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510(k) Data Aggregation
(267 days)
Slim UP® ULTRA is indicated for the use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrode for the purpose of improvement of muscle tone of buttocks muscles.
Slim UP® ULTRA is a new beauty appliance that works on the principles of Electrostimulation. Slim UP® is used in environments such as Health Spa's and Beauty Salons. Slim UP® ULTRA has following major components: Main power switch, Control panel, Infrared unit, Distribution of electro-stimulation channels. Slim UP® ULTRA electrostimulation section has 8 channels for body electrostimulation with compensated two-phase rectangular waveform, with individual intensity adjustment and 5 different multi-phase treatment programs diversified to meet the needs of the single case. Slim UP® ULTRA infrared section has 6 infrared ray sources housed in a height-adjustable, mobile arm that adapts to any couch, ensuring the ideal working distance is maintained at all times. IR source is used for patient comfort only. It does not have any therapeutic effect. Slim UP® ULTRA is a latest-generation machine occupying only half a square meter. It can be located in any booth, can be adapted to any bed and can be moved anywhere.
The acceptance criteria and study proving the device meets them are summarized below based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics. Instead, it presents a comparison between the "Slim UP® ULTRA" and its predicate device, highlighting similarities and differences, and concludes that the differences do not raise new questions of safety or efficacy. The performance data provided focuses on compliance with general safety and biocompatibility standards rather than specific therapeutic endpoints.
Implicit Acceptance Criteria (based on predicate equivalence and safety testing):
| Acceptance Criteria Category | Specific Criteria (Implicit) | Reported Device Performance and Justification |
|---|---|---|
| Functional Equivalence | Performance similar to predicate device for transcutaneous electrical muscle stimulation for improvement of buttock muscle tone. | The device operates on the basic principles of Electrostimulation, similar to the predicate. Despite differences in specific functional parameters (e.g., pulse duration, frequency, max output voltage/current, RMS current, number of programs), these differences are justified as not raising new questions of safety or efficacy due to compliance with relevant electromagnetic safety standards (IEC 60601-1, 60601-1-2, 60601-2-10). The inclusion of an IR unit is for patient comfort only, with no therapeutic effect, and is similar to a referenced device (Syneron Medical's Velashape K122579). |
| Biocompatibility | Patient-contacting parts (electrodes) must be biocompatible. | Patient-applied parts of Slim UP® ULTRA are biocompatible as per ISO 10993-1:2009. The electrodes used (FIAB PG474W, K091163) are 510(k) cleared. |
| Electrical Safety | Compliance with relevant electrical safety and electromagnetic compatibility (EMC) standards. | Compliant with IEC 60601-1:2012, IEC 60601-1-2:2007, and IEC 60601-2-10:2000. |
| Software Verification | Software/firmware operates as intended and does not pose safety risks. | Software validation was completed to check safety requirements implemented by the firmware, ensuring it operates as indicated in the user manual and causes no risks. |
| Mechanical Safety | Housing materials and construction are safe and comply with relevant standards; physical characteristics do not raise new safety concerns. | Complies with EN ISO 14121-1:2007. The difference in physical dimensions and weight, as well as housing material (polycarbonate, nylon vs. ABS/asbestos for predicate), does not introduce additional safety issues, as patient body contact parts are biocompatible and the device complies with safety standards. |
2. Sample Size for Test Set and Data Provenance
The document does not describe a clinical study with a "test set" in the context of evaluating the device's clinical performance or muscle tone improvement. The performance data provided pertains to engineering and safety testing. Therefore, there is no information on sample size or data provenance for a clinical test set.
3. Number of Experts and Qualifications for Ground Truth
The document does not describe a clinical study with a "ground truth" established by experts.
4. Adjudication Method
As no clinical study or ground truth establishment by experts is described, there is no information on an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned in the document. The device is a "Powered muscle stimulator," not an imaging or diagnostic AI device that would typically involve human readers for interpretation.
6. Standalone Performance (Algorithm Only)
The document does not describe a standalone performance study for an algorithm. The device, "Slim UP® ULTRA," is a physical medical device (powered muscle stimulator) with electrostimulation and an infrared unit, rather than a purely software-based AI diagnostic tool. Software validation was conducted to ensure the firmware operates as intended, but this is not a standalone algorithmic performance study in the typical sense for AI devices.
7. Type of Ground Truth Used
No ground truth, in the context of clinical endpoints or disease states, is described as being used for performance evaluation. The "ground truth" in the provided document relates to engineering and safety standards compliance.
8. Sample Size for the Training Set
The document does not describe an AI training set as it is not for an AI diagnostic device.
9. How Ground Truth for the Training Set Was Established
Not applicable, as no AI training set is described.
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