(116 days)
The GEMORE GEM-TONE Abdominal Training System/model GEM-TONE 310PE/320PE/340PE/340PE/350PE are the electrical muscle stimulator intended for the following indication for use:
- Strengthening, toning and firming of the abdomen region.
The GEMORE GEM-TONE Abdominal Training System and its stimulation programs are not designed for injured or ailing muscles, and use on such muscles is contraindication.
The GEM-TONE Abdominal Training System model GEM-TONE 310PE/ 320PE /330PE /340PE / 350PE is battery-operated programmable muscle stimulator intended to improve or facilitate muscle performance by applying an electrical current to electrodes, which is attached on abdomen region.
GEM-TONE Abdominal Training System model GEM-TONE 310PE / 320PE /330PE /340PE /350PE, 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.
The GEMORE GEM-TONE Abdominal Training System and its stimulation programs are not designed for injured or ailing muscles, and use on such muscles is contraindication.
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 GEM-TONE Abdominal Training 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.
This submission describes a premarket notification (510(k)) for the GEM-TONE Abdominal Training System, a powered muscle stimulator. The purpose of the 510(k) is to demonstrate substantial equivalence to a predicate device, the Slendertone Flex (K010335).
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy, as would be typical for diagnostic or AI-driven devices. Instead, the "acceptance criteria" for this muscle stimulator appear to be centered around compliance with recognized electrical safety and regulatory standards, and demonstrating equivalent functionality to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance/Evidence |
|---|---|
| Electrical Safety and Performance Standards | Compliance to applicable voluntary standards including ANSI/AAMI. NS4-1985 (likely AAMI/ANSI NS4-1985 for transcutaneous electrical nerve stimulators, though not explicitly stated for this exact device type, it's a common standard for similar devices), EN 60601-1 (medical electrical equipment - general requirements for basic safety and essential performance), EN 60601-1-1 (collateral standard for safety requirements for medical electrical systems), and EN 60601-1-2 (collateral standard for electromagnetic compatibility). |
| Software Verification | Software verification has been carried out according to FDA software guidance. |
| Substantial Equivalence to Predicate Device (K010335) | The device "has the same intended use and technological characteristics as the cleared device of Slendertone Flex (K010335)." "Verification 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." This implies functional equivalence in muscle stimulation. |
| Intended Use | "Strengthening, toning and firming of the abdomen region." This is identical to the implied intended use of the predicate device. |
2. Sample Size for the Test Set and Data Provenance
The provided document does not specify any clinical studies or test sets with human participants that would typically involve a "sample size" for performance evaluation in the way an AI/diagnostic device would. The "verification tests" mentioned are likely technical and engineering tests to ensure compliance with electrical and software standards, rather than a clinical trial.
Therefore, information on:
- Sample size used for the test set: Not applicable/not provided for clinical performance testing.
- Data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as no clinical data studies are described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the submission focuses on demonstrating electrical safety, software compliance, and functional equivalence to a predicate device through non-clinical testing. There is no mention of a ground truth established by experts for a test set in the context of this 510(k) summary.
4. Adjudication Method for the Test Set
This information is not applicable as there is no described test set of clinical data with expert ground truth to be adjudicated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed, nor any effect size for human readers improving with or without AI assistance. This type of study is typically relevant for interpretative diagnostic devices, not for a muscle stimulator.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
This concept is not applicable to the GEM-TONE Abdominal Training System described. This device is a powered muscle stimulator, and its functionality does not involve an "algorithm only" performance or human-in-the-loop interpretation in the way a diagnostic AI would. Its performance is directly tied to its electrical output and user interaction (attaching electrodes).
7. Type of Ground Truth Used
There is no mention of a specific "ground truth" (e.g., expert consensus, pathology, outcomes data) being established for clinical performance as no such clinical study is described. The "ground truth" for this submission refers to the established safety and effectiveness standards of the predicate device and the relevant electrical safety standards. The device's performance is measured against these technical and regulatory benchmarks.
8. Sample Size for the Training Set
This information is not applicable. The device is a muscle stimulator, not an AI/machine learning model that requires a "training set" of data. The software verification mentioned refers to adherence to good software engineering practices and FDA guidance, not to training an AI model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI model.
§ 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).