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The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.

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This FDA Premarket Notification (510(k)) K142432 for the StimRouter Neuromodulation System does not contain the detailed clinical study information requested.

Here's why and what's missing:

1. Nature of the Document: This is a 510(k) clearance letter. It states that the device is "substantially equivalent" to legally marketed predicate devices. This regulatory pathway typically relies heavily on demonstrating similarity to existing devices through design, materials, and often, non-clinical (bench and animal) testing, rather than extensive new human clinical trials to prove efficacy against specific acceptance criteria in the same way a PMA (Pre-Market Approval) would.

2. Focus of the Letter: The letter focuses on the FDA's regulatory decision and administrative details (registration, labeling, reporting, etc.). It does not include the detailed study report or clinical data that the manufacturer would have submitted.

Therefore, I cannot extract the following information from the provided text:

• 1. A table of acceptance criteria and the reported device performance: This information would be in a clinical study report, which is not present here.
• 2. Sample sized used for the test set and the data provenance: Not available in this document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
• 4. Adjudication method for the test set: Not available.
• 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 device is a neuromodulation system for pain, not an AI-powered diagnostic imaging tool. Thus, an MRMC study is not relevant and certainly not included.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Again, this is a directly implantable neuromodulation device, not an AI algorithm.
• 7. The type of ground truth used: Not applicable in the context of demonstrating substantial equivalence for a neuromodulation device in a 510(k). The "ground truth" would be the clinical outcome (pain reduction), but the document does not detail studies proving this with specific criteria.
• 8. The sample size for the training set: Not applicable as this is not an AI/machine learning device that uses training sets in the conventional sense.
• 9. How the ground truth for the training set was established: Not applicable.

What is available from the document:

• Device Name: StimRouter Neuromodulation System
• Indications for Use: Pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). Not intended to treat pain in the craniofacial region.
• Regulatory Class: Class II
• Product Code: GZF

To find the kind of detailed study information you're asking for, you would generally need to look for a clinical study report (CSR), a publication in a peer-reviewed journal, or a more detailed FDA document like a PMA review memo, which contains more in-depth data for devices requiring higher evidence. A 510(k) clearance letter itself does not provide this level of detail.

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