(275 days)
The STIMPOD NMS460 Nerve Stimulator is a Transcutaneous Electrical Nerve Stimulation (TENS) device used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment of post-surgical pain, post traumatic acute pain problems, as well as an adjunct for pain control due to rehabilitation.
The STIMPOD NMS460 Nerve Stimulator is a hand held low frequency neuromodulation Transcutaneous Electrical Nerve Stimulation (TENS) device, used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical pain, post traumatic acute pain, as well as an adjunct for pain control due to rehabilitation exercises. The STIMPOD NMS460 Nerve Stimulator offers two types of waveforms for the management of pain. The first is a Monophasic Square Wave, which is typical of normal TENS machines. The second waveform is a Hybrid RF waveform which consists of a Monophasic Square Wave with a superimposed Radio Frequency waveform. This waveform is proprietary and is unique to STIMPOD NMS460 Nerve Stimulator.
The provided document is a 510(k) summary for the STIMPOD NMS460 Nerve Stimulator. It focuses on demonstrating substantial equivalence to a predicate device (Acticare, K081835) rather than presenting a study to prove acceptance criteria in the traditional sense of clinical performance measures.
Here's an analysis of the requested information based on the document provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics that the device had to achieve (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it demonstrates an equivalence to a predicate device through technical characteristics and adherence to recognized electrical safety and EMC standards.
| Acceptance Criteria Category (Derived from document's focus) | Demonstrated Performance / Comparison |
|---|---|
| Intended Use | The STIMPOD NMS460 has a similar intended use (symptomatic relief and management of chronic intractable pain, adjunctive treatment of post-surgical/traumatic pain, and pain control due to rehabilitation exercises) to the predicate device. |
| Technical Characteristics Equivalence | The device's range of amplitudes, pulse widths, frequencies, and polarities are within the ranges delivered by the predicate device. |
| Electrical Safety | Complies with IEC 60601-1: 2005 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2: 2007 |
| Safety of Nerve and Muscle Stimulators | Complies with IEC 60601-2-10: 2015 |
| Biocompatibility | Materials (stainless steel, ABS plastic) have been previously used in medical devices (K093591) and are safe. |
| Worst-case Scenarios (Output) | For critical output parameters (e.g., peak current, average phase current, net charge, current density), the predicate device (Acticare) showed significantly higher values than the NMS460, suggesting the NMS460 operates within safer or comparable ranges. |
| RF Parameters (Hybrid RF Waveform) | The RF parameters of the NMS460 are within the range of RF parameters offered by the Acticare TSE. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical testing for electrical safety, EMC, and safety of nerve/muscle stimulators. It does not mention a "test set" in the context of patient data or clinical performance evaluation. The data provenance would be laboratory testing results against specified standards. Countries of origin for the device submission are South Africa and the USA (FDA).
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)
This information is not applicable as the submission relies on non-clinical engineering and safety standards testing, not on clinical performance evaluated against expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the submission relies on non-clinical engineering and safety standards testing, not on clinical performance evaluation requiring adjudication.
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
This information is not applicable. The device is a nerve stimulator for pain relief, not an AI-assisted diagnostic or interpretation device that would involve human "readers" or benefit from an MRMC study in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is hardware-based for electrical nerve stimulation, not an algorithm, and its use inherently involves human interaction for application and control.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" implicitly refers to the requirements and specifications within the cited international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10) regarding electrical safety, EMC, and specific nerve/muscle stimulator safety. There is no clinical "ground truth" such as pathology or outcomes data presented in this 510(k) summary.
8. The sample size for the training set
This information is not applicable. The device is not an AI/Machine Learning model that requires a training set. The submission focuses on device characteristics and compliance with standards.
9. How the ground truth for the training set was established
This information is not applicable. As stated above, there is no training set for an AI/Machine Learning model.
§ 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).