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For Spinal Cord Stimulation: This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

For Peripheral Nerve Stimulation: This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer than 30 day) to determine efficacy before recommendation for a permanent (long term) device.

The Nalu Neurostimulation System has been cleared by the FDA for spinal cord stimulation, and peripheral nerve stimulation (K201618), to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral, bilateral nerve pain. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord or peripheral nerve to inhibit the transmission of pain signals to the brain. The Nalu System is implanted only following a successful trial period using the Nalu Neurostimulation trial system. The Nalu Neurostimulation System consists of several components. The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads, to the desired location, either on the spinal cord or peripheral nerve site. The leads are implantable and designed to deliver electrical pulses to the nerves via an array of four or eight cylindrical electrodes at the distal end. The Trial Therapy Disc or the Therapy Disc houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer. Implantation of the Nalu IPG and lead components for spinal cord stimulation (SCS) or peripheral nerve stimulation (PNS) is performed via standard surgical tools and techniques, as described in (K201618).

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or performance metrics in the way one might expect for a diagnostic or AI-based device's clinical performance. Instead, the submission describes the Nalu Neurostimulation System and its substantial equivalence to predicate devices, focusing on technical specifications and safety rather than a measurable clinical outcome in a performance study.

The closest to "acceptance criteria" are the parameters defining the device's operational range, and the "reported device performance" is that these parameters are within acceptable limits compared to predicate devices, demonstrating substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical performance study with a "test set" from real patient data in the context of an AI/diagnostic device. Instead, it refers to "testing" performed to support the safety and performance of the device. This testing appears to be primarily non-clinical (bench/laboratory) testing of electrical and software parameters.

Therefore, there is no mention of a sample size for a test set of patient data, nor data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided. The study focuses on evaluating technical parameters against established medical device safety standards and comparison to predicate devices, not on a ground truth established by medical experts for diagnostic accuracy.

4. Adjudication Method

This information is not applicable and not provided, as the submission does not involve expert review or adjudication of clinical cases for diagnostic or performance accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is a neurostimulation system for pain relief, not a diagnostic imaging or AI-assisted diagnostic tool that would typically undergo MRMC studies to assess human reader improvement. The submission focuses on demonstrating substantial equivalence in technical characteristics and safety.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This concept is not directly applicable. The "device" itself (Nalu Neurostimulation System) is a therapeutic electrical stimulator. The "software" changes described are modifications to its operational parameters. The performance testing referenced is likely to evaluate the hardware and software functionality as an integrated system, ensuring it operates within safe and effective limits. There isn't an "algorithm only" component in the sense of an AI interpreting inputs to provide diagnostic outputs.

7. The type of ground truth used

The "ground truth" for this submission appears to be regulatory and engineering standards, and the specifications and performance characteristics of legally marketed predicate and reference devices. The evaluation focuses on whether the subject device's technical specifications and functionality (particularly the updated software parameters) fall within the established safe and effective ranges of these comparable devices.

8. The sample size for the training set

This information is not applicable and not provided. The device is not an AI/ML model that would train on a dataset. The software changes are operational programming changes for the neurostimulator.

9. How the ground truth for the training set was established

This information is not applicable and not provided, as there is no "training set" for an AI/ML model.

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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.

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.

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.

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