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510(k) Data Aggregation
(783 days)
TENS mode:
- Symptomatic relief of chronic (long term) intractable pain
- Symptomatic relief of post-tramautic acute pain and post surgical pain
Russian mode:
- Temporary relaxation of muscle spasms in back area
- Prevention or retardation of disuse atrophy of the lumbar paraspinal muscles
The StimaWELL 120MTRS has been designed for the use of medium frequency electro-therapy for muscle stimulation and pain relief therapy as well as for the warming and wellness application in the back region.
The device consists of a 12 channel (electrodes) Stimulation Mat, a Controller and a Remote Control Unit. Various accessories (see 11.3.2 below) support the StimaWELL. The warming is provided through controlled resistive heating of the stimulation mat.
Interaction with the device is via a touchscreen on the controller. Selection and set-up of various treatment sequences is via the controller touchscreen or can be recalled from chip cards. The patient can interact with the device by using the remote control unit. With that he can pause the treatment at any time and also adjust the overall intensity.
The Pierenkemper GmbH StimaWELL 120MTRS, a transcutaneous electrical nerve stimulator for pain relief and powered muscle stimulator, has demonstrated comparable performance to its predicate device, the Neurodyn II.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't provide specific quantitative "acceptance criteria" in the format of a table with numerical thresholds for performance metrics. Instead, "acceptance" is demonstrated through compliance with recognized electrical safety, electromagnetic compatibility, biocompatibility, risk management, software, and usability standards, and by showing substantial equivalence to the predicate device in terms of indications for use, technological characteristics, and output specifications.
The reported device performance is presented as "Passed" for all listed tests and a detailed comparison of output specifications to the predicate device.
| Test/Characteristic | Acceptance Criteria (Implied by Standards/Predicate) | Reported Device Performance (StimaWELL 120MTRS) |
|---|---|---|
| Non-Clinical Performance Data | ||
| Electrical safety | Compliance to IEC 60601-1:2005/AMD1:2012 | Passed |
| Electromagnetic compatibility | Compliance to IEC 60601-1-2:2014 | Passed |
| Nerve and muscle stimulators | Compliance to IEC 60601-2-10:2012 | Passed |
| Biocompatibility | Compliance to ISO 10993-1, ISO 10993-5:2009, and ISO 10993-10:2002 | Passed |
| Risk Management | Compliance to ISO 14971:2007 | Passed |
| Software | Compliance to IEC 62304:2006 | Passed |
| Usability | Compliance to IEC 62366:2007 (Ed. 1) + A1: 2014 and EN 60601-1-6:2013 | Passed |
| Output Specifications (TENS Mode) | (Comparable to Neurodyn II, where publicly available) | |
| Waveform | Biphasic (predicate not publicly available) | Biphasic |
| Shape | Rectangular (predicate not publicly available) | Rectangular |
| Max Output Voltage @ 500 Ω | Not publicly available for predicate | 58.7 Vpp (+/- 10 %) |
| Max Output Current @ 500 Ω | 124mA (predicate) | 58.7 mA (+/- 10 %) |
| Pulse Width | Not publicly available for predicate | 500 ms to 5 ms |
| Frequency (Hz) | 0.5 Hz to 250 Hz (predicate) | 1 Hz to 100 Hz |
| Max Current Density @ 500 Ω | Not publicly available for predicate | 3.87 mA/cm² |
| Max Power Density @ 500 Ω | 0.038 W/cm² (predicate) | 0.11 W/cm² |
| Output Specifications (Russian Mode) | (Comparable to Neurodyn II, where publicly available) | |
| Waveform | Biphasic (predicate not publicly available) | Biphasic |
| Shape | Rectangular (predicate not publicly available) | Rectangular |
| Max Output Voltage @ 500 Ω | Not publicly available for predicate | 62.7 Vpp (+/- 10 %) |
| Max Output Current @ 500 Ω | 124mA (predicate) | 62.7 mAp (+/- 10 %) |
| Pulse Width | Not publicly available for predicate | 500 ms to 5 ms |
| Frequency (Hz) | 0.5 Hz to 250 Hz (predicate) | 1 Hz to 100 Hz |
| Max Current Density @ 500 Ω | Not publicly available for predicate | 4.13 mA/cm² |
| Max Power Density @ 500 Ω | 0.038 W/cm² (predicate) | 0.13 W/cm² |
2. Sample size used for the test set and the data provenance:
The document describes non-clinical bench testing rather than clinical studies with human subjects. Therefore, there is no "test set" in the sense of patient data. The tests were performed on the device itself against established standards and internal requirements. Data provenance would be from laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable in the context of this submission. The ground truth for device performance is based on compliance with harmonized standards (e.g., IEC, ISO) and internal development processes, rather than expert consensus on patient data.
4. Adjudication method for the test set:
Not applicable, as this was non-clinical bench testing against established standards, not a review of clinical outcomes by experts.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. This device is a medical device for electrical stimulation (TENS and Russian mode), and the submission focuses on demonstrating substantial equivalence through technical specifications and compliance with safety standards, not through comparative effectiveness studies with human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This device is not an AI algorithm. It is a physical medical device that provides electrical stimulation. Therefore, the concept of "standalone (algorithm only)" performance does not apply.
7. The type of ground truth used:
The "ground truth" for the device's performance is established by compliance with recognized national and international standards for electrical safety, electromagnetic compatibility, biocompatibility, risk management, software, and usability (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-1, ISO 14971, IEC 62304, IEC 62366). Also, the comparison to the technical specifications and indications for use of a legally marketed predicate device (Neurodyn II) forms the basis for demonstrating substantial equivalence.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning or AI device.
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