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510(k) Data Aggregation
(57 days)
ZIIP+ Device
The ZIIP+ Device is indicated for facial and neck 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. The device is powered by a Lithium-lon rechargeable battery, and it is shipped with a portable battery charger.
The provided text is a 510(k) Pre-market Notification Summary for the ZIIP+ Device. The document details the device's characteristics, its comparison to predicate devices, and nonclinical testing performed to establish substantial equivalence.
However, the nature of this document (a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator for Pain Relief, used here for facial and neck stimulation for cosmetic use) means that its acceptance criteria and supporting studies are focused on demonstrating substantial equivalence to existing devices through non-clinical performance data, rather than clinical efficacy studies with specific performance metrics like sensitivity, specificity, or reader improvement.
Therefore, I cannot populate a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, because such studies are not typically required or performed for devices demonstrating substantial equivalence through non-clinical data, especially for cosmetic indications under this regulatory pathway.
The “study that proves the device meets the acceptance criteria” here refers to the nonclinical performance testing that demonstrates the ZIIP+ Device is as safe and effective as its predicate devices.
Here's a breakdown of the requested information based on the provided document, highlighting what is (and isn't) present:
1. Table of Acceptance Criteria and Reported Device Performance
(Note: The "acceptance criteria" for a 510(k) submission like this are generally demonstrating compliance with safety standards and functional equivalence to predicates, rather than specific performance metrics for diagnostic accuracy.)
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied from Nonclinical Testing) | Reported Device Performance (Compliance) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 (General requirements for basic safety and essential performance) | Compliant with IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (Electromagnetic disturbances – requirements and tests for radiated and power line conducted emissions) | Compliant with IEC 60601-1-2. |
| Home Healthcare Environment Safety | Compliance with IEC 60601-1-11 (Requirements for medical electrical systems used in the home healthcare environment) | Compliant with IEC 60601-1-11. |
| Software Functionality | Software Verification and Validation to confirm the device meets and complies with applicable software requirements specifications. | Results confirmed that the ZIIP+ Device meets and complies with the applicable software requirements specifications. |
| Biocompatibility | Skin-contacting materials are biocompatible, or identical to a device already determined to be biocompatible. | The skin-contacting materials for ZIIP+ are identical to the skin-contacting materials for the predicate ZIIP device, which was evaluated and determined to be biocompatible. Therefore, the ZIIP+ Device is biocompatible and substantially equivalent. |
| Wireless Coexistence | Compliance with applicable standards for wireless coexistence (implied by inclusion in summary of safety and performance testing results). | Compliant with applicable standards for wireless coexistence. |
| Bench Testing Performance Requirements | Meets bench testing performance requirements (general statement of successful completion of testing). | Meets bench testing performance requirements. |
| Output Characteristics Equivalence | The output characteristics of the ZIIP+ Device are substantially equivalent to the predicate ZIIP device (specifically mentioned for: Power Source, Patient Leakage Current, Number of Output Modules/Channels, Regulated Current/Voltage, Software Control, Automatic Overload/No-Load Trip, Automatic Shut Off, Patient Override Control, Indicator Display). | The ZIIP+ Device has identical output characteristics to the predicate ZIIP device for most listed parameters (e.g., patient leakage current, number of channels, software control, automatic shut-off). Differences with the NuFace Trinity Plus (e.g., waveform, burst mode) are acknowledged but asserted not to raise new questions of safety or effectiveness. |
| Fundamental Technological Characteristics | Demonstrated substantial equivalence in principles of operation, design, and overall technological characteristics. | The ZIIP+ has the identical output characteristics, principles of operation, and treatment method as the predicate ZIIP Device, and essentially the same intended use and technological characteristics as the NuFACE Trinity Plus Device (including BLE). The document concludes that the device is substantially equivalent based on these comparisons and nonclinical testing. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable or not specified in this type of submission. The "test set" here refers to hardware/software units tested against engineering standards, not a patient cohort or imaging dataset.
- Data Provenance: Not applicable. The data provenances are results from laboratory testing (e.g., electrical safety tests, software validation).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth, in the context of this 510(k), is defined by established engineering and medical device safety standards (e.g., IEC standards) and the functional specifications of the device. There are no patient-specific "ground truths" being adjudicated by clinical experts for performance metrics like diagnostic accuracy.
- Qualifications of Experts: Not applicable. Testing would be performed by qualified engineers and technicians in specialized labs.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This is not a clinical study involving human readers or interpretations. Test results are compared against predefined technical specifications and regulatory standards.
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
- MRMC Study: No, an MRMC study was not done. This device is a Transcutaneous Electrical Nerve Stimulator for cosmetic use, not an AI-powered diagnostic imaging device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device's "performance" is its ability to deliver specified electrical currents safely and reliably according to its design and standards, not an algorithm's diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" for this submission are the established international and national standards for medical device safety and performance (e.g., IEC 60601 series, software validation requirements) and the technical specifications of the predicate devices. The claim is substantial equivalence based on meeting these technical benchmarks.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned or implied for an AI/ML model.
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(269 days)
ZIIP Device
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.
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