(550 days)
Rugalift is indicated for cosmetic use.
Rugalift works by delivering electrical microcurrents to stimulate the skin of the face in a non invasive way. The body of the device includes the electronics for the control of the device, and the power switch for the activation of the device by the user and a detachable applicator with 5 microelectrodes. Rugalift is switched on when the microelectrodes are on the skin and pressing the finger on the power switch. The output of the device increases linearly over the first 10 seconds of stimulation, then it remains constant for 13 seconds and stops. The output cannot be changed by the user. During the treatment, an acoustic signal is activated. The frequency of the acoustic signal increases as the output current increases. When the user removes the device from the face, it automatically resets and turns itself off. Rugalift is powered by a 12V power adapter which is supplied with the device.
The provided text describes a 510(k) premarket notification for a device called "Rugalift". It details its intended use, technological characteristics, and performance data, alongside its substantial equivalence claim to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Instead, it asserts conformity with several international standards related to safety and electrical equipment. The "Performance Data" section lists these standards as the basis for compliance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety Standards & Electrical Compatibility: | |
| Conformity to EN 60601-1-2 ED. 2 (2001) | Stated that Rugalift is in conformity. |
| Conformity to IEC 60601-1-2 (2001-09) | Stated that Rugalift is in conformity. |
| Conformity to EN 60601-2-10 (2001-11) | Stated that Rugalift is in conformity. |
| Conformity to EN 60601-2-10 (1990-08) and its amendments | Stated that Rugalift is in conformity. |
| Conformity to CEI 62-39 (1992-10) | Stated that Rugalift is in conformity. |
| Usability & Safety after Self-Training: | |
| Sufficiency of documentation for self-selection and safety of the device | "The study provided evidence that the documentation included is sufficient for self-selection and safety of the device." |
| Ease of use, reliability, and safety | "Rugalift is a device that can be used easily, is reliable and safe." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions only "An usability study has been performed". It does not specify the sample size for this usability study. The provenance of the data (e.g., country of origin, retrospective or prospective nature) is also not specified in the provided text.
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)
The document does not mention the use of experts to establish ground truth for any test set. The usability study appears to be focused on user experience and safety after self-training, rather than requiring expert adjudication of clinical outcomes in the traditional sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Given that no experts are mentioned for establishing ground truth, there is no adjudication method described for a test set. The usability study is described in terms of its ability to "provide evidence that the documentation included is sufficient for self-selection and safety of the device," suggesting a direct assessment of the documentation's clarity and completeness by potentially end-users.
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
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The device, a Transcutaneous Electrical Nerve Stimulator, is not an AI-assisted diagnostic tool, so such a study would not be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The Rugalift is a physical medical device, not an algorithm. Its performance is inherent in its electrical stimulation capabilities and its interaction with a user.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the usability study, the "ground truth" implicitly relates to the sufficiency of documentation for self-selection and safety, and the device being easy to use, reliable, and safe. This would likely be established through direct observation, user feedback, and potentially expert review of the documentation itself and the device's operational specifications against safety standards, rather than clinical outcomes data or pathology reports.
8. The sample size for the training set
The document does not mention a training set in the context of device development or evaluation. The usability study is the only study described, and it is not identified as a "training set."
9. How the ground truth for the training set was established
As no training set is mentioned, this question is not applicable.
§ 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).