(218 days)
The TalisMann 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 TalisMann Neuromodulation System is not intended to treat pain in the craniofacial region.
The TalisMann Neuromodulation System is intended to provide electrical stimulation via an implanted lead to a target peripheral nerve, for aid in the pain management of adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The TalisMann Neuromodulation System is not intended to treat pain in the craniofacial region.
The TalisMann Neuromodulation System works by providing electrical impulses to a target area in the body. These impulses may interrupt or change the pain signals, inducing the feeling of tingling or numbness (paresthesia), and possibly reducing or replacing the feeling of pain.
The TalisMann Neuromodulation System consists of three main parts – the implantable StimRouter Lead (cleared most recently in K211965), the implantable TalisMann Pulse Generator/Receiver that is connected to the implantable Lead, and the external (to the body) components. The Lead is implanted with the stimulation end located at or near the targeted peripheral nerve, whereas the end with the Pulse Generator/Receiver is located near the skin surface. Accessories for the TalisMann include the Clinician Programmer with Software (CPS), the optional Mobile Application (MAPP) installed on a SmartPhone, the StimRouter Electrode (a disposable electrode patch, cleared most recently in K221965), and the TalisMann External Electrical Field Conductor (E-EFC).
The TalisMann System incorporates both commercially available and specially designed components. The materials used in the TalisMann Pulse Generator/Receiver and Lead have a long history of use in implanted devices; the insertion tools are also constructed from materials with a long history of surgical use. Materials in the external accessories are commonly used in both medical and non-medical applications. The powered components of the TalisMann System use commercially available IEC and UL approval rechargeable batteries. There are no components which are plugged into a wall socket during the use of the system by the patient.
The TalisMann uses the following components unchanged from the StimRouter System (K211965): the StimRouter Lead, the MAPP software, the E-EFC, and the StimRouter (Hydrogel Patch) Electrodes. The new components of the TalisMann System are: the TalisMann Pulse Generator/Receiver, new implant tools, and the updated Clinician Programmer Software (updated to enable TalisMann parameters).
The provided FDA 510(k) clearance letter and summary for the TalisMann Neuromodulation System does not contain the detailed acceptance criteria or a study proving that the device meets specific performance criteria in terms of accuracy, precision, or clinical efficacy.
The document primarily focuses on establishing substantial equivalence to predicate devices by comparing technological characteristics and listing the types of performance testing conducted for safety and effectiveness. It does not provide quantitative acceptance criteria for device performance nor the results of studies that would demonstrate the device meets such criteria.
The information provided confirms that the device underwent various forms of testing to demonstrate safety and general performance characteristics relative to its predicates, but not specific performance metrics such as accuracy or efficacy in pain relief that would typically have acceptance criteria.
Therefore, many of the requested fields cannot be filled based on the provided text.
Here's an analysis of what information is available and what is missing:
1. A table of acceptance criteria and the reported device performance
- Not provided. The document does not specify quantitative acceptance criteria for device performance (e.g., a specific percentage reduction in pain, or a certain accuracy for a diagnostic component). It focuses on direct comparisons of design and general safety/electrical parameters to predicate devices.
2. Sample size used for the test set and the data provenance
- Not provided for human clinical studies demonstrating efficacy.
- Animal Testing: Mentioned as "Acute and Long-term studies in porcine animal model" but sample size is not specified.
- Provenance: Not specified for any potential clinical data, as no clinical efficacy data is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. The document discusses performance testing for safety, electrical characteristics, software validation, and usability. It does not describe a test set requiring expert-established ground truth for a diagnostic or efficacy claim. Usability testing involved "Implanting Physician, Treating Clinician and Patient" but specific numbers or qualifications are not given.
4. Adjudication method for the test set
- Not applicable/Not provided. No adjudication method is mentioned as there isn't a stated clinical efficacy or diagnostic performance study requiring ground truth establishment through expert review.
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
- No. This device is a neuromodulation system for pain relief, not an AI-assisted diagnostic or imaging interpretation tool. Therefore, an MRMC study is not relevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an implanted neuromodulation system used by a patient, with programming by a clinician. It's not an algorithm that performs a standalone function without human interaction in its therapeutic application. Software verification and validation were performed for the E-EFC, MAPP, and CPS, which are components of the system, but this is a different type of "standalone" than algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated for efficacy/clinical performance. For safety and engineering tests, the "ground truth" would be established engineering standards, biocompatibility testing results, and functional requirements. For software, it would be validation against specified requirements. No specific clinical outcomes data or pathology as a "ground truth" for device efficacy is mentioned in the context of performance criteria.
8. The sample size for the training set
- Not applicable/Not provided. The device is not described as involving machine learning or AI models that would require a "training set" in the traditional sense for an algorithmic performance claim.
9. How the ground truth for the training set was established
- Not applicable/Not provided. (See point 8).
Summary of what is present:
The document outlines a substantial equivalence argument based on:
- Comparison of Indications for Use: Similar to predicates for severe intractable chronic peripheral nerve pain, excluding craniofacial region.
- Comparison of Technological Characteristics: Detailed tables comparing the subject device (TalisMann Neuromodulation System) to three predicate devices (StimRouter, Nalu, Renew) across components like transmitter/receiver, leads, externally worn devices, clinician programmer, and patient remote control. These comparisons highlight similarities in mode of action, implant site, power sources, stimulation parameters (frequency, duration, charge, power), materials, and software configuration.
- Performance Testing Categories: A list of testing performed to support safety and effectiveness, including:
- Labeling Validation
- Software verification and validation (for E-EFC, MAPP, and CPS)
- EMC, Wireless Co-Existence, and Electrical Safety
- Usability testing (for Implanting Physician, Treating Clinician, and Patient)
- Bench testing (TalisMann implant, external modules, system testing)
- Animal testing (Acute and Long-term studies in porcine model)
- Sterilization and Shelf Life
- Biocompatibility
Conclusion based on the provided text:
The FDA 510(k) clearance letter focuses on establishing substantial equivalence for the TalisMann Neuromodulation System by demonstrating that its technological characteristics, intended use, and performance testing (with a focus on safety and established engineering principles) are comparable to legally marketed predicate devices. It does not present a study with specific, quantitative acceptance criteria for clinical performance or efficacy metrics against which the device's performance is measured and reported. The "performance testing" described is primarily geared towards validating individual components and system safety/functionality rather than an overarching clinical effectiveness study with defined endpoints and acceptance criteria in the context often seen for diagnostic or AI-driven devices.
§ 882.5870 Implanted peripheral nerve stimulator for pain relief.
(a)
Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).