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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 disposable hydrogel electrode patch, an external pulse transmitter, an external pulse transmitter stimulation tester and a device used by the patient to wirelessly control the external pulse transmitter. The StimRouter Neuromodulation System is provided with three labeling documents: the Clinician's Guide, the Procedure Manual and the User's Guide. 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 external pulse transmitter 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 external pulse transmitter. The components of the Clinician Kit are a tablet PC with programming software that is capable of connecting to and configuring the external pulse transmitter. The User Kit contains the patient-use components of the StimRouter System. The components are the External Electric Field Conductor (E-EFC), an external pulse transmitter, with included charger and the StimRouter Electrode Carrying Case. After the E-EFC is programmed, the E-EFC can be connected to the StimRouter Electrode through which it can deliver stimulation transcutaneously to the implanted lead receiver.

The provided text describes a 510(k) premarket notification for the StimRouter Neuromodulation System, arguing for its substantial equivalence to a previously cleared predicate device (K200482). The submission primarily focuses on comparing the technological characteristics of the new device (modified StimRouter) with the predicate, rather than presenting a study with specific acceptance criteria and performance data for a standalone algorithmic device.

Therefore, many of the requested details about acceptance criteria, specific device performance metrics, sample sizes for test/training sets, ground truth establishment, and multi-reader multi-case studies are not available in the provided document. The document describes a comparison study, not a standalone performance study as would be typical for an AI/ML device.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document as specific numerical acceptance criteria and corresponding reported device performance for an algorithm's classification or prediction capabilities. The document describes a comparison of technical characteristics between the modified StimRouter and its predicate, rather than reporting performance against predefined acceptance criteria.

The "Equivalency Assessment" column in the table on pages 5-6 indicates similarity to the predicate and states that differences do not affect safety and effectiveness of intended use. For example:

• EWD Electrical Signal Transmitter: "Similar. The E-EFC circuitry is functionally equivalent to the EPT circuitry. The differences do not affect safety and effectiveness of intended use."
• EWD Phase Duration: "The reduction in number of positive phase duration values (due to a simplified code base) does not affect safety and effectiveness of the intended use because minor adjustments can be made to other parameters to create therapeutic programs equivalent to those provided by the EPT."
• EWD Max Compliance Voltage: The E-EFC's maximum compliance voltage increased to 130V from the predicate's 100V. The assessment states: "This difference in hardware does not affect safety and effectiveness of the intended use."

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. This document does not describe a study involving a test set of data for evaluating an AI/ML algorithm's performance. The "performance testing" mentioned on page 15 refers to electrical compatibility, wireless coexistence, biocompatibility, shipping, storage, shelf life, functional verification, usability, and software verification/validation—these are not related to a data-driven performance evaluation with a test set in the context of AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. As there is no described test set or ground truth establishment in the context of an AI/ML algorithm's performance, this information is not present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided.

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/Not provided. This submission is for a neuromodulation system, not an AI/ML diagnostic or assistive device that would involve human readers.

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

Not applicable/Not provided. The device described is a physical neuromodulation system, not a standalone algorithm. The software components are for controlling the device (CPS, MAPP app) and are evaluated through software verification and validation, not standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided.

8. The sample size for the training set

Not applicable/Not provided. No AI/ML training is described.

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

Not applicable/Not provided.

Summary of the Study Performed (as described in the document):

The "study" described in the 510(k) submission is a comparison of technological characteristics and performance testing to demonstrate substantial equivalence to a predicate device (StimRouter Neuromodulation System cleared in K200482).

The core of the submission (pages 5-6) is a detailed table comparing the "Subject Device (Modified StimRouter)" to the "Predicate (StimRouter cleared in K200482)" across numerous technical attributes, including:

• Manufacturer, 510(k) number, Intended use (all identical)
• Implantable Lead and Lead Introducer Kit components (packaging, lead characteristics, introduction method, tools) - indicated as "No changes" or "Same"
• User Kit accessories (External Electrical Field Conductor (E-EFC) vs. External Pulse Transmitter (EPT), MAPP Smartphone Application vs. Patient Programmer)
• Clinician Kit accessories (Modified Clinician's Programming Software (CPS) vs. original CPS)

The "Equivalency Assessment" column justifies why any differences (e.g., changes in electronics, wireless protocol, charging port, integrated controls, maximum compliance voltage, or phase duration values) do not affect the safety and effectiveness of the intended use, arguing that similar functionality is maintained or improved.

Performance Testing Mentioned (page 15):

The document lists "Performance Testing" categories that the StimRouter Neuromodulation System was qualified through:

• Electrical compatibility and safety
• Wireless coexistence
• Biocompatibility Testing
• Shipping and storage
• Shelf life
• Functional Verification
• Usability
• Software Verification and Validation Testing

These tests are standard for medical devices and demonstrate the device's adherence to relevant standards and its functional capabilities, rather than an AI/ML algorithm's data-driven performance. The document concludes that based on these comparisons and performance tests, the modified StimRouter is substantially equivalent to its predicate and does not raise new safety or effectiveness concerns.

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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. 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 StimRouter Neuromodulation System is provided with three labeling documents: the Clinician's Guide, the Procedure Manual and the User's Guide. Only the Procedure Manual has been modified to include an alternative implantation procedure for situations in which an open implantation of the implantable StimRouter Lead is indicated.

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 for a modified version of the StimRouter Neuromodulation System. It's a submission to the FDA to demonstrate substantial equivalence to a previously cleared device, not a report of a new clinical study proving effectiveness with specific acceptance criteria in the traditional sense of a clinical trial.

Therefore, many of the requested categories related to clinical study design, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable or directly provided in this type of regulatory document. This document focuses on demonstrating that a modification to an already cleared device does not introduce new questions of safety or effectiveness.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of quantitative acceptance criteria and reported device performance because it's a 510(k) submission for a modification to a previously cleared device (K190047). The primary "acceptance criterion" for a 510(k) is demonstrating "substantial equivalence" to a predicate device, which largely relies on showing that the modifications do not raise new questions of safety or effectiveness and that the technological characteristics are similar or that any differences do not affect safety or effectiveness.

The document states:

• "As noted in the Predicate Device Comparison Matrix below, other than the update of the Procedure Manual to include an alternative implantation procedure for situations in which an open implantation of the implantable StimRouter Lead is indicated, there are no other modifications with respect to the K190047 predicate all other technological characteristics are equivalent."
• "The new procedure is being provided for situations in which the surgical field has been previously opened and does not introduce additional risks to the patient. Also, the new method of placing the Lead allows for similarly effective stimulation of target nerve and receipt of stimulation from EPT."
• "Bioness Inc. concludes that the Risks vs. Benefits assessment remains unchanged, where the benefits accrued from the use of the device outweigh any identified residual risk."

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

• Sample Size: Not applicable. This document is not a clinical study report with a test set of patients. It's a regulatory submission for a device modification. The assessment is based on design controls and a comparison to a predicate device.
• Data Provenance: Not applicable for a traditional test set. The "data" used for this submission are the design specifications, risk analysis, and comparison to the predicate device's existing clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. There is no traditional "test set" of medical cases requiring ground truth established by experts in the context of this 510(k) submission for a modification. The assessment of the modification's impact is internal to the manufacturer's design control process and reviewed by the FDA.

4. Adjudication Method for the Test Set:

• Not applicable for the same reasons as #3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted to evaluate diagnostic devices or imaging systems where human readers interpret results, often with and without AI assistance. The StimRouter Neuromodulation System is a therapeutic implantable device, and this submission concerns a change in its implantation procedure.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. The StimRouter is a physical neuromodulation system, not an algorithm, and its use inherently involves human practitioners (implanting physicians and patient interaction with the programmer).

7. The Type of Ground Truth Used:

• The "ground truth" implicitly used here relies on the established safety and effectiveness of the predicate device (K190047) and the engineering and clinical assessment that the proposed modification (alternative implantation procedure) does not alter that established safety and effectiveness or introduce new risks. The risk assessment considers potential harms, but clinical outcomes data from a specific study for this modification is not presented as "ground truth."

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable for the same reasons as #8.

In summary: This document is an FDA 510(k) premarket notification for a modification to an existing medical device. It relies on demonstrating substantial equivalence to a predicate device, which is different from a clinical study that establishes performance against specific acceptance criteria for a novel device or AI algorithm. The focus here is on showing that the minor change (an alternative implantation procedure described in updated labeling) does not negatively impact the safety and effectiveness profile already established for the predicate device.

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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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