(219 days)
The StimTrial System is indicated for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for the StimRouter Neuromodulation System's permanent (long term) implant indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy used in a multidisciplinary approach and not intended to treat pain in the craniofacial region.
The StimTrial Neuromodulation System is to be used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) implant for a system indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy used in a multidisciplinary approach and not intended to treat pain of craniofacial nerve origin.
The StimTrial Neuromodulation System is intended to help determine patient candidacy for a permanent implant to help manage pain of peripheral nerve origin. The StimTrial System works by sending electrical impulses from an external stimulator to a lead that is percutaneously placed next to a target nerve. These impulses are intended to interrupt or change the pain signals, inducing the feeling of tingling or numbness (paresthesia), and possibly reducing or replacing the feeling of pain.
The StimTrial Neuromodulation System consists of three main parts - the percutaneous StimTrial Lead, the StimTrial Lead Adaptor Cable, and the StimTrial External Stimulator. The StimTrial Lead is percutaneously placed with the distal, stimulating end located at or near the targeted peripheral nerve and with the proximal end remaining outside of the body for the trial duration. The StimTrial Lead Adaptor Cable is an external cable that directly connects the StimTrial Lead to the StimTrial External Stimulator providing a direct electrical pathway from the External Stimulator to the Lead. The StimTrial External Stimulator is a device which, when connected to the Lead Adaptor Cable and the StimRouter Electrode (a hydrogel patch electrode) attached to the skin near the implant site, generates electrical stimulation pulses that travel to the StimTrial Lead. Accessories for the StimTrial System include the StimRouter Electrode (a disposable electrode patch, cleared most recently in K211965), the StimTrial Clinician Programmer with Software (CPS) and the optional StimTrial Mobile Application (MAPP) installed on a Smartphone.
The StimTrial System incorporates both commercially available and specially designed components. The materials used in the StimTrial 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 StimTrial 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.
This document outlines the acceptance criteria and the study conducted to prove that the StimTrial Neuromodulation System meets these criteria, based on the provided FDA 510(k) Clearance Letter.
Summary of Device Performance Study Information:
The provided document details various performance tests conducted for the StimTrial Neuromodulation System, but it does not include a clinical study with specific acceptance criteria and reported performance metrics in the format typically used for demonstrating efficacy or performance against a clinical endpoint (e.g., accuracy, sensitivity, specificity, or improvement in patient outcomes).
Instead, the listed "Performance Testing" are focused on engineering, safety, and regulatory compliance aspects:
- Labeling Validation
- Software verification and validation (for External Stimulator, MAPP and CPS software devices)
- EMC, Wireless Co-Existence and Electrical Safety
- Usability testing (for Implanting Physician, Treating Clinician and Patient)
- Bench testing (Tests of the StimTrial Lead, External Stimulator, StimTrial System)
- Animal testing (Acute and Long-term studies in porcine animal model)
- Sterilization and Shelf Life (StimTrial Surgical Kit)
- Biocompatibility (for StimTrial Lead, Insertion Tools and External Stimulator)
This type of submission for a Class II device like a neuromodulation system for trial stimulation often relies heavily on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing. The purpose of this "StimTrial System" is for trial stimulation to determine efficacy before a permanent implant, meaning its primary function in this context is to safely and effectively deliver electrical stimulation within defined parameters to aid in patient selection for a long-term device. It is not an AI/ML powered device, so many of the questions regarding ground truth, expert adjudication, MRMC studies, and training/test set sample sizes are not directly applicable in the typical sense of an AI/ML performance study.
Given the information, a detailed table of "acceptance criteria and reported device performance" related to clinical efficacy or AI/ML performance metrics cannot be constructed from the provided text. The "acceptance criteria" for a 510(k) clearance in this context primarily revolve around demonstrating that the device is as safe and effective as its predicate devices, which is achieved through the enumerated non-clinical tests and technical comparisons.
However, answering the questions as best as possible based on the implied purpose of such a device and the provided text:
Implied Acceptance Criteria and Study to Prove Device Meets Criteria (Based on information provided)
The "StimTrial Neuromodulation System" is a medical device for trial stimulation. Its acceptance criteria are implicitly tied to demonstrating safety and performance characteristics that are substantially equivalent to legally marketed predicate devices, as this is a 510(k) submission. The study proving this typically involves a combination of bench testing, software validation, biocompatibility, and animal studies, rather than large-scale clinical trials for efficacy.
1. Table of Acceptance Criteria and Reported Device Performance:
Since the document focuses on demonstrating substantial equivalence through technical specifications and non-clinical testing rather than clinical performance metrics, a table of "acceptance criteria" for a clinical outcome (e.g., sensitivity, specificity, accuracy) is not present. The acceptance criteria relate to meeting specific engineering, safety, and biocompatibility standards, and these are largely reported as successful completion of the tests mentioned in Section VII.
| Category/Test | Acceptance Criteria (Implied) | Reported Performance (Implied from "Conclusion") |
|---|---|---|
| Labeling Validation | Labeling is clear, accurate, and compliant with regulatory requirements. | Successfully completed. |
| Software Verification & Validation | Software (External Stimulator, MAPP, CPS) functions as intended, is safe, secure, and reliable. | Successfully completed. |
| EMC, Wireless Co-existence, Electrical Safety | Device meets relevant electrical, electromagnetic compatibility, and wireless co-existence standards. | Successfully completed. |
| Usability Testing | Device can be used safely and effectively by intended users (Physician, Clinician, Patient) without excessive errors. | Successfully completed. |
| Bench Testing (Lead, Stimulator, System) | Device components and system meet all defined performance specifications (e.g., stimulation parameters: amplitude, frequency, pulse width, charge, current density are within acceptable ranges and comparable to predicates). | Successfully completed. (Comparison tables in Section VI support this). For instance, Amplitude (max) 10mA, Pulse frequency 1-200 Hz, Pulse width 100-500 µsec, Max charge per pulse 5.0 µC, etc., are within ranges of predicates. |
| Animal Testing (Acute & Long-term) | Device performance and tissue response are acceptable over the trial duration (up to 30 days) in a relevant animal model. No unacceptable adverse biological effects. | Successfully completed (in porcine model). |
| Sterilization & Shelf Life | Device remains sterile and functional over its stated shelf life. | Successfully completed. |
| Biocompatibility | Device materials in contact with the body are biocompatible. | Successfully completed. |
| Substantial Equivalence (Overall) | The device is as safe and effective as predicate devices and does not raise new safety or effectiveness concerns. | Bioventus concludes the StimTrial System is substantially equivalent to the Nalu Neurostimulation System predicate device and does not raise any new issues or concerns of safety or effectiveness. (Section VIII) |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify a "test set" in the context of a clinical study for performance evaluation (e.g., accuracy of diagnosis). The "tests" performed are largely engineering validations or animal studies.
- For Animal Testing, "Acute and Long-term studies in porcine animal model" were conducted. The specific number of animals is not stated.
- For Usability Testing, the number of "Implanting Physician, Treating Clinician and Patient" participants is not specified.
- For Bench Testing, the number of units or tests performed is not specified, but it implies a sufficient number to validate performance.
- Data Provenance: Not explicitly stated for any clinical data as it's not a clinical performance study. Animal studies are typically conducted in a controlled lab environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable in the typical sense of AI/ML ground truth establishment. The "ground truth" for this device's performance would be established by objective measurements in bench testing (e.g., output electrical parameters matching specifications), and pathological/physiological observations in animal models (e.g., tissue response). These are based on established engineering and biological standards, not human expert consensus on interpretations of images or signals.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of human-interpreted data that would require an adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement with AI vs. Without AI Assistance:
Not applicable. This device is a neuromodulation system, not an AI/ML algorithm for diagnostic or prognostic purposes, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This device is a physical neuromodulation system with accompanying software for control, not a standalone algorithm for independent task execution (like image analysis). Its function inherently involves human-in-the-loop operation (clinician programming, patient use).
7. The Type of Ground Truth Used:
The "ground truth" for the various performance tests would be:
- Bench Testing: Engineering specifications and physical measurements (e.g., electrical parameter values, mechanical properties).
- Biocompatibility: ISO standards for medical device materials.
- Sterilization: Sterility assurance levels (SAL) based on validated methods.
- Animal Testing: Histopathological analysis of tissues, physiological responses, and adverse event monitoring.
8. The Sample Size for the Training Set:
Not applicable. This device does not involve a machine learning component that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/ML model.
§ 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).