(169 days)
Electrical stimulation delivered by the device is intended for the symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain.
The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on acupressure points of a patient's feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain. Once these electrodes are placed, the machine determines the appropriate stimulation intensity by automatically measuring body temperatures through the use of two specially designed Thermistors placed on the fingers during a testing sequence. The VT-200 delivers four channels of current from dual output jacks through Treatment Leads and Electrodes which are positioned on the patient's body according to treatment protocols.
Here's an analysis of the provided 510(k) notification for the VT-200 Interferential Current Therapy Device, focusing on the acceptance criteria and the study that proves the device meets them:
Summary of Acceptance Criteria and Device Performance:
Based on the provided text, the VT-200 device's acceptance criteria primarily revolve around its substantial equivalence to a predicate device and its compliance with recognized safety standards. There are no performance metrics specified in terms of clinical efficacy (e.g., specific pain reduction percentages) that would commonly be found for drug trials or more complex medical devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Same intended use as the predicate device (Dynatron STS) | The VT-200 and Dynatron STS have the same intended use: symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain. |
| Functional Equivalence: Same functional characteristics as the predicate device. | The VT-200 has the same functional characteristics as the Dynatron STS, automating some manual portions using software. |
| Safety Compliance (Electrical): Compliance with IEC 60601-1 (General Requirements for Safety). | Performance testing indicates the device is in compliance with IEC 60601-1. |
| Safety Compliance (EMC): Compliance with IEC 60601-1-2 (Electromagnetic Compatibility - Requirements and Tests). | Performance testing indicates the device is in compliance with IEC 60601-1-2. |
Study Information:
It's important to note that the provided 510(k) summary does not describe a clinical study with human subjects to evaluate the therapeutic efficacy of the VT-200. Instead, it relies on proving substantial equivalence to a legally marketed predicate device (Dynatron STS) and demonstrating compliance with recognized electrical and electromagnetic safety standards.
Therefore, for categories related to clinical study design, sample size, ground truth, experts, and MRMC studies, the answer will be that this information is not applicable or not provided in the given document, as these types of studies were not conducted or reported for this 510(k) submission.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The "performance testing" mentioned refers to functional and design verification/validation against engineering standards, not a clinical test set with patient data.
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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 / Not provided. No clinical ground truth was established by experts for a test set in this submission.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No test set requiring expert adjudication was described.
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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:
- No, an MRMC study was not done. This device is an electrical stimulation therapy device, not an AI-assisted diagnostic or interpretation tool that would involve human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This question typically applies to AI/software as a medical device for diagnostic or interpretive purposes. The VT-200 is a physical therapy device; its "automation" refers to internal software logic for adjusting stimulation intensity, not a standalone diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided for clinical efficacy. For the engineering performance testing, the "ground truth" would be the specifications and requirements defined by the IEC standards.
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The sample size for the training set:
- Not applicable / Not provided. There is no mention of a "training set" in the context of machine learning or AI development for this device. The device's internal software "automatically measuring body temperatures" for intensity adjustment is a programmatic function, not a learned model in the typical AI sense that would require a training set.
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How the ground truth for the training set was established:
- Not applicable / Not provided. As no training set was described, the method for establishing its ground truth is also 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).