(269 days)
The ZIIP Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.
The ZIIP Device is a hand-held, battery-powered device used with conductive gel to stimulate the face superficially through application of transcutaneous electrical currents. It is intended to be used by a single user (multiple applications).
The provided document is a 510(k) premarket notification for the ZIIP Device, a transcutaneous electrical nerve stimulator for pain relief, specifically indicated for facial stimulation and over-the-counter cosmetic use.
Here's an analysis of the acceptance criteria and study information contained within the document:
1. Table of Acceptance Criteria & Reported Device Performance
The acceptance criteria are not explicitly stated as distinct performance targets with pass/fail thresholds. Instead, the document demonstrates substantial equivalence to a predicate device (NuFace Plus Facial Toning Device) by comparing technological characteristics and compliance with recognized standards. The "performance" is implicitly meeting these standards and having comparable specifications to the predicate.
| Acceptance Criteria (Implied) | ZIIP Device Performance (Reported) |
|---|---|
| Safety and Essential Performance | |
| Compliance with IEC 60601-1 (Electrical Safety) | Pass |
| Compliance with IEC 60601-1-2 (Electromagnetic Disturbances) | Pass |
| Compliance with 21 CFR Part 898 (Electrode Lead Wires and Patient Cables) | In compliance |
| Biocompatibility (materials in contact with skin) | Assessed in accordance with ISO 10993 |
| Functional Equivalence to Predicate Device | (Note: Performance here is a comparison to the predicate, not an absolute threshold) |
| Intended Use | Stimulate the Face - Skin Toning (Same as predicate) |
| Indications for Use | Over-the-counter cosmetic use (Same as predicate) |
| Maximum Output Current | 308µA @ 500Ω, 232µA @ 2KΩ, 202µA @ 10KΩ (Comparable to predicate: 274µA @ 500Ω, 387µΑ @ 2ΚΩ, 383μΑ @ 10ΚΩ; ZIIP is within range for safety and efficacy as a microcurrent device) |
| Maximum Output Voltage | 154mV @ 500Ω, 465mV @ 2KΩ, 2.2V @ 10KΩ (Comparable to predicate: 137mV @ 500Ω, 769mV @ 2KΩ, 3.82V @ 10KΩ; ZIIP is within range for safety and efficacy as a microcurrent device) |
| Waveform Shape | Modulated Square Wave (Same as predicate) |
| Other electrical and physical characteristics | Comparable specifications for power source, patient leakage current, number of output channels, automatic overload/no-load trip, automatic shut-off, patient override control, indicator displays, timer range, weight, dimensions, housing material, and requirement for electro-conductive material (all deemed substantially equivalent). |
2. Sample size used for the test set and data provenance
The document does not describe a test set in the context of human subjects or clinical data for performance evaluation. The "testing" refers to bench testing and compliance with electrical safety and EMC standards.
- Test Set Sample Size: Not applicable for clinical performance assessment. The "samples" would be the device units used for engineering tests.
- Data Provenance: Not applicable for clinical performance assessment. The testing was non-clinical (bench testing for electrical safety, EMC, and performance specifications).
3. Number of experts used to establish the ground truth for the test set and their qualifications
This information is not applicable as there was no study involving expert interpretation of data or images to establish a ground truth. The acceptance was based on non-clinical engineering and safety compliance.
4. Adjudication method for the test set
This information is not applicable as there was no test set requiring adjudication in the context of clinical performance or interpretation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, information about effect size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "There was no clinical testing performed in support of this 510(k) submission." Therefore, there is no effect size related to human reader improvement with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm-only performance study was not done. The device is a physical electro-stimulation device, not an AI or software algorithm that provides diagnostic or assistive output.
7. The type of ground truth used
The "ground truth" for the non-clinical testing was established by the specified international and FDA standards (IEC 60601-1, IEC 60601-1-2, 21 CFR Part 898, ISO 10993). Compliance with these standards served as the "ground truth" for safety and electrical performance. For equivalence, the ground truth was the technical specifications of the predicate device (NuFace Plus).
8. The sample size for the training set
This information is not applicable as there was no AI/machine learning component involved in this device submission, and therefore no "training set."
9. How the ground truth for the training set was established
This information is not applicable as there was no AI/machine learning component involved in this device submission, and therefore no "training set" or ground truth for it.
§ 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).