(273 days)
The device is intended for prescriptive use.
Indications for Use:
- Transcutaneous electrical nerve stimulation for the symptomatic relief and . management of chronic and intractable pain in the lower back region. The device has no curative values and should only be used in conjunction with medical supervision.
- . Lumbar support.
The BAXOLVE™ TENS device is a self-contained battery operated transcutaneous electrical muscle stimulator. The adhesive electrodes are mounted on a belt offering lumbar support to the user during therapy delivery.
The device is intended to provide a non-invasive prescriptive therapy.
The provided text does not contain detailed information about specific acceptance criteria related to device performance in a clinical study for the NeuroTech® BAXOLVE™, Type 294. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through technological comparison and non-clinical tests (electrical outputs and compliance with standards). It does not present a clinical study with acceptance criteria and reported device performance in the same manner one might expect for a diagnostic or therapeutic device requiring such evidence for market clearance.
Therefore, many of the requested elements cannot be extracted from the given document.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria for device performance in a clinical setting are provided, nor is there a table of reported device performance. The 510(k) emphasizes:
- Technological Comparison: The BAXOLVE™ is similar to the Smart-TENS in its delivery of the stimulation signal and similar parameter settings.
- Non-clinical Tests: Comparisons of electrical outputs for the two devices show similar results. Both were designed and independently tested to specific IEC and EN standards (e.g., IEC 60601-1:1990, IEC 60601-2-10, IEC 601-1-1, IEC 601-1-2, IEC 61000-4-2, IEC 61000-4-3, DD ENV 50204, EN 55011).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes non-clinical engineering and safety compliance tests, not a clinical study on human subjects with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical study with a test set and ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 Transcutaneous Electrical Nerve Stimulator (TENS) and a truncal orthosis, not an AI-assisted diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm. The device itself is the standalone product. The non-clinical tests focus on the device's electrical output and safety compliance, not its performance as an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" was adherence to established electrical output specifications and internationally recognized safety and electromagnetic compatibility standards (e.g., IEC 60601 series, EN 55011).
8. The sample size for the training set
Not applicable. This device does not involve machine learning or a training set in the AI context.
9. How the ground truth for the training set was established
Not applicable.
§ 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).