(91 days)
The Zionic Aesthetic is intended to provide topical heating tor the purpose of elevating tissue temperature for treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.
The ZIONIC ASTHETIC is a resistive radiofrequency device which output energy can reach up to 200W. It has two different electrodes with different sizes, to adapt the treatment to the different body areas. The electrodes roll to perform a massage while applying the radiofrequency energy.
This document is an FDA 510(k) summary for the ZIONIC AESTHETIC device. It asserts substantial equivalence to a predicate device, the Nuera Tight RF. The information provided heavily focuses on the technical specifications and safety testing, not on efficacy or clinical performance data typically associated with acceptance criteria and studies demonstrating device performance against those criteria, especially for claims like "temporary reduction in the appearance of cellulite" or "temporary relief of pain."
Therefore, based solely on the provided text, it is not possible to fully answer many of the requested points, particularly those related to clinical performance, a multi-reader multi-case study, or detailed ground truth establishment for a test set demonstrating efficacy. The document explicitly states "Clinical Evidence – N/A. No clinical studies were conducted as part of this submission."
However, I can extract the information that is present regarding the technical performance and the comparative testing against the predicate device.
Here's an attempt to answer based on the provided text, highlighting what is present and what is explicitly stated as not applicable or missing:
Acceptance Criteria and Reported Device Performance
The acceptance criteria described in this document are primarily related to technical performance, electrical safety, and software validation, rather than direct clinical efficacy for the stated indications. The "performance testing" section outlines these.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1:2005 + Corr.1:2006 + A1:2012 (General Requirements For Basic Safety And Essential Performance) | "Verification and validation activities were successfully completed and establish that the ZIONIC AESTHETIC control unit performs as intended." (Implicitly means compliance was demonstrated) |
| Compliance with IEC 60601-1-2:2014 + A1:2020 (Electromagnetic Disturbances) | "Verification and validation activities were successfully completed and establish that the ZIONIC AESTHETIC control unit performs as intended." | |
| Compliance with IEC 60601-2-2:2017 (Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment) | "Verification and validation activities were successfully completed and establish that the ZIONIC AESTHETIC control unit performs as intended." | |
| Software Validation | Compliance with IEC 62304:2006+A1:2015 (Medical Device Software Life Cycle Processes) | "Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices." |
| Risk Management | Compliance with EN ISO 14971:2019+A11:2021 (Application Of Risk Management To Medical Devices) | "Verification and validation activities were successfully completed and establish that the ZIONIC AESTHETIC control unit performs as intended." |
| Temperature Control | Device can maintain a temperature of 40°C for 10 minutes of treatment for every electrode used. | "Tests for the Zionic Aesthetic included two patients and three test sites – abdomen, thighs, and arms—and a temperature of 40° C (+2 °C) was maintained for 10 minutes of treatment." |
| Output Accuracy | Accuracy of output power, output frequency, and output voltage. | "Performance testing was performed to demonstrate the accuracy of the output power, output frequency, and output voltage." (Implicitly, this testing confirmed accuracy, though specific +/- deviations are not provided in this summary.) In comparison to the predicate, ZIONIC AESTHETIC maximum power is 200W vs predicate's 250W, noted as "nearly identical" and "makes the device safer." Frequency is 470kHz, identical to one of the predicate's frequencies. Voltage is 115VAC/230VAC, same as predicate's 100-240VAC range. |
Detailed Study Information (Based on the provided text):
1. A table of acceptance criteria and the reported device performance:
See table above.
2. Sample size used for the test set and the data provenance:
* Clinical "Test" for Temperature Maintenance: "two patients and three test sites – abdomen, thighs, and arms—". This is a very small sample focused on a biophysical parameter (temperature maintenance), not clinical efficacy.
* Provenance: Not explicitly stated, but the applicant's address is Gijón, Spain, so it's possible this limited testing was conducted there. It is retrospective in the context of this 510(k) submission, as it was performed prior to the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable / Not stated. For the temperature maintenance test, "ground truth" would be the direct temperature measurements. For clinical indications like cellulite reduction or pain relief, no clinical studies were performed, and thus no expert-derived ground truth for efficacy was established for the ZIONIC AESTHETIC. The premise of the 510(k) is substantial equivalence to a predicate, not independent clinical proof of efficacy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable. Given the nature of the "performance testing" (technical and temperature measurements), there's no mention or need for an adjudication method as would be used in a clinical efficacy study involving subjective assessments.
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:
* No, not applicable. The device is a physical aesthetic/therapeutic device, not an AI or imaging diagnostic tool that would typically involve human readers or MRMC studies. The document explicitly states: "Clinical Evidence – N/A. No clinical studies were conducted as part of this submission."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. This isn't an algorithm that would have "standalone" performance in the sense of an AI diagnostic. The device functions independently in applying RF energy and massage. Its performance is measured by its output characteristics and ability to maintain temperature.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* For the technical performance tests (electrical safety, software, output accuracy), the ground truth is based on engineering specifications and adherence to international standards (e.g., IEC standards).
* For the temperature maintenance test, the ground truth was direct temperature measurements from the skin (on 2 patients).
* For the clinical indications (pain relief, cellulite reduction), the document explicitly states "No clinical studies were conducted as part of this submission." Therefore, no ground truth related to clinical outcomes was established for the ZIONIC AESTHETIC in this submission. The claim for these indications relies on substantial equivalence to the predicate device which presumably had a basis for these claims.
8. The sample size for the training set:
* Not applicable. This device is not an AI/machine learning model where a "training set" would be relevant.
9. How the ground truth for the training set was established:
* Not applicable. See point 8.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.