(135 days)
The WELL-LIFE OTC Abdomen System / Model WL-2412 is the electrical muscle stimulator intended for the following indication for use:
• Strengthening, toning and firming of the abdomen region.
The Well-Life OTC ABDOMEN SYSTEM model WL-2412 is battery-operated programmable muscle stimulator intended to improve or facilitate muscle performance by applying an electrical current to electrodes, which are attached on abdomen.
Well-Life OTC ABDOMEN SYSTEM model WL-2412, consists mainly of three parts: the stimulator , electrodes, and support belts fitting for special parts of body. The stimulator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the specified region, so as to transmit this stimulus current to the region of abdomen for the following intended purposes:
- Strengthening, toning and firming of the abdomen region.
To adequately locate the stimulation on the intended treatment area, the following support belt is provided together with the stimulator:
- · The abdomen belt, which is capable of connecting to the both two output channels of stimulator.
The stimulation mode for Well- Life OTC ABDOMEN SYSTEM includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.
Here's a breakdown of the acceptance criteria and study information for the Well-Life OTC Abdomen System (model WL-2412) based on the provided 510(k) summary:
This device is a Powered Muscle Stimulator, which typically focuses on electrical and functional safety, and comparisons to predicate devices for substantial equivalence. It does not involve AI or complex diagnostic accuracy studies.
Device Acceptance Criteria and Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Safety | Compliance to voluntary standards | ANSI/AAMI NS4-1985 (likely for electrical safety and performance of powered muscle stimulators) |
| Compliance to voluntary standards | EN 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | |
| Compliance to voluntary standards | EN 60601-1-1 (Collateral standard for safety requirements for medical electrical systems - likely specific to the combination of the stimulator and accessories) | |
| Compliance to voluntary standards | EN 60601-1-2 (Collateral standard for electromagnetic compatibility - requirements and tests) | |
| Software verification | Carried out according to FDA software guidance | |
| Effectiveness | Maintenance of intended use | The differences in the submitted model do not "affect the intended use," which is "Strengthening, toning and firming of the abdomen region." |
| Maintenance of fundamental scientific technology | The differences in the submitted model do not "alter the fundamental scientific technology of the device," implying it operates on the same principle as the predicate device. | |
| Verification & Validation Tests (Overall Equivalence) | "Verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted model could maintain the same safety and effectiveness as that of cleared device." (Details of these tests beyond standard compliance are not provided in the summary). | |
| Functional Equivalence | Comparison to Predicate Device (Slendertone Flex K010335) | The device "has the same intended use and technological characteristics as the cleared device," and engineering differences do not affect intended use or fundamental scientific technology. |
Study Information
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The 510(k) summary does not mention a specific "test set" in the context of clinical data or patient outcomes for this type of device. The evaluation appears to be based on:
* Engineering and Performance Testing: Compliance with recognized electrical and safety standards (ANSI/AAMI, EN 60601 series). These tests likely involve laboratory settings and instrumentation, not human subjects or patient data.
* Software Verification: Done according to FDA guidance.
* Comparison to Predicate Device: Evaluation of technological characteristics.
No information regarding country of origin, retrospective/prospective nature, or sample size for patient data is provided because such studies were not deemed necessary for this type of device and submission.
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 in a clinical or diagnostic context for this type of device or submission. The evaluation relies on engineering standards, software validation, and a comparison of technical specifications to a predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication process of the type described was utilized.
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 powered muscle stimulator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a muscle stimulator, not an algorithm, and its intended use does not involve human-in-the-loop performance in a diagnostic or AI context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's safety and effectiveness is largely based on adherence to recognized electrical and medical device safety standards (ANSI/AAMI, EN 60601 series) and demonstrated functional equivalence to a legally marketed predicate device (K010335). There isn't a complex clinical "ground truth" in the diagnostic sense.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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).