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510(k) Data Aggregation
(325 days)
GEMORE MUSCLE CONDITIONER;
The Gemore Muscle Conditioner, model GM310PE/GM320PE/GM330PE/GM340PE/ GM350PE are intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
The Gemore Muscle Conditioner, model GM310PE/GM320PE/GM330PE/GM340PE/ GM350PE are not intended to be used in conjuction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Gemore Muscle Conditioned training programs are designed for injured or ailing muscle and it's use on such muscle in contraindicated.
The Gemore Muscle Conditioner, model GM310PE/GM320PE/GM330PE/GM340PE/ GM350PE electrically impulse triggering actions potentials on motoneurones of motor nerves(excitations). The excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber response that correspond to muscle work. Depending on the parameters of the electrical impulses(pulse frequency, duration of contraction, duration of rest, total session duration), different type of muscle work can be imposed on the stimulated muscles.
The various types of muscle work that Gemore Muscle Conditioner can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Gemore Muscle Conditioner, model GM310PE/GM320PE/GM330PE/GM340PE/ GM350PE may therefore be considered a technique of muscle training.
The Gemore Muscle Conditioner, model GM310PE/GM330PE/GM340PE/GM340PE/GM350PE are the battery-operated programmable muscle stimulator intended to improve or facilitate muscle performance by applying an electrical current to electrodes, which is attached on the healthy muscle.
Gemore Muscle Conditioner, model GM310PE/GM330PE/GM330PE/GM40PE/GM350PE, consists mainly of three parts: the stimulator , special butterfly type self-adhesive electrode (GelPads), and leader wire fitting for the stimulation of any healthy muscle 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 healthy muscle the following intended purposes:
- to stimulate healthy muscles in order to improve or facilitate muscle performance.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Device: Gemore Muscle Conditioner (models GM310PE/ GM320PE/GM330PE/GM340PE/GM350PE)
Intended Use: To stimulate healthy muscles in order to improve or facilitate muscle performance. Not intended for therapy or treatment of medical diseases or conditions, or for use on injured or ailing muscles.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the Gemore Muscle Conditioner is a Powered Muscle Stimulator, and its clearance is based on substantial equivalence to predicate devices. This means its "acceptance criteria" are primarily met by demonstrating that it performs comparably and safely to already legally marketed devices with a similar intended use and technological characteristics. The document does not explicitly list specific quantitative acceptance criteria (e.g., "device must achieve X% accuracy" or "output current must be within Y range") as might be seen for diagnostic AI/ML devices.
Instead, the "performance" proof is qualitative, asserting equivalence to predicate devices.
| Acceptance Criteria Category (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence | The Gemore Muscle Conditioner models have the same intended use as the cleared predicate device Slendertone EnerVive™ Type 561 (K071666). |
| Technological Characteristics Equivalence | The Gemore Muscle Conditioner models have the same technological characteristics as the cleared predicate device GEM-TONE Abdominal Training System, model GEM-TONE 310PE / 320PE /330PE /340PE /350PE (K091833). |
| Safety and Effectiveness Equivalence | Verification and validation tests demonstrate that differences in the submitted model "do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device," thus maintaining "the same safety and effectiveness as that of cleared device." |
| Voluntary Standards Compliance | Complies with ANSI/AAMI, NS4-1985, EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirements. |
| Software Verification | Carried out according to FDA software guidance. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain information about a specific "test set" in the way one would describe data used for evaluating an AI/ML or diagnostic device. The evaluation appears to be based on engineering and design verification/validation against standards and predicate devices, rather than a clinical study with a defined patient population or dataset. Therefore, there is no mention of sample size or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable or not provided in the document. The device is a powered muscle stimulator, not a diagnostic device requiring expert interpretation of results for ground truth. Its evaluation is against engineering standards and the performance of predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable or not provided. There is no "test set" and thus no adjudication method 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
An MRMC study was not done. This device is a muscle stimulator, not an AI/ML diagnostic tool that would assist human readers in interpreting cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable or not provided. The device is a physical muscle stimulator, not an algorithm, so the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic studies (e.g., pathology, outcomes data) is not directly relevant to the described evaluation. Instead, the "ground truth" for this device's performance demonstration lies in:
- Compliance with recognized voluntary electrical and medical device safety/performance standards (e.g., ANSI/AAMI, EN 60601 series).
- Demonstrating that its technological characteristics and intended use align with legally marketed predicate devices that have prior FDA clearance.
- Internal verification and validation tests (details not provided beyond their mention in the conclusion).
8. The Sample Size for the Training Set
This information is not applicable or not provided. This device is not an AI/ML system that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable or not provided, as there is no "training set" for this type of device.
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