(227 days)
Ultra Beauty device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.
Ultra Beauty is a microcurrent device that provides facial stimulation for cosmetic purposes. Ultra Beauty provides a suite of treatment options, combining the different modes and applications from various devices available in the market. The device provides three easy to use pre-programmed modes and the device manual illustrates in detail the suggested treatment protocols for the desired results. The unit features a portable battery powered base module that features a large LCD display and various buttons for easy navigation through the different treatment settings. Ultra Beauty utilizes two different types of probes and to enhance the ease of use and the maneuverability, each probe is attached to the two separate hand pieces. Stimulations generated by the base unit are delivered to the hand pieces through conductive cables.
The provided text is a 510(k) summary for the "Ultra Beauty" device, a Transcutaneous Electrical Nerve Stimulator (TENS) for aesthetic purposes. It focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria through clinical studies.
Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes, expert qualifications, MRMC studies, standalone performance, training set details) cannot be extracted from this document because it outlines a non-clinical evaluation path.
Here's what can be gleaned from the provided text, aligning with the format requested:
1. A table of acceptance criteria and the reported device performance
This document does not include a table of acceptance criteria and reported device performance in the manner typically seen for clinical efficacy studies. Instead, the "acceptance criteria" for 510(k) clearance are based on demonstrating substantial equivalence to predicate devices. The reported "performance" is that it meets applicable safety and EMC standards and has similar technological characteristics to the predicates.
| Acceptance Criteria (for 510(k) Substantial Equivalence Review) | Reported Device Performance (as demonstrated for 510(k) clearance) |
|---|---|
| Intended Use/Indication for Use: Same as predicate devices. | "Ultra Beauty device was found to have the same intended use and indication for use as the predicate devices." (Section 4) |
| Technological Characteristics: Similar to predicate devices. | "The device also has similar technological characteristics to its predicate devices." (Section 4) |
| Safety and Effectiveness: No new questions of safety or effectiveness raised by minor differences. | "Minor differences in the technological characteristics of the Ultra Beauty device and the predicate devices do not raise any issues of safety or effectiveness." (Section 4) |
| Compliance with Voluntary Standards: Adherence to relevant electrical safety and EMC standards. | "Ultra Beauty complies with international standards for electrical safety and electromagnetic compatibility. Compliance to applicable voluntary standards includes IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, and ISO 14971: 2007." (Section 4) |
| Software Verification: Complies with FDA guidance. | "the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Section 4) |
| Risk Analysis: Comprehensive risk analysis performed. | "Comprehensive risk analysis has been carried out for the device with regards to safety and effectiveness." (Section 4) |
| Functional Safety (e.g., open/short circuit conditions): Device functions normally under specified fault conditions. | "ULTRA BEAUTY functions normally after open and short circuited conditions between output jacks, with the device operating for maximum of 15 minutes, in each condition at the maximum available setting of pulse width, pulse rate and pulse amplitude." (Section 3) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This 510(k) relies on non-clinical testing and comparison to predicate devices, not a test set of patient data.
- Data Provenance: Not applicable. The data is from non-clinical engineering and safety testing performed by Johari Digital Healthcare Ltd., located in Jodhpur, India.
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)
- Not applicable. No ground truth was established by experts from a test set of data as this was a non-clinical submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication was used.
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. An MRMC comparative effectiveness study was not performed. This device is a transcutaneous electrical nerve stimulator, not an AI-powered diagnostic aide.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm with standalone performance in the context of diagnostic or interpretive tasks.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth was established for this 510(k) submission. The ground truth for device safety and performance was based on compliance with recognized consensus standards and engineering verification.
8. The sample size for the training set
- Not applicable. No machine learning training set was used for this device.
9. How the ground truth for the training set was established
- Not applicable. No machine learning training set was used for this device.
§ 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).