(295 days)
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.
The StimRouter Neuromodulation System consists of two main parts - the implantable lead, and the external (to the body) accessories for the StimRouter include a clinician programmer with software (CPS), a patient programmer, disposable hydrogel electrode patch, external pulse transmitter (EPT), and an EPT stimulation tester (EPTT).
The Bioness StimRouter Neuromodulation System is intended to provide electrical stimulation via an implanted lead to a target peripheral nerve, for aid in the management of severe, intractable, chronic pain of peripheral nerve origin in adults, as an adjunct to other modes of therapy (e.g. medications). The StimRouter is not intended to treat pain in the craniofacial region.
The complete StimRouter System consists of three kits: A Lead and Lead Introducer Kit, a Clinician Kit and User Kit. The Lead Kit contains the StimRouter implantable multielectrode lead with integrated receiver, used for peripheral nerve stimulation. The Lead receives an electrical signal transmitted transcutaneously by the EPT which is mounted on an electrode patch on the skin and delivers that electrical signal down the lead's length to a target peripheral nerve. The Lead is supplied in Lead Loader that is used during intraoperative testing of the lead and to verify proper placement during implantation.
The Lead and lead Introducer Kit consists of two stimulation probes, two stimulation cables, and introducer set, a lead adapter, a Tunneling Needle and a Tunneling Needle Stylet. The included tools and components allow for insertion of the StimRouter Lead and confirmation of optimal location of the stimulation electrode contacts of the StimRouter Lead.
The Clinician Kit is used for the programming of the StimRouter patient programmer and the EPT. The components of the Clinician Kit are a tablet PC with programming software and the accessories for connecting to the Patient Programmer and the EPT.
The User Kit contains the patient-use components of the StimRouter System. The components are the Patient Programmer and the EPT. After the EPT is programmed, the StimRouter electrode interfaces with the EPT and function to delivery stimulation to the implanted lead receiver.
This document is a 510(k) Premarket Notification from Bioness Inc. for their StimRouter Neuromodulation System. It's a submission to the FDA requesting clearance to market a modified version of an already cleared device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to a predicate device, rather than proving clinical efficacy from scratch as one might for a novel AI device or drug.
Based on the provided text, the device is a neuromodulation system for pain management, not an AI/ML diagnostic tool. Therefore, the questions related to AI/ML specific criteria (number of experts, MRMC studies, ground truth for training/test sets, effect size of human readers with/without AI, standalone performance) are not directly applicable.
However, I can extract information related to the device's technical specifications and the testing performed to demonstrate its safety and effectiveness, which are the "acceptance criteria" in the context of a 510(k) submission for a medical device modification.
Device: StimRouter Neuromodulation System (modified version)
Type of Submission: 510(k) Premarket Notification for a modification to a previously cleared device (K142432).
Key Goal of the Study: To demonstrate substantial equivalence of the modified StimRouter Neuromodulation System to its predicate device (original StimRouter, K142432) in terms of safety and effectiveness. This is achieved by showing that the modifications do not raise new questions of safety or effectiveness and that the device performs as intended.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the safety and performance standards expected for an implanted peripheral nerve stimulator and the comparison to the predicate device. The "reported device performance" is demonstrated through various verification and validation activities and comparison of technical characteristics.
| Acceptance Criteria (Implicit from 510(k) Process) | Reported Device Performance (as demonstrated by comparison and testing) |
|---|---|
| Functional Equivalence to Predicate Device | Most technical characteristics are "Same" as the predicate (e.g., intended use, manufacturer, lead design, number of electrodes, electrode shape, materials, lead length, body diameter, implantation method, stimulation probe, cables, introducer set, lead adaptor, gel electrodes, EPT power source, EPT location, EPT communication, EPT pulse frequency, EPT pulse width, waveform, stimulation modality, patient programmer programs, patient selectable programs, programmer communication, software driven, multiple stim modes, GUI, StimRouter Electrodes) |
| Safety of Modified Components/Parameters: | |
| - Packaging (consolidation of kits, material change) | Similar; New packaging is consolidation; PETE (new material) confirmed equivalent through qualification, has better impact resistance than PETG (old material). |
| - Tray Lid Adhesive | Similar; New adhesive confirmed equivalent through qualification. |
| - Increased Maximum Charge per Pulse (Lead) & Maximum Charge Density (Lead) | Similar; Safety maintained because of limits on max current (30mA) and max pulse duration (500µsec). Values are lower than other similar devices and comply with safety requirements. Detailed comparison table shows values are within safe ranges of reference predicate devices (Medtronic PNS, Renew System). |
| - Tunneling Needle Material (removal of nickel plating) | Similar; Safety maintained; Nickel was previously used for soldering ease, but adequate soldering without nickel was confirmed by the vendor for the subject device. Addresses nickel allergy warning. |
| - Clinician's Programmer Hardware (new off-the-shelf tablet) | Similar; Physically larger but runs substantially equivalent software (recompiled). |
| - Clinician Programmer Operating System (Windows Mobile 5 to Windows 10 Home) | Similar; Same code can run in Windows 10 Home. |
| - Clinician Programmer GUI (adjusted to fit larger screen) | Similar; Same GUI contents. |
| - Added Stimulation Frequencies (12, 15 Hz) | Similar; New frequencies are within the original stimulation range. |
| - Patient Log Export Function (software enhancement) | Similar; Minor change that just adds a function. |
| - Miscellaneous Clinician Software Enhancements (obsolete buffering, co-installation) | Similar; Minor enhancements to code that do not change function. |
| - Ramp Down Feature (EPT) | Similar; Provides smooth transition for patient comfort. Expected to have same paresthesia effect. |
| - Maximum Compliance Voltage (EPT: 90V to 100V) | Similar; Safety maintained because of limits on max current (30mA) and max EPT external temperature (41°C). Aims to treat patients with high skin impedance or requiring higher current. |
| - Charge per Phase Limit (EPT: 10 µC to 15 µC due to rechargeable batteries) | Similar; Safety maintained because of limits on max current (30mA) and max pulse duration (500µsec). The previous 10 µC limit was due to non-rechargeable battery needs, which are no longer supported. |
| - Miscellaneous EPT Software Enhancements (transistor disconnection, impedance) | Similar; Updates provide better detection of conditions and unnecessary termination of stimulation. |
| - Miscellaneous Patient Programmer Software Enhancements (interfering EPTs, buggy RF channels) | Similar; Software updates improve reliability of connection with EPT. |
| Verification & Validation Testing Compliance | Risk Analysis methods were used to assess impact of modifications and determine required V&V activities. Extensive bench tests were conducted, including: Bioburden, Sterilization & Shelf-life, Biocompatibility, Shelf Life, Shipping Validation, Package Integrity (Bubble Leak, Seal Strength), Functional V&V, Label Validation, Printing Verification, MRI Compatibility, Implant Heating, and Software V&V Testing. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: Not explicitly stated as a number of devices/patients for a clinical trial. For a 510(k) modification where substantial equivalence is demonstrated through bench testing and comparison, the "sample size" refers to the number of units tested for each specific bench test (e.g., a certain number of devices for shelf-life testing, a certain number for functional testing). These specific numbers are not provided in this summary.
- Data Provenance: The document does not specify a country of origin for any human data (as no clinical trial data is summarized). The data primarily comes from bench testing and technical comparisons against historical predicate device data and reference devices. The submission indicates that these tests were "originally developed under the design control process of the StimRouter Neuromodulation System cleared in K142432," suggesting these are in-house engineering and lab tests. The nature of the submission (Special 510(k)) indicates that new clinical data is generally not required if performance is demonstrated through other means.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- This is not applicable as the submission relates to a physical medical device modification, not an AI/ML algorithm requiring expert annotation for ground truth. Ground truth for device performance is established through engineering specifications, material science, and safety standards, not subjective expert assessment of images or clinical outcomes in the same way as an AI diagnostic.
4. Adjudication Method for the Test Set:
- Not applicable for a device modification validated through bench testing and technical comparison. Clinical study adjudication methods (e.g., 2+1, 3+1) are for human-in-the-loop diagnostic studies or clinical outcome studies.
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:
- Not applicable. This is a medical device (neuromodulation system) and not an AI-assisted diagnostic tool. No MRMC study was conducted or required for this type of submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. Its "standalone performance" is related to its physical and functional operation as a stimulator, which is evaluated through the listed bench tests.
7. The Type of Ground Truth Used:
- The "ground truth" for this submission are the performance specifications, safety limits (e.g., charge density, current limits), and accepted medical device standards (e.g., biocompatibility standards, sterilization standards, electrical safety standards).
- For the comparative analysis, the performance characteristics of the cleared predicate device (K142432) and other reference devices (Medtronic PNS, Renew System) serve as the "ground truth" or benchmark for substantial equivalence.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
§ 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).