FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices". | Software verification and validation test conducted. |
| Waveform Test | Verify the output parameters of the device (Frequency, Max Output Voltage, Max Output Current, Net Charge, Pulse Width, Pulse Duration, etc.) in comparison to predicate devices and relevant FDA guidance. The detailed specific values are numerous, but the general criteria is that the differences "will not raise any safety or effectiveness issue" and comply with IEC 60601-2-10 and FDA guidance. | Conducted and verified. Complies with standards. |
| Intended Use | Matching the intended use of predicate devices: facial stimulation for over-the-counter cosmetic use. | "SE" (Substantially Equivalent) to predicate devices. |
| Technological Characteristics | Substantial equivalence to predicate devices in design, functional features, specifications, and materials, particularly regarding electrical and output parameters. Differences should not raise new safety or effectiveness issues. | Various characteristics are compared, with notes explaining substantial equivalence despite minor differences (e.g., power source, number of modes, waveform). |
2. Sample Size Used for the Test Set and Data Provenance
This submission is for a physical device and relies on bench testing and comparison to predicate devices, not an AI/ML algorithm that operates on a "test set" of patient data. Therefore, the concept of a "test set" with a sample size and data provenance in the context of an AI/ML device is not applicable here.
- The biocompatibility tests (Cytotoxicity, Sensitization, Irritation) would have involved specific biological samples (e.g., L929 cells, guinea pigs) as per ISO standards. However, the exact sample sizes for these biological tests are not provided in this summary.
- The electrical safety, EMC, software, and waveform tests are engineering bench tests, not involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. This device is not a diagnostic AI/ML device where "ground truth" for patient data would be established by medical experts for a test set. The "ground truth" for this device's safety and performance is based on compliance with established engineering and biocompatibility standards (IEC, ISO, USP) and comparison to predicate devices, which are defined by regulatory frameworks rather than expert consensus on specific cases.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" of patient data requiring adjudication in the context of an AI/ML diagnostic device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not a diagnostic AI/ML device. MRMC studies are typically used to evaluate the performance of diagnostic devices (often imaging-based AI) compared to human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth," in the context of this device's submission, is compliance with recognized international standards for medical device safety and performance (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, ISO 10993-5, ISO 10993-10), and the demonstrated substantial equivalence to legally marketed predicate devices (NuFace, WAHL FRESH FACE). This is a regulatory "ground truth" rather than a clinical "ground truth" of disease presence/absence.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/ML device that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this 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).