(240 days)
The J-Stim 1000 is indicated for use as an adjuctive therapy in reducing the level of pain and symptoms associated with Osteoarthritis of the knee and Rheumatoid Arthritis of the Hand.
The J-Stim 1000 external, non-invasive, non-narcotic, electrotherapy system is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee and for overall improvement of the knee.
The J-Stim 1000 is also indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand.
The J-Stim 1000 consists of electrodes, the lead wires, and the signal generator. The Stimulator is portable, battery operated and rechargeable. The Lead wires connect the electrodes to the stimulator. These electrodes complete an electrical circuit allowing current to flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.
The provided text is a 510(k) summary for the J-Stim 1000™, a Transcutaneous Electrical Nerve Stimulator (TENS) device. The document primarily focuses on establishing substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics.
Based only on the provided text, here's what can be extracted and what information is not available:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., specific pain reduction percentages, range of motion improvements, or statistical significance levels) for the J-Stim 1000™.
Instead, the core of the submission revolves around establishing substantial equivalence to a predicate device, the Bionicare Stimulator, Model Bio 1000 (K030332). The "performance" reported is that the J-Stim 1000™ has identical electrical output compared to the predicate device.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (J-Stim 1000™) |
|---|---|
| Electrically identical to Bionicare 1000 predicate device (K030332) | Produces the same frequency |
| Produces the same waveform (monophasic spiked shaped pulse) | |
| Produces the same voltage output range (0-12 volts peak) | |
| Same dual channel output performance | |
| Identical pulse widths | |
| Identical maximum output values | |
| Indicated for use as an adjunctive therapy in reducing pain and symptoms associated with osteoarthritis of the knee and rheumatoid arthritis of the hand. | Intended use statement matches the predicate device's implied performance for these conditions. |
2. Sample size used for the test set and the data provenance:
The provided document does not describe any new clinical study or test set with human subjects that directly tested the J-Stim 1000™. The submission hinges on the established performance of the predicate device (Bionicare Stimulator, Model Bio 1000). Therefore, there is no sample size for a test set, nor is there data provenance mentioned for such a study in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since no new clinical study or test set for the J-Stim 1000™ is described, there is no information on experts used to establish ground truth.
4. Adjudication method for the test set:
As no new clinical study or test set for the J-Stim 1000™ is described, there is no information on an adjudication method.
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 question is not applicable to the J-Stim 1000™ TENS device. AI assistance and human reader improvement are concepts typically associated with diagnostic imaging or decision support systems, not with a TENS device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This question is not applicable to the J-Stim 1000™ TENS device. It is a physical device that delivers electrical stimulation, not an algorithm.
7. The type of ground truth used:
For the purpose of this 510(k) submission, the "ground truth" for demonstrating the J-Stim 1000™'s effectiveness is established by the prior approval of the predicate device (Bionicare Stimulator, Model Bio 1000). The assumption is that because the J-Stim 1000™ is "electrically identical" to the predicate, it will have comparable therapeutic effects for the stated indications.
8. The sample size for the training set:
There is no mention of a training set in this document as it does not describe the development or testing of an algorithm, but rather a medical device seeking substantial equivalence based on its physical and electrical characteristics.
9. How the ground truth for the training set was established:
As no training set is mentioned, there is no information on how its ground truth was established.
§ 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).