(111 days)
The Slendertone Flex device is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the purpose of improving abdominal muscle tone.
The device is indicated for the improvement of abdominal muscle tone, for strengthening of the abdominal muscles and for developing a firmer abdomen.
The Slendertone Flex Abdominal Training system is a two- channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It comprises two main components, namely, an electronic stimulator module which generates the required stimulation signals, and an abdominal electrode belt, which connects the signals from the stimulator to the skin electrodes located on the inner surface of the belt. In effect, the belt in this case takes the place of the lead-wires in most conventional muscle stimulators.
The product is supplied with a set of double- sided adhesive electrodes, an instruction manual, a set of batteries, and a carry pouch. Power is derived from three AAA cells located in a compartment protected by a removable battery cover.
Although a two- channel system, there are only three electrodes, since the central umbilical electrode is common to the each of the left and right stimulation circuits. The electrodes connect adhesively to studs on the inner surface of the belt. The user extends the belt and puts it on in a wrapping motion from front to back, closing it at the back using the hook and loop patches. When the belt is in place on the body the larger center electrode locates over the umbilicus and the two side electrodes locate on either side of the body towards the mid axillary line, between the pelvis and the ribcage. It has been found that this electrode positioning is particularly useful for stimulating the abdominal muscles.
The pulsed stimulation current passes between the side and center electrodes only. There is no current passed from side to side. Because the user has no access to the wiring or connectors within the belt, he/she cannot alter the current path and so the possibilities for mis-use are greatly reduced
The provided text describes a 510(k) summary for the Slendertone FLEX Abdominal Training System, Type 515. This submission focuses on demonstrating substantial equivalence to a predicate device, not on validating novel performance claims through clinical studies against specific acceptance criteria. Therefore, much of the requested information (like acceptance criteria, sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth for training) is not present in this document.
Here's a breakdown of what can be extracted and what is not available from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The submission focuses on substantial equivalence to a predicate device and compliance with safety standards rather than specific performance metrics (e.g., a certain percentage improvement in muscle tone) as acceptance criteria. | The "Non clinical Tests" section states: "Comparisons of electrical outputs for the two devices show similar results." This indicates that the new device's electrical output is comparable to the predicate device. |
| Compliance with specific safety and EMC standards. | The device has been designed and independently tested to the following requirements: |
- IEC 60601-1:1990 Medical electrical equipment Part 1: General requirements for safety.
- IEC 60601-2-10
- IEC 601-1-1 and appendices A1:1991,A2:1995
- IEC 601-1-2: EMC requirements
- IEC 61000-4-2:1995: Electromagnetic compatibility.
- IEC 61000-4-3:1997: Electromagnetic compatibility
- DD ENV 50204:1996: Electromagnetic compatibility
- EN 55011:1998: radiated emissions. |
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 mentioned. The document describes non-clinical tests (electrical output comparisons and compliance with standards) and hazard/risk analyses, but not human subject testing with a defined test set.
- Data Provenance: Not mentioned for any test data.
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)
- Number of Experts: Not applicable/not mentioned. No ground truth was established by experts in the context of a test set for performance claims.
- Qualifications of Experts: Not applicable/not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not mentioned. No human subject test set or adjudication process is described.
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
- MRMC Study: No. This device is a muscle stimulator, not an AI-powered diagnostic tool, so an MRMC study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithm-only device. The submission focuses on the safety and electrical performance of the physical muscle stimulator and its equivalence to a predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable. For the non-clinical tests described, the "ground truth" would be the specified parameters in the electrical output tests and the requirements of the international safety and EMC standards. There is no biological or clinical "ground truth" established for performance claims from human subjects in this document.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/not mentioned. This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As there is no training set, there is no ground truth established for one.
§ 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).