(117 days)
Intended for facial stimulation and indicated for over-the-counter cosmetic use.
The PureLift Pro Edition device is a hand-held device intended to apply electrical impulses to strategic locations on the face. The device probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allow the user to adjust the settings for personalized comfort level by pressing the up/down button. The intensity starts at (1) and continues to (10). The device measures 20.7cm (H) x 4.8cm (W) x 4.5cm (D). The outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device is powered by a 3.7-volt battery which produce a low-level current that is transmitted through the two fixed, smooth spherical probes. To turn the device on, the power button is pushed. Then the green LED light will illuminate indicating the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face of conductive gel. The PureLift Pro Edition unit contains a power supply and rechargeable battery. The enclosure is made of medical grade biocompatible plastics and the output contacts (Probes) consist of chrome-plated spheres.
This document is a 510(k) premarket notification for the PureLift Pro Edition device. It states that no new performance data was required to establish substantial equivalence for the main device. However, performance data was generated for the PureLift Activator Serum, an accessory conductive gel, to demonstrate its equivalence to a predicate conductive gel.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
For the PureLift Pro Edition device itself, the document explicitly states: "No new or repeat design verification or design validation was required to support the substantial equivalence of the PureLift Pro Edition stimulator." This implies that the acceptance criteria for the device itself were based on its identity to the predicate device in terms of intended use and primary technological characteristics, and no new performance data was thus generated in this submission.
For the PureLift Activator Serum (accessory conductive gel), the acceptance criteria and performance are indicated in the "Performance Testing" section.
| Acceptance Criteria (for PureLift Activator Serum) | Reported Device Performance (PureLift Activator Serum) |
|---|---|
| Similar Conductivity to Predicate Gel | "The analysis demonstrated that the PureLift Activator Serum has similar conductivity as the Lectron II conductive gel." |
| Biocompatibility (Non-cytotoxic) | "Biocompatibility evaluations confirmed that the PureLift Activator Serum is non-cytotoxic..." (based on ISO 10993-5) |
| Biocompatibility (Non-sensitizing) | "...non-sensitizing..." (based on ISO 10993-10) |
| Biocompatibility (Non-irritating) | "...and non-irritating." (based on ISO 10993-10) |
| Max Voltage (similar to predicate) | Listed as "Comparisons to the Predicate Gel: • Maximum Voltage" in the performance testing section, indicating it was compared, but no specific value or "acceptance criteria" for similarity is explicitly stated as a numerical threshold in this document. The conclusion is that differences "did not raise new questions of safety or effectiveness." |
| Max Current (similar to predicate) | Listed as "Comparisons to the Predicate Gel: • Maximum Current" in the performance testing section, indicating it was compared, but no specific value or "acceptance criteria" for similarity is explicitly stated as a numerical threshold in this document. |
| Frequency (similar to predicate) | Listed as "Comparisons to the Predicate Gel: • Frequency" in the performance testing section, indicating it was compared, but no specific value or "acceptance criteria" for similarity is explicitly stated as a numerical threshold in this document. |
| Pulse Width (similar to predicate) | Listed as "Comparisons to the Predicate Gel: • Pulse Width" in the performance testing section, indicating it was compared, but no specific value or "acceptance criteria" for similarity is explicitly stated as a numerical threshold in this document. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not provide details on sample sizes for the conductivity analysis or biocompatibility testing of the PureLift Activator Serum. It broadly states "An analysis of the conductivity testing... was performed" and "Biocompatibility evaluations... were conducted."
The data provenance is not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The performance data for the PureLift Activator Serum (conductivity and biocompatibility) would typically be generated through laboratory testing, not through expert consensus on a test set in the way a diagnostic AI product might be evaluated.
4. Adjudication Method for the Test Set
Not applicable. This type of adjudication (e.g., 2+1, 3+1) is typically relevant for studies involving human interpretation or expert scoring, which is not the case for the reported performance data for this device or its accessory.
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 is not mentioned. This type of study is relevant for AI-powered diagnostic or assistive technologies, which the PureLift Pro Edition (a transcutaneous electrical nerve stimulator for cosmetic facial stimulation) is not. The submission is a 510(k) for a physical device, and the "AI" or "firmware" mentioned is likely internal control software, not an AI for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not applicable or performed, as this device is a physical stimulator and not an AI algorithm for data interpretation. The software/firmware is for controlling the device's electrical impulses.
7. The Type of Ground Truth Used
For the PureLift Activator Serum:
- Conductivity: The ground truth would be the measured conductivity values themselves, compared against the predicate gel's measured conductivity.
- Biocompatibility: The ground truth is established through standardized biological evaluations (ISO 10993-5 for cytotoxicity, ISO 10993-10 for sensitization and irritation), producing objective results based on cellular or tissue responses.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that undergoes a training phase with a "training set" of data in the common machine learning sense. The device is a hardware product.
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).