(156 days)
Intended for facial stimulation and indicated for over-the-counter cosmetic use.
The PureLift Pro Plus is a hand-held device intended to apply electrical impulses to strategic locations on the face. The PureLift Pro Plus 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 for personalized comfort level by pressing the up/down button. The intensity starts at (10).
The device measures 20.7cm (H) x 4.8cm (W) x 4.5cm (D). Its outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device, powered by a 3.7-volt battery, produces 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 with the use of conductive gel.
The PureLift Pro Plus 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.
Here's a breakdown of the acceptance criteria and study information for the PureLift Pro Plus, based on the provided FDA 510(k) summary:
This device is an electrical stimulator for aesthetic purposes, not an AI/ML device, so many of the requested fields (like those pertaining to AI model performance, human reader studies, or training sets) are not applicable (N/A) in this context. The acceptance criteria and performance data described relate to the safety and electrical/mechanical integrity of the physical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Standards Met | Reported Device Performance | Comments |
|---|---|---|---|
| Mechanical/Physical | Established design specifications | Met specifications | Verified through oscilloscope tracings, vibration, temperature, push, mold stress, markings, mechanical strength, drop, ball, and acoustic testing. |
| Biocompatibility | ISO 10993-1 (Cytotoxicity) | Passed | Not cytotoxic. |
| ISO 10993-1 (Sensitization) | Passed | Not sensitizing. | |
| ISO 10993-1 (Irritation) | Passed | Not irritating. | |
| Electrical Safety | ANSI/AAMI ES60601-1 | Compliant | |
| IEC 60601-1-11 | Compliant | ||
| IEC 60601-2-10 | Compliant | ||
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Compliant | |
| Software | Established design specifications | Met specifications | Verified through software verification and validation testing, assigned "moderate" level of concern. |
| Output Electrical Parameters (Comparison to Predicate/Reference) | Maximum output voltage/current within acceptable safety margins compared to predicate and reference, and below IEC standards for energy per second. | Verified as safe | Differences in voltage/current, phase charge, current density, and power density were evaluated and found not to adversely impact safety or effectiveness, remaining below thresholds for harm (e.g., 0.25 W/cm² for burn risk). |
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated regarding a "test set" in the context of an algorithm. The testing described (mechanical, biocompatibility, electrical, software) would typically apply to representative device units from production, not a dataset of patient cases. The document implies performance testing was done on the device itself.
- Data Provenance: N/A for data provenance as it's not a data-driven device; the results are from laboratory testing of the physical hardware and software.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable, as this is not an AI/ML diagnostic or predictive device requiring expert interpretation of results to establish ground truth. The "ground truth" here is compliance with engineering standards and safety limits, which is assessed through defined testing procedures performed by qualified engineers/technicians.
- Qualifications of Experts: N/A.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. The "test set" in this context refers to physical device units undergoing compliance and safety testing, not a dataset requiring human adjudication of labels or interpretations.
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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:
- MRMC Study: No. This device is a transcutaneous electrical nerve stimulator for aesthetic purposes, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. While the device has software/firmware control, its function is direct electrical stimulation, and it's not an algorithm providing a diagnostic or predictive output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: The ground truth for this device's performance is adherence to established engineering standards (e.g., IEC 60601 series, ISO 10993 series), design specifications, and safety limits. This is determined through objective measurements and validated test methods, not clinical outcomes or expert consensus on a disease state.
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This device does not use machine learning, so there is no "training set."
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. No training set is used.
§ 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).