(88 days)
The model GM310PP, GM320PP, GM321PP, and GM321PP are intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
The Gemore Low Back Pain Relief System, models GM310PP, GM320PP, GM321PP, and GM330PP are non-invasive devices which are intended for over the counter use in temporary relief of pain associated with sore and aching muscles in the lower back due to stain from exercise or normal household and work activities.
The devices contain the following main parts: TENS stimulation unit, Support Belt, Self-adhesive pads, and Snap Cable.
The device can be worn on the low back part of user so as to place the stimulation pads on the treatment location of low back.
The main stimulation function is achieved through the stimulation unit of GM310PP, GM320PP, GM321PP, and GM330PP. Those stimulation units have been cleared for 510(k) before being submitted on this new submission for OTC application. The K-number for these four models are K032720.
The provided 510(k) summary for the "Low Back Pain Relief System, model GM310PP, GM320PP, GM321PP, and GM330PP" indicates that its acceptance criteria and clinical performance were established through a substantial equivalence pathway, rather than a de novo study with specific performance targets. This means the device's safety and effectiveness are demonstrated by showing it is as safe and effective as a legally marketed predicate device.
Here's an analysis based on the provided text, addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Technological Equivalence to Predicate Device: The device must demonstrate similar technological characteristics to its predicate device, with differences being insignificant and not affecting safety or effectiveness. | "A comparison of the technological characteristics of the Gemore models GM310PP, GM320PP, GM321PP, and GM330PP and the predicate device has been performed. The results of this demonstrate that the Gemore model GM310PP, GM320PP, GM321PP, and GM330PP are equivalent to the marketed predicate device. The differences... are insignificant and do not affect the safety or effectiveness of the device." |
| Intended Use Equivalence: The device must share the same intended use as its predicate. | The intended use statement for GM310PP, GM321PP, and GM330PP ("temporary relief of pain associated with sore and aching muscles in the low back due to strain from exercise or normal household and work activities") aligns with the predicate device, K040512. |
| Safety Testing (Electrical Safety): Compliance with relevant safety standards for Transcutaneous Electrical Nerve Stimulators (TENS) units. | "The performance testing reports according to ANSI/AAMI NS4, and the safety testing reports according to EN 60601-1, EN 60601-1-1, and EN 60601-1-2 as mentioned in the previous 510(k) submission documents are still available for this submission." (Referring to K032720 for the core stimulation units). |
| Biocompatibility Testing (for additional components): Compliance with relevant biocompatibility standards for components that come into contact with the skin. | "For the additional fixing part, the neoprene belt, the bio-compatibility testing report done according to ISO 10993-1 as well as the relevant standards are included in this submission." |
| Overall Substantial Equivalence: The device must be deemed substantially equivalent to a legally marketed predicate device. | "Gemore Technology Inc, has demonstrated through its evaluation of the Gemore models GM310PP, GM320PP, GM321PP, and GM330PP that the devices are equivalent to the predicate devices with respect to intended use, technological characteristics, and safety and effectiveness." This conclusion was affirmed by the FDA's 510(k) clearance letter (K060222). |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not refer to a "test set" in the context of clinical performance data generated specifically for this device (GM310PP, GM320PP, GM321PP, GM330PP).
Instead, the submission relies on:
- Previous 510(k) submissions (K032720) for the core TENS stimulation units (GM310PP, GM320PP, GM321PP, GM330PP) for their performance and safety testing. The specific details of any clinical "test set" from K032720 are not provided in this document.
- Bench testing and materials characterization for the new components (e.g., neoprene belt). These are not clinical studies with human subjects for efficacy.
Therefore, information regarding country of origin of data or retrospective/prospective nature is not applicable for a direct clinical test set for this specific 510(k) submission. It's an affirmation of equivalence based on existing data and bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This substantial equivalence submission does not describe a clinical study that required expert consensus for ground truth on human subjects. The "ground truth" here is compliance with established engineering and biocompatibility standards, and the predicate's known safety and performance.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication of results from multiple readers/observers is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not done for this device. The submission relies on demonstrating equivalence to an already marketed device, not on showing human reader improvement with or without AI assistance. This device is a Transcutaneous Electrical Nerve Stimulator, not an AI-powered diagnostic system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical device (TENS unit) for pain relief, not an algorithm, and thus standalone algorithm performance is not relevant.
7. Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Compliance with recognized voluntary consensus standards: ANSI/AAMI NS4 (performance for TENS), EN 60601-1 series (electrical safety), and ISO 10993-1 (biocompatibility).
- Demonstrated safety and effectiveness of the predicate device (K040512). The predicate device serves as the benchmark against which substantial equivalence is claimed.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established in that context.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).