(209 days)
The EM25 - glute toning device is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the purpose of improvement of muscle tone of the buttocks muscles.
The proposed device, EM25 - glute toning device is a self-adhesive EMS device for muscle training. The device can be applied with accuracy thanks to the use of EMS technology. Made from medical-quality silicone rubber, the elegantly designed EMS pad is extremely slim and flexible and adapts perfectly to the area to be treated. The high-tech circuit provides energy-efficient treatments of 20 minutes each.
Electrical muscle stimulation (EMS) is a widespread and generally recognized method and has been used in sports medicine and rehabilitation for years. In sports and fitness, EMS is used to complement conventional muscle training, to increase the performance of muscle groups and to adjust physical proportions to achieve the desired aesthetic results.
EMS devices work by passing electrical currents over the skin. The gel pad is used as a transfer medium and is subject to natural wear and tear. The gel pad must be replaced if it stops providing sufficient contact, as this will prevent the EMS pad from sticking to the skin. If it is not replaced, the partially increased current density could irritate the skin.
The proposed device, EM25 - glute toning device is assembled with the PCBA and electrode, and the LR03 (AAA) battery supplies the safe low-frequency current. The electrode stuck on the human skin purposes to train the deep muscle. There are 0-15 intensity levels for EM25 - glute toning device. The maximum voltage is divided by 15 (levels) and accumulated for each voltage. But the each increased amperage cannot be over 2%. The intensity level will be minimum when turning on. The user can adjust it from 0 to 15 and gradually increase the intensity level. The whole treatment time is 20 minutes, and then the device switches off automatically.
The EM25 - glute toning device is a powered muscle stimulator intended to improve muscle tone of the buttocks muscles in healthy persons through transcutaneous electrical muscle stimulation (EMS).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in terms of clinical performance metrics (e.g., a specific percentage improvement in muscle tone measured by a defined metric). Instead, the acceptance criteria are implicitly defined by compliance with a series of recognized safety and performance standards. The "reported device performance" is essentially that the device met these standards, and is deemed substantially equivalent to a predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility: Compliance with ISO 10993 series | All tests demonstrate compliance with ISO 10993 series. |
| Software: Compliance with IEC 62304 and ISO 14971 | All tests demonstrate compliance with IEC 62304 and ISO 14971. |
| Electromagnetic Compatibility & Electrical Safety: Compliance with IEC 60601 series | All tests demonstrate compliance with IEC 60601 series. |
| Risk Management: Compliance with ISO 14971 | All tests demonstrate compliance with ISO 14971. |
| Functional Performance (Implicit, compared to predicate) | Device output specifications (voltage, current, frequency, etc.) are comparable to the predicate device, with some differences that were determined not to raise new safety/effectiveness issues. |
2. Sample Size Used for the Test Set and Data Provenance
No test set related to clinical performance or human efficacy is mentioned. The primary "test set" for this submission refers to the physical device itself and its components undergoing engineering and biocompatibility testing. The data provenance for these tests is implicitly from the manufacturer's testing (Hivox Biotek, Inc., Taiwan). The document confirms that no clinical test data was used to support the decision of safety and effectiveness (Section 5.9).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. No clinical test set with human data and expert ground truth was established for this submission. The "ground truth" for the non-clinical tests was adherence to the specified international standards.
4. Adjudication Method for the Test Set
Not applicable. No clinical adjudication method was used, as no clinical studies were performed.
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
Not applicable. This device is a muscle stimulator, not an AI-assisted diagnostic or imaging device, and does not involve "human readers" or AI assistance in that context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. See point 5. This device is a physical therapeutic device, not an algorithm, and does not have a "standalone" algorithmic performance in the typical sense of AI/software as a medical device.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on adherence to recognized international technical standards for safety, biocompatibility, software lifecycle, and electrical safety (e.g., ISO 10993 series, IEC 62304, IEC 60601 series, ISO 14971). The claim of "effectiveness" is supported by substantial equivalence to an existing predicate device, rather than direct clinical evidence for efficacy.
8. The Sample Size for the Training Set
Not applicable. No training set for an algorithm was used, as this is not an AI/software device that requires machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).