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510(k) Data Aggregation
(645 days)
The Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device is indicated for over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation.
Candidate device is a handheld, AA battery-operated portable device for use in the home or clinic. It has pre-set modes and is for over-the-counter use in the home or a clinical setting. The candidate device uses transcutaneous electrical stimulation (TENS) for aesthetic use for facial, neck, and body stimulation. The EZZI-LIFT device has built-in electrodes. Accessories, listed below, are also available to be used with the device.
The Avazzia OTC TENS for Aesthetics, model BEST-AV1: EZZI-LIFT Device did not have a clinical study that proves the device meets acceptance criteria for a specific clinical outcome. Instead, the device's substantial equivalence was established through non-clinical bench testing, performance testing, and a comparison of its technical characteristics to predicate devices.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal "acceptance criteria" table with specific quantitative thresholds for clinical performance. Instead, it demonstrates substantial equivalence by comparing the technical specifications of the candidate device (EZZI-LIFT) to its predicate devices (NuFACE Trinity and NuBODY Skin Toning Device) and by confirming compliance with relevant safety standards.
The comparison table provided in the document highlights the following characteristics:
| Characteristic | Units | Candidate (EZZI-LIFT) | Primary Predicate (NuFACE Trinity) | Secondary Predicate (NuBody) |
|---|---|---|---|---|
| Device Name | EZZI-LIFT | NuFACE Trinity | NuBody | |
| 510K | K191951 | K181008 | K171588 | |
| Manufacturer | Avazzia, Inc. | Carol Cole Company (dba NuFACE) | Carol Cole Company (dba NuFACE) | |
| Indications for Use | Over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation. | Facial and neck stimulation; over-the-counter cosmetic use. | Body skin stimulation; over-the-counter cosmetic use. | |
| Anatomic Sites | Face, neck, and body | Face and neck | Body | |
| Number of Output Modes | number | 4 | 1 | 1 |
| Low Battery Indicator | Yes | Yes | Yes | |
| Automatic shut off | (minutes) | 60 | 20 | 5 |
| Compliance with Voluntary Standards | Yes/No | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, IEC 62366 | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60529, ISO 14971, IEC 60601-1-6, IEC 62366 |
| Compliance with 21 CFR 898 | Yes / No | Yes | Yes | Yes |
| Weight | ounces | 5.4 | 9 | 10 to 14 |
| Dimensions [W x H x D] | (in.) | 2.6" X 4.7" X 1.35" | 2.8" x 5.1" x 1.3" | 2" x 6.5" x 6.0" |
| Housing Materials and Construction | PCBs inside plastic case housing | Thermoplastic | Thermoplastic | |
| User Interface Display | LEDs and switches | not publicly available | not publicly available | |
| Energy type | Electric stimulation | Electric stimulation | Electric stimulation | |
| Number, Size, and Type of Batteries | Two 1.5 V AA batteries | Internal rechargeable Lithium-ion battery | Internal rechargeable Lithium-ion battery | |
| Stimulation Output Specifications | ||||
| Waveform Shape | positive square wave followed by a damped sinusoidal waveform of variable duration | pulsed biphasic modulated square wave | monophasic voltage modulated square wave | |
| Max output voltage (+/- 20%) at 500 Ω | V | -42 | 28 | 28 |
| Max output voltage (+/- 20%) at 2,000 Ω | V | -122 | not publicly available | not publicly available |
| Max output voltage (+/- 20%) at 10,000 Ω | V | -348 | not publicly available | not publicly available |
| Max output current (+/-20%) at 500 Ω | μA | 363 | 400 | 900 |
| Max output current (+/-20%) at 2,000 Ω | μA | 117 | not publicly available | not publicly available |
| Max output current (+/-20%) at 10,000 Ω | μA | 38 | not publicly available | not publicly available |
| Duration of primary (depolarizing phase) | mSec | 0.5 | 60 | 60 |
| Pulse Duration | mSec | 1.1 | 60 | 60 |
| Frequency | Hz | 15 to 121 | 8.3 | 8.3 |
| Net Charge per pulse at 500 Ω | μC | 4 | not publicly available | 54 |
| Max phase charge | μC | 10 | not publicly available | not publicly available |
| Max current density at 500 Ω (Built-in, Y, Brush) | μΑ/cm² | 800 | 419 | 468 |
| Max current density at 500 Ω (Pencil) | μΑ/cm² | 19,000 | ||
| Max average power density at 500 Ω (Built-in, Y, Brush) | μW/cm² | 500 | not publicly available | 4,180 |
| Max average power density at 500 Ω (Pencil) | μW/cm² | 3,500 | ||
| Burst mode (a) pulse per burst | number | 1 | 20 | 20 |
| Burst mode (b) burst per second | number | n/a | 8.3 | 8.3 |
| Burst mode (c) burst duration | (sec) | n/a | 2.4 | 2.4 |
| Burst mode (d) duty cycle | n/a | 20.2sec | 20.2sec | |
| On Time (per second) | seconds | 0.1 | not publicly available | not publicly available |
| Off Time (per second) | seconds | 0.9 | not publicly available | not publicly available |
| Electrodes (a) materials | Stainless steel 316 | Chrome-plated | Chrome-plated | |
| (b) electroconductive media | n/a | Conductive gel | Conductive gel | |
| (c) electrode-to-skin impedance range | less than 15 | not publicly available | not publicly available | |
| (d) max duration of use (same as device shut off) | (minutes) | 60 | 20 | 20 |
| (e) conductive surface area (built in rectangular) | cm2 | 1.94 | - | - |
| (e) conductive surface area (spherical) | cm2 | 5.60 | not publicly available | not publicly available |
| (e) conductive surface area (brush/comb) | cm2 | 0.56 | not publicly available | not publicly available |
| (e) conductive surface area (small circular, pencil-like) | cm2 | 0.023 | not publicly available | not publicly available |
The acceptance criterion, though not explicitly stated as a pass/fail threshold, is implied to be that the device's technical characteristics, particularly regarding stimulation output and safety features, fall within the range of equivalence to predicate devices and comply with accepted safety standards (e.g., ANSI/AAMI NS4:2013/(R)2017). The document explicitly states: "The candidate devices fall within the same range of equivalence for performance and energy output for meeting the ANSI/AAMI NS4:2013/(R)2017 standard requirements for safety; and therefore, they do not raise new questions of safety."
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 primarily describes non-clinical bench testing and usability studies, not traditional clinical trials with patient test sets. Therefore, terms like "sample size for the test set" (in a clinical context) and "data provenance" (country of origin, retrospective/prospective) are not directly applicable.
- Test Set (Non-clinical): The "test set" for performance testing consisted of "a production equivalent of the candidate device." The specific number of devices tested is not mentioned.
- Usability Study: A usability study was performed, but the number of participants or their demographics are not provided.
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 applicable as the clearance was based on substantial equivalence to predicate devices and non-clinical testing, rather than a study requiring expert consensus on clinical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the clearance was based on non-clinical testing and comparison to predicate devices, which do not involve adjudication by multiple experts on a clinical test set.
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
There was no MRMC comparative effectiveness study done. This device is a Transcutaneous Electrical Nerve Stimulator (TENS) for aesthetic use, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is not an algorithm or AI-based system. It's a hardware device (TENS stimulator). Its "standalone performance" refers to its electrical output, safety, and functionality as evaluated in non-clinical bench tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device and submission, the "ground truth" is primarily established by compliance with recognized electrical and medical device safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, IEC 62366, ANSI/AAMI NS4:2013/(R)2017) and the established safety and effectiveness of the legally marketed predicate devices for their intended uses. The document states that "The Avazzia device technological specifications are similar; therefore, they do not pose new questions regarding safety and effectiveness." The usability study also confirmed that the device and instructions "met requirements for usability factors for over-the-counter use."
8. The sample size for the training set
This information is not applicable as the device is a hardware TENS stimulator and does not involve AI/machine learning models with training sets.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
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