(139 days)
Nu Skin RenuSpa iO is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.
Nu Skin RenuSpa iO is a hand-held, portable, rechargeable microcurrent device used to stimulate certain parts of the body for aesthetic purposes. It is used with a conductive medium. It contains a rechargeable Lithium-ion battery that is recharged with a USB-enabled inductive charger. Nu Skin RenuSpa iO is inductively charged by the supplied Nu Skin RenuSpa iO charging stand. Nu Skin RenuSpa iO is designed to mechanically rest on the charging stand in a manner that ensures proper alignment for charging. The charging stand connects to an external AC/DC USB Power supply adapter via a short length of cable terminated with USB-A Male connection. Nu Skin RenuSpa iO is indicated for use only on healthy, unbroken skin. Nu Skin RenuSpa iQ uses a combination of LED lights and audio feedback. Nu Skin RenuSpa iO is sold in the United States in a kit with the conductive medium (510k cleared conductive GEL K022006). In all cases the Nu Skin RenuSpa iO and Charger user manual are provided to the user.
The provided text describes the 510(k) summary for the Nu Skin RenuSpa iO device, which is intended for body skin stimulation for over-the-counter cosmetic use. This document focuses on demonstrating substantial equivalence to a predicate device (NuBODY Skin Toning Device) rather than presenting a study proving that the device meets specific clinical acceptance criteria in terms of performance on patients.
Therefore, a significant portion of the requested information regarding clinical studies, sample sizes, expert ground truth, adjudication methods, and MRMC studies, is explicitly stated as "Not applicable" or is not present in the provided document, as the submission relies on nonclinical (bench) testing to demonstrate substantial equivalence.
Here's the information that can be extracted and a clear indication where the requested information is not available:
1. A table of acceptance criteria and the reported device performance
The document provides a table of "Design Verification" tests with a "Conclusion" column indicating "Acceptance criteria met." However, the specific numerical acceptance criteria for each test (e.g., what constitutes meeting "dimensional specifications" or "electrical functionality") are not detailed, only the qualitative conclusion. The reported device performance is similarly described qualitatively as meeting these unspecified criteria.
| Test | Test Method Summary | Reported Device Performance / Conclusion |
|---|---|---|
| Dimension verification | Confirms the units meet all dimensional specifications | Acceptance criteria met |
| Visual Inspection | Confirms the product meets all visual specifications | Acceptance criteria met |
| Design Verification | Confirms functionality of units using a clinically relevant bench top model | Acceptance criteria met |
| Software (SW) V&V | Confirms the units meet all SW specifications | Acceptance criteria met |
| Electrical Testing | Confirms electrical functionality of units using a clinically relevant bench top model | Acceptance criteria met |
| Biocompatibility | Confirms the units meet all biocompatibility requirements for this type of device | Acceptance criteria met |
| Cleaning Method Validation | Confirms the units meet all cleaning method expectations for this device | Acceptance criteria met |
| Packaging Distribution Simulation and accelerated aging Testing | Confirms the units meet all packaging distribution simulation and aging requirements | Acceptance criteria met |
| Output Waveform Characteristics | Nonclinical testing against predicate (NuBODY) | Substantially equivalent |
| Output Energy Characteristics | Nonclinical testing against predicate (NuBODY) | Substantially equivalent |
| Electrical and Constructional Safety (IEC 60601-1) | Nonclinical testing of the Nu Skin device | Conformed to standard |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2) | Nonclinical testing of the Nu Skin device | Conformed to standard |
| Specifics for Maximum Output Voltage (22 VDC) | Bench testing | 22 VDC |
| Specifics for Maximum Output Current (640 uA) | Bench testing (at 0Ω impedance, 620uA at 500Ω) | 640 uA |
| Specifics for Maximum Output Current Density (0.320 mA/cm²) | Calculated using the same methodology as predicate | 0.320 mA/cm² |
| Specifics for Net Charge per pulse (38.4 uC) | Calculated using the same methodology as predicate | 38.4 µC |
| Specifics for Maximum Average Power Density (3.52 mW/cm²) | Calculated using the same methodology as predicate | 3.52 mW/cm² |
| Specifics for Maximum Phase Charge (0.768 mC/Burst) | Calculated using the same methodology as predicate | 0.768 mC/Burst |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document explicitly states "Clinical Testing: Not applicable." The nonclinical "test set" for the bench testing is described as a "production equivalent of the Nu Skin" and a "commercial unit of the predicate." The exact number of units tested is not specified, but it implies a small number for bench validation.
- Data Provenance: Not specified for nonclinical testing.
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)
Not applicable, as no clinical studies with expert-established ground truth were performed for this submission. The "ground truth" for the nonclinical tests would be the established engineering specifications and compliance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies requiring adjudication were performed.
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
Not applicable. This device is a transcutaneous electrical nerve stimulator for cosmetic use, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithmic device. The device itself is a standalone product (without human-in-the-loop performance in terms of interpretation, but obviously requires human application). The performance was evaluated through nonclinical laboratory tests.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the nonclinical testing, the "ground truth" is implied to be the engineering design specifications, established industry standards (e.g., IEC 60601 series), and the characteristics of the legally marketed predicate device.
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device requiring a training set.
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).