(217 days)
The Everyway Low Back Pain Relief System, model EV-820 is indicated for over the counter use in the 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.
The Everyway Low Back Pain Relief System, models EV-820 is a 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 which was designed to generate 8 preprogram modes of output stimulation pulse, Support Belt, Self-adhesive pads, and Snap Cable. With the combination of the main device parts, 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 for over the counter use without prescription in temporary relief of pain associated with sore and aching muscles in the lower back.
Here's an analysis of the provided 510(k) summary regarding acceptance criteria and study information:
This device is a TENS unit, a type of electrotherapy device. The submission explicitly states "No particular Clinical Test was conducted for Everyway Low Back Pain Relief System, model EV-820." Therefore, there is NO clinical study information, acceptance criteria, or performance data related to clinical effectiveness presented in this document for the EV-820 device.
The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device (Gemore Low Back Pain Relief System, model GM310PP (K060222)) through non-clinical testing.
Here's the breakdown based on your requested information, highlighting the lack of clinical study data:
1. Table of acceptance criteria and the reported device performance:
Since no clinical study was conducted for the Everyway Low Back Pain Relief System, model EV-820, there are no acceptance criteria or reported device performance related to pain relief efficacy from such a study in this document.
The non-clinical tests performed were primarily for safety and engineering compliance. The acceptance criteria for these tests would typically be compliance with the respective standards, but the specific numerical criteria and detailed results are not provided in this summary.
| Test Type (Non-Clinical) | Acceptance Criteria (Implied) | Reported Performance (Result) |
|---|---|---|
| Performance Compliance Test (ANSI/AAMI NS4) | Compliance with ANSI/AAMI NS4 standards for Transcutaneous Electrical Nerve Stimulators | Conducted by manufacturer (Implied compliance) |
| Usability Study (IEC 60601-1-6) | Compliance with IEC 60601-1-6 for usability engineering | Conducted by manufacturer (Implied compliance) |
| Electrical Compliance Test (IEC 60601-1) | Compliance with IEC 60601-1 general requirements for basic safety and essential performance | Conducted by accredited laboratory (Implied compliance) |
| EMC Compliance Test (IEC 60601-1-2) | Compliance with IEC 60601-1-2 for electromagnetic compatibility | Conducted by accredited laboratory (Implied compliance) |
| Biocompatibility Test (ISO 10993-5 & ISO 10993-10) | Compliance with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization) for support belt and stimulation electrode | Conducted by accredited laboratory (Implied compliance) |
2. Sample size used for the test set and the data provenance:
- Clinical Efficacy Test Set: Not applicable, as no clinical efficacy study was conducted.
- Non-Clinical Test Sets: The sample sizes for the non-clinical tests (e.g., number of devices tested for electrical compliance, number of participants for usability study, specific amounts of materials for biocompatibility) are not detailed in this summary. The data provenance would be the respective testing laboratories or the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical efficacy study with expert-established ground truth was conducted. For non-clinical tests, "ground truth" is typically defined by compliance with the technical standards, which are established by expert consensus in standards bodies.
4. Adjudication method for the test set:
- Not applicable, as no clinical efficacy study requiring adjudication for ground truth was conducted.
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 TENS unit for pain relief, not an AI-assisted diagnostic or interpretive system. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a TENS unit, not an algorithm or AI system.
7. The type of ground truth used:
- Clinical Efficacy: Not applicable, as no clinical efficacy study was conducted.
- Non-Clinical: The "ground truth" for the non-clinical tests is regulatory compliance with established international and national standards (e.g., ANSI/AAMI NS4, IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10).
8. The sample size for the training set:
- Not applicable, as this device does not involve machine learning or AI, and therefore has no "training set."
9. How the ground truth for the training set was established:
- Not applicable, as this device does not involve machine learning or AI, and therefore has no "training set" or ground truth for one.
In summary, the 510(k) submission for the Everyway Low Back Pain Relief System, model EV-820, relies entirely on demonstrating substantial equivalence to a predicate device through non-clinical performance and safety testing. It explicitly states that no clinical tests were conducted for the device's effectiveness. Therefore, all questions related to clinical study design, endpoints, acceptance criteria for efficacy, and ground truth establishment for clinical performance are not applicable to the information provided in this document.
§ 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).