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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.

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.

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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.

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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 days) to determine efficacy before recommendation for a permanent (long term) device.

The Nalu Neurostimulation System for Peripheral Nerve Stimulation (also referred to as the "Nalu System") is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Nalu System incorporates a miniature implantable pulse generator, powered by an externally worn Therapy Disc device. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on the peripheral nerves to inhibit the transmission of pain signals to the brain. The Nalu System may be implanted following a successful trial period using the Nalu Neurostimulation trial system. The Nalu System is comprised of 5 elements: Nalu Implantable Pulse Generator, Leads, Surgical and Trial Tools, Externally worn Therapy Disc, and Clinician Programmer and Remote Control.

This document describes a 510(k) premarket notification for the Nalu Neurostimulation System for Peripheral Nerve Stimulation. The submission aims to establish substantial equivalence to a previously cleared predicate device (K183579), primarily focusing on an update to the device's Magnetic Resonance (MR) Conditional Labeling to include full body scans.

Based on the provided text, there is no acceptance criteria table or specific study performance data for a device meeting acceptance criteria in the traditional sense of an AI/ML model for diagnostic or predictive purposes. This document is a regulatory submission for a physical medical device (implantable neurostimulator) and its associated external components and software, not an AI/ML diagnostic software. The "performance" discussed here relates to the safety and functionality of the device itself, particularly its compatibility with MRI, rather than the accuracy of a diagnostic algorithm.

Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the device's "performance" as presented in the context of this 510(k) submission, specifically concerning the MRI compatibility, as this is the primary change necessitating the resubmission.

Summary of Acceptance Criteria and Device (MRI) Performance:

Since this is not an AI/ML diagnostic device, the "acceptance criteria" are not framed in terms of metrics like accuracy, sensitivity, or specificity. Instead, they are related to established safety standards for medical devices, particularly regarding MRI compatibility. The "device performance" refers to the results of testing performed to ensure these safety standards are met.

1. Table of Acceptance Criteria and Reported Device Performance (Focusing on MRI Compatibility):

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

• Sample Size: The document does not specify the sample sizes used for the engineering tests (e.g., number of devices tested for MRI compatibility, displacement, torque, or artifacts). These are typically bench tests on physical units, not clinical data sets.
• Data Provenance: Not applicable in the context of clinical data. The tests are laboratory-based, non-clinical performance and bench testing.

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

• Not Applicable. This is not a study assessing the performance of a diagnostic algorithm where expert ground truth is established for medical images. The "ground truth" for this device's performance relies on engineering measurements and adherence to international and national standards (e.g., ISO, ASTM) for device safety and functionality.

4. Adjudication Method for the Test Set:

• Not Applicable. As there are no human readers or diagnostic interpretations involved in the "test set" (which consists of physical device tests), no adjudication method is necessary.

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

• No. This type of study is typically done for diagnostic imaging devices or AI tools that assist human readers. This submission is for an implantable neurostimulation system, not a diagnostic imaging or AI assistance tool.

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

• Not Applicable. There is no "algorithm only" performance being evaluated in this submission in the context of diagnostic AI. The device's functionality (e.g., electrical stimulation parameters) and safety (e.g., MRI compatibility) are evaluated.

7. The Type of Ground Truth Used:

• The "ground truth" for the device's safety and performance is established through adherence to recognized international and national consensus standards (e.g., ISO/TS 10974, ISO 14708, ASTM F2052-15, ASTM F2213-17, ASTM F2119-2013) and engineering verification and validation testing. It is not based on expert consensus on medical image interpretations or clinical outcomes data in the context of diagnostic accuracy.

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. (See point 8).

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The Freedom Peripheral Nerve Stimulator (PNS) 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 Freedom Trial Lead Kit is only to be used in conjunction with the Freedom Neurostimulator Kit. The trial devices are solely used for a trial stimulation period (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The Freedom PNS System uses HF-EMC (High Frequency Electromagnetic Coupling) neurostimulation technology to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Freedom PNS System is comprised of a two-component implantable neurostimulator, an externallyworn transmitter, and WaveCrest software used to set patient-specific stimulation programs. The system's mechanism of action relies on programmable pulsed electrical current to create an energy field that acts on the targeted peripheral nerve to inhibit the transmission of pain signals to the brain. The two-component neurostimulator, comprised of an electrode array and a separate receiver, are surgically connected and anchored within two separate incisions, including creation of a subcutaneous pocket. The stimulation program is adjusted as needed to provide pain relief for the patient. The purpose of this submission is to modify the indications for use for the existing system (K171366) to include craniofacial applications.

The Freedom PNS System is a single-use, prescription-only system, to be implanted by an appropriate clinician, such as a neurosurgeon, interventional pain physicial surgeon or orthopedic surgeon.

The provided text describes the acceptance criteria and the study conducted for the Freedom Peripheral Nerve Stimulator (PNS) System (K233162) to support the expansion of its indications for use to include craniofacial applications.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 60 patients were implanted with the Freedom® PNS system. Of these, 58 completed the 7-day confirmation visit. 56 of these 58 responders were randomized to either the Active (Treatment group) or Deactivated (Control group).
  • Treatment/Active group: 28 patients
  • Control/Deactivated group: 28 patients
• Data Provenance: The study was a "multi-center randomized clinical trial." The country of origin is not specified in the provided text, but "clinical data" and "multi-center randomized clinical trial" imply prospective data collection in a clinical setting.

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

The study described is a clinical trial assessing the effectiveness of a pain management device. The "ground truth" for effectiveness in this context is self-reported pain relief from the patients themselves, and safety is determined by the occurrence of serious adverse events. Therefore, there's no mention of a traditional expert panel establishing "ground truth" in the same way it would be for, say, image interpretation. The efficacy is based on patient outcomes as measured against the specified endpoints.

4. Adjudication Method for the Test Set

Not applicable in the context of this clinical trial for device effectiveness and safety endpoints. The assessment of pain relief and adverse events would typically follow pre-defined clinical protocols and criteria.

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

No, an MRMC comparative effectiveness study was not done. This study is a randomized controlled trial comparing the device's effectiveness (active stimulation) against a control (deactivated device) in patients.

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

Not applicable. The Freedom PNS System is a physical implanted medical device that requires human implantation and patient interaction (wearing an external transmitter) to function. Its "performance" is assessed through clinical outcomes in patients, not as a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth for effectiveness was established by patient-reported pain relief (at least 50% reduction compared to baseline). The ground truth for safety was established by the occurrence of serious adverse events.

8. The Sample Size for the Training Set

Not applicable. This is a clinical trial for device approval/expanded indication, not an AI/ML algorithm development where data sets are typically split into training and test sets in that manner. The described study is the clinical evidence used to support the device's efficacy and safety for its intended use.

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

Not applicable, as there isn't a "training set" in the context of an AI/ML algorithm. The clinical data from the trial serves as the evidence for the device's performance.

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The Neuspera Nuity™ System (NNS) 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 Neuspera Nuity™ System (NNS) is also used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) implant.

The Neuspera Nuity™ System is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The System consists of an implantable pulse generator (IPG), electrode array, surgical implant tools, wireless worn transmitter, clinician programmer, a patient controller, and undergarments. The implantable pulse generator is a miniature implanted neurostimulator, powered by an externally worn wireless transmitter device which contains a rechargeable battery.

Same as the predicate, the Neuspera Nuity™ System utilizes pulsed electrical current to create an energy field that acts on the targeted nerve to inhibit the transmission of pain signals to the brain. The Neuspera Nuity™ System may also be used during the trial period before recommendation for permanent implant.

The Neuspera Nuity™ System (NNS) is comprised of the following components: Neuspera Implanted Pulse Generator (IPG) Or Neuspera Implanted Microstimulator, Electrode Array, Surgical/Implant Tools, Externally Worn Wireless Transmitter, Clinician Programmer and Patient Controller.

The provided text does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any other quantifiable measure. Instead, the document is an FDA 510(k) clearance letter and summary, primarily focusing on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and safety aspects.

Therefore, many of the requested categories cannot be filled as they would relate to a clinical or performance study of the device's diagnostic or therapeutic effectiveness, which is not detailed in this document. The information provided is mainly related to bench testing, engineering comparisons, and biocompatibility.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria for performance metrics (e.g., pain reduction scores, successful stimulation rates) nor does it provide a clinical study to report on these. The closest information available is a comparison of technological characteristics to a predicate and reference device, implying that meeting or being comparable to these characteristics is a form of acceptance.

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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 Neuspera Neurostimulation System (NNS) 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 Neuspera Neurostimulation System (NNS) is also used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) implant.

The Neuspera Neurostimulation System is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The System consists of an implantable pulse generator (IPG), electrode array, surgical implant tools, wireless worn transmitter, clinician programmer and a patient controller. The implantable pulse generator is a miniature implanted neurostimulator, powered by an externally worn wireless transmitter device which contains a rechargeable battery.

The provided text is a 510(k) summary for the Neuspera Neurostimulation System (NNS). It details the device's indications for use, its components, and a comparison to predicate devices, focusing on technological characteristics. However, this document describes a neurostimulation system for pain management, NOT an AI/ML medical device for image analysis or diagnosis.

Therefore, the information required to answer your prompt, which is specifically related to acceptance criteria and studies for AI/ML device performance (e.g., accuracy, sensitivity, specificity, expert ground truth, MRMC studies), is not present in this 510(k) summary. The summary focuses on hardware specifications, electrical properties, biocompatibility, and animal studies for an implantable medical device, and explicitly states "Clinical evaluation is not required".

To directly address your request, if this were an AI/ML device submission, here's what the answer would look like (hypothetically, based on typical AI/ML medical device FDA submissions):

Hypothetical Response (if this were an AI/ML device, assuming typical FDA AI/ML study requirements):

This 510(k) summary does not appear to be for an AI/ML medical device that requires clinical performance studies based on human reader performance or algorithm-only metrics. The device, Neuspera Neurostimulation System (NNS), is an implanted peripheral nerve stimulator for pain relief. The provided documentation focuses on engineering specifications, biocompatibility, and non-clinical testing (functional, performance, MRI testing, animal studies) to demonstrate substantial equivalence to a predicate device.

The summary explicitly states: "Clinical evaluation is not required for the Neuspera Neurostimulation System as the indications for use are equivalent to the legally marketed predicate device and referenced device. These types of devices, including versions of the legally marketed predicate device, have been on the market for many years with a proven safety and efficacy for the use of the device. Therefore, Neuspera determined that bench and non-clinical testing are sufficient to demonstrate that the Neuspera Neurostimulation System is as safe and effective as the predicate device."

Therefore, the requested information regarding acceptance criteria, performance metrics (like sensitivity, specificity), data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, which are typical for AI/ML diagnostic or prognostic devices, is not applicable or available in this specific 510(k) submission for the Neuspera Neurostimulation System.

If this were an AI/ML device submission, the following sections would be populated (but cannot be from the provided text):

1. Table of acceptance criteria and reported device performance:
   (Hypothetical example for an AI/ML device)

2. Sample size used for the test set and the data provenance:
   (Hypothetical example for an AI/ML device)

   • Test Set Sample Size: E.g., 500 cases (e.g., medical images).
   • Data Provenance: Retrospective, collected from multiple institutions across the United States, Europe, and Asia.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   (Hypothetical example for an AI/ML device)

   • Number of Experts: E.g., 3 independent board-certified radiologists.
   • Qualifications: Each radiologist had a minimum of 10 years of experience specializing in (e.g., thoracic imaging) and were blinded to the device's output.

4. Adjudication method for the test set:
   (Hypothetical example for an AI/ML device)

   • Adjudication Method: 2+1; if two initial readers disagreed, a third senior expert (adjudicator) reviewed the case to establish the final ground truth.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
   (Hypothetical example for an AI/ML device)

   • MRMC Study: Yes, an MRMC study was conducted comparing human reader performance with and without AI assistance.
   • Effect Size: Human readers demonstrated a statistically significant improvement in diagnostic accuracy (e.g., 15% increase in AUC) when assisted by the AI device compared to unassisted reading. The sensitivity increased by X% and specificity by Y%.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   (Hypothetical example for an AI/ML device)

   • Standalone Performance: Yes, standalone performance was evaluated on the test set. The algorithm achieved a sensitivity of 92.5% and a specificity of 85.1%.

7. The type of ground truth used:
   (Hypothetical example for an AI/ML device)

   • Ground Truth Type: Expert consensus (from the expert radiologists) reviewed against relevant clinical outcomes data (e.g., biopsy results, surgical pathology, or patient follow-up data for disease progression/regression).

8. The sample size for the training set:
   (Hypothetical example for an AI/ML device)

   • Training Set Sample Size: E.g., 10,000 cases.

9. How the ground truth for the training set was established:
   (Hypothetical example for an AI/ML device)

   • Training Set Ground Truth: Established by a combination of clinical reports, a subset reviewed by a single board-certified radiologist, and confirmed with pathology results or long-term patient follow-up where available. Automated methods (e.g., natural language processing of reports) were also used for initial labeling, with a portion of cases undergoing expert review for quality control.

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Moventis PNS 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 Moventis PNS is not intended to treat pain in the craniofacial region.

Moventis PNSTM is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain originating from peripheral nerves. The therapy utilizes pulsed electrical waveforms to create an electrical energy field that acts on afflicted peripheral nerves to alter the transmission of pain signals from those nerves to the brain. Moventis PNS is comprised of percutaneous Implanted Pulse Generator (pIPG) and a preprogrammed External Transmitter (ETx) worn outside the body over the general area of the pIPG to provide signal and power.

This document (K200848) is a 510(k) premarket notification for the Moventis PNS, an implanted peripheral nerve stimulator for pain relief. The submission asserts substantial equivalence to predicate devices, meaning it has the same intended use and similar technological characteristics.

The information provided primarily focuses on non-clinical performance and substantial equivalence to legally marketed predicate devices, rather than a clinical study establishing acceptance criteria and device performance in a traditional sense. The device is cleared based on demonstrating compliance with recognized standards and equivalence to existing devices, not on a new clinical trial that sets and meets specific performance metrics for the Moventis PNS.

Therefore, many of the requested elements for a study that proves the device meets acceptance criteria are not directly applicable or explicitly stated as clinical performance data in this regulatory document. However, I can extract the relevant information regarding the device's technical specifications and the non-clinical testing performed to establish its safety and effectiveness relative to predicate devices and recognized standards.

Here's an analysis based on the provided document:

1. Table of acceptance criteria and the reported device performance.

The document does not present specific clinical acceptance criteria (e.g., target pain reduction percentages or success rates from a clinical trial) that the Moventis PNS had to meet. Instead, acceptance is based on demonstrating compliance with recognized safety and performance standards for medical devices and showing substantial equivalence to predicate devices. The "reported device performance" in this context refers to the outcomes of non-clinical testing.

• Passed cytotoxicity, sensitization, irritation, intracutaneous reactivity, acute systemic toxicity, genotoxicity, implantation (4, 8, 13 weeks), and subchronic toxicity tests.
• Materials (Pellethane 55D, Pt-Ir 90:10) have extensive record of chronic and carcinogenic safety.
• ETx is a non-contacting device.
• Meets biological safety and compatibility requirements. |
  | Electrical Safety (IEC 60601-1:2005 + A1:2012) | - ETx demonstrated compliance for electrical safety.
• pIPG prevents direct current density at electrodes above 0.75 uA/mm².
• Withstands dielectric strength testing.
• Meets electrical safety requirements. |
  | Electromagnetic Compatibility (EMC) & Wireless Coexistence (IEC 60601-1:2005 + A1:2012, IEC 60601-1-2:2014) | - ETx demonstrated compliance for electromagnetic interference and wireless coexistence.
• Moventis PNS met all acceptance criteria for emissions, low-frequency magnetic fields, immunity, electrostatic discharge, radiated RF electromagnetic fields, and magnetic fields. Operates within test limits with no physical damage and full operation.
• Meets EMC and wireless coexistence requirements. |
  | Usability (IEC 62366:2015) | - ETx demonstrated compliance, meeting acceptance criteria of usability validation plan and mitigating risks.
• Meets usability requirements. |
  | Risk Management (ISO 14971:2019) | - Risks associated with wireless communication mitigated through risk analysis, evaluation, control, and safety by design.
• Product labeling indicates medical procedures contraindicated for use.
• Gradual, long-term material changes do not result in unacceptable risks.
• Risks mitigated as far as possible. |
  | Packaging (ISO 11607-1) | - Verified to protect devices from shock, stacking, vibration, temperature, pressure, and humidity variations.
• Complies with packaging requirements. |
  | Markings (Durability and Legibility Requirements) | - Demonstrates compliance with durability and legibility requirements.
• All requirements and markings clearly identified and viewable.
• Complies with marking requirements. |
  | Sterilization (ISO 14708-3:2017 in compliance with ISO 11135:2014) | - Validated for ethylene oxide (EO) sterilization.
• Verified no unacceptable release of particulate matter at implantation.
• Meets sterilization requirements. |
  | Heating Limits | - Does not exceed heating limits.
• Protects patients from heating harm. |
  | External Influences (Defibrillation, Ultrasound, EMF) | - Demonstrated safe operation in presence of external defibrillation, ultrasound, and electromagnetic fields.
• No irreversible damage following exposure to changes in electric fields.
• pIPG functional after exposure to external defibrillation.
• Demonstrates safety under external influences. |
  | Mechanical Force Test (IEC 60601-1:2005 + A1:2012) | - Passed free-fall tests. No visible damage or functional damage.
• Mechanical testing (tensile, flex, torsion) showed pIPGs comply with mechanical design requirements.
• Meets mechanical force test criteria. |
  | Electrostatic Discharge (ESD) (IEC 60601-1:2005 + A1:2012 and IEC 60601-1-2:2014) | - Demonstrated safe operation following ESD.
• Protects from ESD damage. |
  | Atmospheric Pressure & Temperature Test (IEC 60601-1) | - No change to device specification or damage following exposure to absolute pressure or changes in temperature (including shipping/storage ranges).
• Meets atmospheric pressure and temperature test criteria. |
  | Ingress of Water (IEC 60529) | - Met visual and functional inspection passing criteria. No physical damage, fully operational.
• Satisfies ingress of water requirements. |
  | Particulate Matter (IEC 60529) | - Met visual and functional inspection passing criteria. No physical damage, fully operational.
• Satisfies particulate matter requirements. |
  | Means of Protection, Creepage Distances, Air Clearances (IEC 60601-1) | - Design analysis confirmed system satisfies requirements.
• Complies with protection requirements. |

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

The document refers to non-clinical testing rather than a "test set" of patient data. For non-clinical performance and safety testing (e.g., electrical safety, biocompatibility, mechanical testing), the sample sizes are not explicitly stated for each test but would typically involve a sufficient number of units to demonstrate compliance with the relevant standards.

• Sample Size: Not explicitly stated for each non-clinical test, but implied to be sufficient for compliance with each standard.
• Data Provenance: All testing appears to be prospective bench and lab testing conducted by the manufacturer (Micron Medical Corporation) or contracted labs to demonstrate compliance with design requirements and international standards. No patient data (retrospective or prospective) is described as being used for performance evaluation in this 510(k).

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

This question is not applicable. No clinical "test set" requiring expert-established ground truth was used for this 510(k) submission. The evaluation focused on non-clinical performance and comparison to predicate devices, which relies on engineering and scientific expertise relevant to the standards.

4. Adjudication method for the test set.

This question is not applicable. No clinical "test set" and thus no adjudication method were described.

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.

This question is not applicable. The device is a physical medical device (peripheral nerve stimulator), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned.

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

This question is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used.

For the non-clinical testing, the "ground truth" refers to the established requirements and specifications defined by international standards (e.g., ISO, IEC) and the device's own design inputs. The device's performance was measured against these predefined thresholds and compliance criteria, not against clinical outcomes or expert consensus on patient data.

8. The sample size for the training set.

This question is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This question is not applicable, as there was no "training set."

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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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