(56 days)
The Gemore OTC TENS, Model GM310PP/GM321PP/GM330PP, is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities
The Gemore OTC TENS. model GM310PP/GM321PP/GM321PP/GM330PP is a dual channel transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the user's skin. The output and waveform characteristic is fixed for every operation mode, only the intensity is adjustable within specified limit.
The Gemore OTC TENS, model GM310PP/GM320PP/GM321PP/GM330PP, consist mainly of two parts: the stimulus generator, electrode. The stimulus generates the output current specified as the innut of controller. The output port transmits the output current to the electrode, which is attached to the user's skin so as to transmit this stimulus current for pain relief.
The stimulation modes for Gemore OTC TENS is pre-program modes width, pulse rate, frequency. The timer and amplitude for each program are adjustable. This operation way is considered the simplification from the pre-program modes of comparison clear model, OTC TENS For Low Back Pain Relief/ Model GM310PP/GM320PP /GM321PP/ GM330PP (K060222). Every operation mode of Gemore OTC TENS, model GM310PP/GM320PP/ GM321PP/GM330PP has its individual stimulation operation cycle.
My apologies, but the provided text from the FDA 510(k) K150681 document does not contain information about acceptance criteria for a study proving device performance, nor details of such a study for the Gemore OTC TENS.
The document is a 510(k) summary, which is essentially a submission to the FDA demonstrating that a new medical device is "substantially equivalent" to a legally marketed predicate device. This process primarily relies on comparing the new device's intended use and technological characteristics to those of predicate devices, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria in the same way a PMA (Premarket Approval) might.
Here's a breakdown of what is and is not in the document, relative to your request:
What the document does include relevant to device performance, but not in the format of "acceptance criteria study":
- Non-Clinical Tests Performed (Section 6): It mentions compliance with voluntary standards like IEC 60601-1, IEC 60601-1-2, ISO 10993-5, and ISO 10993-10, as well as software verification according to FDA guidance. These are safety and performance standards that the device is stated to meet, but they are not presented as "acceptance criteria" against which a specific study's results are presented.
- Comparison of Significant Device Features (Section 7) and Output Characteristics (Section 8): These sections compare the new device's specifications (e.g., max phase charge, max current density, waveform, voltage, current) to those of the predicate devices. The implicit "acceptance criteria" here is that the new device's characteristics are "very close and within the acceptable range as specified in FDA guidance" (Section 10) and do not "affect the intended use or alter the fundamental scientific technology" (Section 11) compared to the predicate.
- Conclusions (Section 11): States that "verification and validation tests contained in this submission demonstrate that the submitted models could maintain the same safety and effectiveness as that of cleared device." However, the details of these "verification and validation tests" are not provided in this summary document.
What the document does not include from your request:
- A table of explicit acceptance criteria and corresponding reported device performance from a specific study.
- Sample sizes used for a test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth, nor their qualifications.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, or effect sizes for human readers with/without AI assistance.
- Standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
In summary:
This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on similar design, intended use, and conformance to recognized safety and performance standards for TENS devices. It does not document a specific study with acceptance criteria to prove the device's performance in the way your request outlines, which is typically seen for higher-risk devices or novel technologies requiring clinical efficacy studies. The "performance" assessment here is primarily a comparison to established devices and compliance with general device standards.
§ 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).