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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.

AI/ML Overview

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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