(201 days)
PureLift is intended for facial stimulation and indicated for over-the-counter cosmetic use.
The PureLift is a hand-held device intended to apply electrical impulses to strategic locations on the face. The PureLift 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 (1) and continues to (10). The device measures 13.4″ L x 4.8″ W x 4.3″ 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 LCD screen will be displayed, 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. PureLift is intended to be used with a legally marketed electroconductive media. The PureLift 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.
The provided document is a 510(k) summary for the PureLift device, a transcutaneous electrical nerve stimulator for aesthetic purposes. However, it does not contain a study that directly proves the device meets specific acceptance criteria for its intended cosmetic use (facial stimulation for over-the-counter cosmetic use).
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (NuFace K072260 and reference device Rejuvenique K011935) by comparing technological characteristics and presenting results of various safety and performance tests. These tests are primarily designed to ensure the device is safe and functions as intended from an engineering and biocompatibility standpoint, rather than proving its cosmetic efficacy against specific clinical acceptance criteria.
Therefore, many of the requested details, such as sample size for test sets directly assessing cosmetic efficacy, expert-established ground truth for cosmetic outcomes, MRMC studies, or standalone performance for cosmetic claims, are not present in this regulatory submission.
Here's an attempt to answer the questions based only on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for cosmetic efficacy experiments or performance directly related to its "facial stimulation" claim. Instead, it details various engineering and safety tests and states that the device "passed or met the requirements of all testing." The table below will reflect the tests conducted and their outcomes as reported.
| Acceptance Criteria (Stated as "Requirements") | Reported Device Performance |
|---|---|
| Biocompatibility | |
| - Cytotoxicity (passed) | Not cytotoxic |
| - Sensitization (passed) | Not sensitizing |
| - Irritation (passed) | Not irritating |
| Electrical Safety | |
| - Compliance with IEC 60601-1 | Complied |
| - Compliance with IEC 60601-1-11 | Complied |
| - Compliance with IEC 60601-2-10 | Complied |
| Electromagnetic Compatibility (EMC) | |
| - Compliance with IEC 60601-1-2 | Complied |
| Software Verification & Validation | |
| - Per FDA Guidance (moderate level of concern) | Testing conducted and documentation provided as recommended. |
| Additional Physical/Mechanical Tests | |
| - Oscilloscope tracings | Passed/Met requirements |
| - Vibration | Passed/Met requirements |
| - Temperature | Passed/Met requirements |
| - Push | Passed/Met requirements |
| - Mold Stress | Passed/Met requirements |
| - Markings | Passed/Met requirements |
| - Mechanical Strength | Passed/Met requirements |
| - Drop | Passed/Met requirements |
| - Ball | Passed/Met requirements |
| - Acoustic | Passed/Met requirements |
| - Accessible Parts | Passed/Met requirements |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions various tests (biocompatibility, electrical safety, EMC, software V&V, and other physical/mechanical tests) but does not specify the sample size for these tests. For biocompatibility, it states "The subject device is considered tissue contacting for a duration of less than 24 hours," which refers to the classification of contact, not a sample size.
The data provenance (country of origin, retrospective/prospective) is not provided. These are typically laboratory tests performed on device units.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as the regulatory submission focuses on engineering, safety, and performance standards rather than clinical efficacy studies requiring expert evaluation of "ground truth" for cosmetic outcomes. The "ground truth" for the tests mentioned (e.g., biocompatibility or electrical safety) would be established by the testing standards themselves and laboratory measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant for clinical studies with subjective endpoints, which are not detailed in this 510(k) summary for engineering and safety tests.
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 MRMC comparative effectiveness study was done and therefore no effect size for human improvement with AI assistance is reported. This device is a direct-to-consumer electrical stimulator, not an AI-powered diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the PureLift device is a physical electromedical device for facial stimulation, not an AI algorithm. Software verification and validation were performed for the device's control software, but this is distinct from AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the reported performance data:
- Biocompatibility: The ground truth is established by adherence to ISO 10993 standards and the results of laboratory tests (cytotoxicity, sensitization, irritation) which provide objective measures against established biological criteria.
- Electrical safety and EMC: The ground truth is established by compliance with IEC 60601 series standards, using objective measurements against specified electrical and electromagnetic limits.
- Software Verification and Validation: The ground truth is established by adherence to FDA guidance for software in medical devices, typically involving testing against software requirements and design specifications.
- Other physical/mechanical tests: The ground truth is established by meeting engineering specifications and performance limits for durability, function, etc.
For the cosmetic use indication, the document does not describe any studies that would establish a specific "ground truth" for cosmetic outcomes like facial toning or appearance improvement. The 510(k) process focuses on substantial equivalence based on technical characteristics and safety, assuming the predicate's indications are well-established.
8. The sample size for the training set
This information is not applicable/not provided. The device is a physical electrical stimulator, not a machine learning model that requires a training set for an algorithm.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated in point 8.
§ 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).