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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 L100 Go System is intended to provide ankle dorsiflexion in adults with foot drop or muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to the spinal cord). The L100 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot; thus, it also may improve the adult's gait.

The L100 Go System may also:

• · Facilitate muscle re-education
• · Prevent/retard disuse atrophy
• · Maintain or increase joint range of motion
• · Increase local blood flow

The L100 Go System is designed to improve gait in adults suffering from foot drop or muscle weakness. The L100 Go System can also deliver transcutaneous stimulation to the muscles in the lower leg to facilitate muscle re-education, prevent/retard disuse atrophy, maintain or increase joint range of motion, and/or increase local blood flow.

The L100 Go system consists of the following L300 Go components/accessories with the exception of a modified lower leg cuff:

• 1. External Pulse Generator (EPG), which can be plugged into Lower Leg Cuff. EPG contains user interface including control and indications. EPG also contains integrated motion sensors enabling detecting gait events.
• 2. Lower Leg Cuff, including cradle for the EPG. This is the only L300 Go component modified for the L100 Go.
• 3. Clinician Application (CAPP), installed on tablet PC. CAPP is used by a trained clinician during configuration of the system for optimal fitting to the patient.
• 4. Power supply (charger) with two USB ports and a proprietary cable to charge the EPG.
• 5. Tester, which is used for trouble shooting to confirm that stimulation is being delivered.
• 6. Optional Mobile Application (MAPP), based on the iOS and Android SmartPhone platform enabling the patients to wirelessly control the EPG(s) and retrieve and monitor their daily activity.
• 7. Electrode and electrode bases which are attached to the inner side of the lower leg cuff.

The L100 Go System can be operated in one of the following modes:

• Gait Mode
• Training Mode •
• . Clinician Mode

Gait Mode is used for walking, and it can be selected by the clinician and also by the patient. Training Mode is used to train muscles when patients are not walking (for example, sitting or lying down), and it can be selected by either the clinician or the patient. Clinician Mode allows the clinician to apply enhanced training and is only available to the clinicians.

This document is a 510(k) Pre-market Notification for a modified medical device, the L100 Go System. The submission claims substantial equivalence to a legally marketed predicate device, the L300 Go System.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes modifications to a pre-existing medical device, the L300 Go System, resulting in the L100 Go System. The acceptance criteria are implicit in the claim of "substantial equivalence" to the predicate device and the successful completion of "verification testing" for the modified components. Since this is a Special 510(k) for device modifications, specific performance metrics are not explicitly presented as acceptance criteria and reported performance in a table format. Instead, the document focuses on demonstrating that the changes do not negatively impact the safety and effectiveness, and that the modified components meet their design specifications.

The provided text states:

• "The modified cuff design was subjected to verification testing to ensure no loss of mechanical strength and functionality."
• "The L100 Go System has been verified and validated successfully for its intended use through the combination of predicate device bench testing and thorough verification and validation testing of all changes."
• "Based on the result of the nonclinical testing, Bioness concludes that the device is substantially equivalent to the predicate L300 Go System."

This indicates that the acceptance criteria were that the modified cuff design would show no loss of mechanical strength and functionality compared to the predicate device, and that all changes would pass verification and validation testing to confirm safety and effectiveness for its intended use.

The reported device performance is that these tests were "successfully" completed, affirming that the L100 Go System maintains substantial equivalence to the L300 Go System despite the modifications.

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

The document describes "nonclinical tests" and "verification and validation testing of all changes." However, it does not specify the sample size used for these tests. The data provenance is also not explicitly stated beyond being "nonclinical testing" performed by the manufacturer (Bioness Inc.). It is implied to be laboratory/bench testing rather than clinical data.

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

This information is not provided in the document. As the testing focuses on mechanical strength and functionality of hardware modifications, the "ground truth" would likely be established by engineering and quality control experts within Bioness, following established testing protocols, rather than medical experts for clinical performance.

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

This information is not provided. As it's nonclinical verification testing, formal adjudication methods by external experts, as seen in clinical studies, are typically not applicable. The results would be assessed against pre-defined engineering and performance specifications.

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 is not applicable. The device (L100 Go System) is an external functional neuromuscular stimulator for foot drop, not an AI-powered diagnostic or assistive technology for human "readers." Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers would not be relevant to this submission.

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

This is not applicable. The L100 Go System is a physical medical device (an external functional neuromuscular stimulator), not an algorithm or software-only device. Its performance inherently involves the device interacting with a patient's body under clinician or patient control.

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

For the "nonclinical tests" related to the modified cuff design, the ground truth would be based on engineering specifications and established performance standards for mechanical strength and functionality. This would involve objective measurements (e.g., tensile strength, durability, electrical output parameters) compared against pre-defined thresholds derived from the predicate device and relevant industry standards (e.g., IEC 60601 series).

8. The sample size for the training set:

This is not applicable. The L100 Go System is a modified physical medical device, not a machine learning model that requires a training set.

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

This is not applicable, as there is no training set for this type of 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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The L360 Thigh System is intended to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual's gait.

The L360 Thigh System may also:

• Facilitate muscle re-education
• Prevent/retard disuse atrophy
• Maintain or increase joint range of motion
• Increase local blood flow
• Provide early post-surgical quadricep and hamstring strengthening
• Improve post-surgical knee stability secondary to quadricep and hamstring strengthening
• Relax muscle spasms

The L360 Thigh System is intended to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damaqe to pathways to the spinal cord). The L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual's gait.

The L360 Thigh System consists of:

• 1. One or two Thigh Functional Stimulation Cuffs (Thigh Cuff) that include surface electrodes.
• 2. Central External Pulse Generator (EPG). The EPG delivers stimulation to their respective cuffs, and have user interface, including visual, audio, and tactile feedback. The EPG can use motion sensor based algorithm to detect heel events.
• 3. An optional Control Unit that allows simple wireless remote control of the EPG's while displaying real-time information regarding the system's status.
• 4. An optional Gait Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
• 5. A Clinician's Programming System with software, which is used for system programming by a trained clinician during configuration of the system for optimal fitting to the patient.
• 6. An optional Mobile Application (MAPP) enabling the patients to wirelessly control the EPG(s) and retrieve and monitor their daily activity.
• 7. A power supply with two USB outputs and a proprietary cable to charge the EPG(s).

This document is a 510(k) Premarket Notification for the Bioness L360 Thigh System, seeking to expand its indications for use. Based on the provided text, the acceptance criteria are primarily demonstrated through a showing of substantial equivalence to existing predicate devices, rather than through a a new clinical study with explicitly defined performance metrics the device needs to meet.

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

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

The document does not provide a traditional table of acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity, or improvement in a clinical outcome that the device must achieve).

Instead, the acceptance criteria for this 510(k) submission are based on demonstrating substantial equivalence to two predicate devices: the Bioness L300 Go System (K190285) and the Bio-Medical Research Ltd. Kneehab XP (K110350). The performance reported is that the device "is performing as intended" and "is substantially equivalent to the predicate devices."

The submission argues that the L360 Thigh System is essentially the "Thigh Standalone configuration" of the L300 Go System, with the only difference being an expansion of indications. Therefore, the performance tests conducted on the L300 Go System are considered applicable.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective).

The document does not describe a new clinical "test set" in the context of typical AI/ML performance evaluation (e.g., a set of patient cases used to evaluate an algorithm's diagnostic accuracy). Instead, it refers to performance tests (electrical, mechanical, functional, software V&V, EMC, biocompatibility) conducted on the L300 Go System (the predicate device). These are engineering and system-level tests, not typically clinical trials involving patient samples.

• Sample Size for Test Set: Not applicable in the context of patient data samples for algorithm performance. The "test set" refers to the device itself being subjected to various engineering and regulatory conformance tests.
• Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable for the type of testing described. The "data" here are results from engineering and biocompatibility tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience).

This question is not applicable to the type of device and submission described. This is a functional neuromuscular stimulator, not an AI/ML diagnostic or image analysis device that requires expert ground truth labeling for a test set. The validation relies on engineering and biological safety tests, and a showing of substantial equivalence to predicate devices, supported by scientific literature on the principle of NMES.

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

Not applicable. There is no clinical test set requiring expert adjudication for ground truth, as this is not an AI/ML diagnostic device.

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 submission is for a functional electrical stimulation device, not an AI-assisted diagnostic or image interpretation tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not relevant to this device or its regulatory pathway.

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

Not applicable. While the device has software and algorithms for stimulus delivery and gait detection, it is a hardware medical device with specific physical and electrical outputs for therapeutic purposes. Its "performance" is in stimulating muscles as intended, not in autonomously interpreting data or making diagnostic decisions without human involvement in setting up or managing the therapy. The performance tests mentioned (functional, software V&V) implicitly cover standalone algorithm functioning within the device.

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

For the specific type of device and submission (510(k) for an expanded indication based on substantial equivalence), "ground truth" as typically understood in AI/ML validation (e.g., definitive diagnosis) is not explicitly mentioned or relied upon. The ground truth for proving substantial equivalence relies on:

• Technical Specifications Comparison: Direct comparison of electrical, mechanical, and software characteristics to predicates.
• Engineering Test Results: Pass/fail criteria for electrical safety, EMC, reliability, etc., as per recognized standards (e.g., IEC 60601 series, ISO 14971, ISO 10993).
• Prior Regulatory Clearances: The fact that the predicate devices were previously cleared by the FDA establishes their safety and effectiveness characteristics as a benchmark.
• Scientific Literature and Principle of NMES: Supporting the general safety and effectiveness of Neuromuscular Electrical Stimulation for the stated indications.

8. The sample size for the training set.

Not applicable. This document describes a traditional medical device, not an AI/ML product developed using large training datasets. The "training" for such devices typically refers to the engineering design and development process, informed by established medical principles and device standards.

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

Not applicable. As above, there is no AI/ML training set as such. The "ground truth" for the device's design and functionality comes from established engineering principles, international standards, and existing regulatory clearances of similar predicate devices.

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The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g. stroke, damage to pathways to the spinal cord). The L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension: thus, it also may improve the individual's gait.

The L300 Go System may also:

• o Facilitate muscle re-education
• o Prevent/retard disuse atrophy
• o Maintain or increase joint range of motion
  o Increase local blood flow

The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait.

The L300 Go system consists of the following components:

• 1. External Pulse Generator (EPG), which can be plugged into lower leg Functional Stimulation Cuff (FSC) or thigh FSC or into both cuffs. EPG contain user interface including control and indications. EPG also contains integrated motion sensors enabling detecting gait events.
• 2. Lower leg FSC, including cradle for the EPG.
• 3. Upper leg FSC, including cradle for the EPG.
• 4. Clinician Application (CAPP), based on tablet PC. CAPP will be used by a trained clinician during configuration of the system for optimal fitting to the patient.
• 5. Power supply (charger) with two USB ports and a proprietary cable to charge the EPG.
• 6. L300 Go Tester.
• 7. Optional Control Unit that allows simple control of the EPG(s) such as selecting mode of operation (gait/training) or fine-tune the stimulation intensity for each EPG individually.
• 8. Optional Foot Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
• 9. Optional Mobile Application (MAPP), which can be downloaded on a smartphone and offers the same control functions as the optional Control Unit, as well as enabling the patients to retrieve and monitor their daily activity. At the time of clearance of K173682, the MAPP was only an iOS-based application. In this submission, Bioness is adding an Android-based MAPP. The software features, user interface, and wireless communication protocol of the Android version are the same as the iOS version, the only difference is the operating system.

The L300 Go System can be operated in one of the following modes:

• Gait Mode
• Training Mode ●
• . Cycle Training Mode
• . Clinician Mode

Gait Mode is used for walking, and it can be selected by the clinician and also by the patient. Training Mode is used to train muscles when patients are not walking (for example, sitting or lying down), and it can be selected by either the clinician or the patient. Cycle Training Mode is used to train muscles while the patient is using a stationary exercise bicycle, and it can be selected by either the clinician or the patient. Clinician Mode allows the clinician to apply enhanced training and is only available to the clinicians.

The provided text describes a Special 510(k) submission for the Bioness L300 Go System, primarily focused on device modifications including software changes and the addition of an Android version Mobile Application. The submission asserts that these changes do not affect the intended use or fundamental scientific technology of the device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a quantitative table for this specific Special 510(k) submission. Instead, the submission focuses on demonstrating that the modified device maintains the safety and efficacy previously established for its predicate device (K173682) through verification and validation testing of the changes.

The reported device performance, in this context, refers to the successful completion of these tests:

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

The document does not specify sample sizes used for the "verification testing" or "validation testing" mentioned for software/firmware/cyclic training mode. It also does not provide information on the provenance of data (e.g., country of origin, retrospective/prospective). These details would typically be found in more comprehensive study reports, which are not included in this FDA 510(k) summary.

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

This document does not describe any study involving human experts establishing ground truth for a test set. The testing described appears to be engineering or performance testing against predefined technical specifications and standards.

4. Adjudication Method for the Test Set

Not applicable, as there's no mention of a ground truth established by human experts or a test set requiring adjudication in the context of this document. The testing described is primarily technical verification and validation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned in this document. The device is a functional neuromuscular stimulator, not an imaging or diagnostic AI tool that would typically involve human readers interpreting cases.

6. Standalone (Algorithm Only) Performance Study

While the document describes rigorous testing of the device's software and hardware (including the algorithms within the EPG and mobile applications), it doesn't present this as a "standalone" performance study in the context of a comparative effectiveness study against a human baseline or a widely accepted clinical standard for an AI diagnostic algorithm. The aim here is to confirm the device's functional integrity after modifications.

7. Type of Ground Truth Used

The "ground truth" for the tests described appears to be:

• Technical Specifications and Requirements: For software/firmware functionality and the cyclic training mode.
• Industry Standards: For environmental ingress protection (IP42) and transportation testing.
• Predicate Device Performance: The primary "ground truth" is that the modified device should perform equally safely and effectively as the previously cleared predicate device (K173682).

8. Sample Size for the Training Set

The document does not describe any "training set" in the context of machine learning or AI models being trained. The "software and firmware changes" likely refer to updates in control logic, user interface, or functional modes, which are verified and validated rather than trained on data.

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

Not applicable, as no training set for an AI model is mentioned or implied.

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The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the flexion or extension: thus, it also may improve the individual's gait.

The L300 Go System may also:

• Facilitate muscle re-education
• · Prevent/retard disuse atrophy
• · Maintain or increase joint range of motion
• · Increase local blood flow

The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, spinal cord injury) or other disability. The L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's qait.

The L300 Go System consists of:

• 1. One or two Functional Stimulation Cuffs (L300 Lower Leg and Thigh), that include surface electrodes.
• 2. External Pulse Generator (EPG) for the lower leg and EPG for thigh. Both EPG's deliver stimulation to their respective cuffs, and have user interface, including visual, audio, and tactile feedback. Lower EPG can use motion sensor based algorithm to detect heel events.
• 3. A Control Unit that allows simple wireless remote control of the EPG's while displaying real-time information regarding the system's status.
• 4. An optional Gait Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
• 5. A Clinician's Programming System with software, which is used for system programming by a trained clinician during configuration of the system for optimal fitting to the patient.
• 6. A power supply with two USB outputs and a proprietary cable to charge the EPG.

This document is a 510(k) Summary for the Bioness L300 Go System, a medical device intended to provide ankle dorsiflexion and/or assist knee flexion/extension. The primary purpose of this document is to demonstrate substantial equivalence to previously cleared predicate devices, not to present a comprehensive study proving device performance against acceptance criteria. Therefore, most of the requested information regarding study details, sample sizes, expert involvement, and ground truth establishment is not available in the provided text.

Based on the available information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the L300 Go System in terms of performance metrics like accuracy, sensitivity, or specificity. Instead, it demonstrates an equivalence to predicate devices in various technical specifications and functional aspects. The tables (Table 1.0, Table 2a, Table 2b) primarily compare the technical output specifications and basic unit characteristics of the L300 Go System with its predicate devices.

The document asserts that the L300 Go System "does not introduce any new issues of safety or efficacy" relative to its predicate devices, implying that its performance is equivalent in these aspects.

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

Not provided. The document outlines a substantial equivalence argument rather than a dedicated performance study with a test set.

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

Not provided. There is no mention of a test set or ground truth established by experts.

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

Not provided. There is no mention of an adjudication method.

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 device is an external functional neuromuscular stimulator, not an AI-assisted diagnostic or imaging device that would typically involve human "readers" or an MRMC study.

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

This question generally applies to AI-driven diagnostic systems. The L300 Go System includes algorithms (e.g., motion sensor-based algorithm to detect heel events, dynamic gait tracking algorithm), but the device itself is a functional electrical stimulator, not an algorithm-only device. Its functionality inherently involves interaction with the human body to achieve a therapeutic effect. The document focuses on the technical specifications and equivalency to previously cleared devices.

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

Not provided. The document focuses on technical specifications and functional equivalence rather than clinical ground truth for a diagnostic outcome.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that would be "trained" in the traditional sense on a dataset. The document discusses "software" and "firmware" but not a machine learning training process.

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

Not applicable. See point 8.

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The NESS L300 Plus System is intended to provide ankle dorsiflexion and knee flexion or extension in individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury or disease. During gait the L300 Plus System electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot and knee flexion or extension, thus it may improve the individual's gait. The L300 Plus System may also:

• Facilitate Muscle re-education
• Prevent/retard disuse atrophy
• Maintain or increase joint range of motion
• Increase local blood flow

The NESS L300 Plus System is intended to provide ankle dorsiflexion and knee flexion or extension in individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury or disease. The NESS L300 Plus System is a combination of its two predicate devices of its two predicate devices, the NESS L300 (K080219) and the NESS System (K022776).
The NESS L300 Plus System consists of:

• A Control Unit that allows simple operation while displaying real time information regarding the system's status.
• Two Functional Stimulation Cuffs (L300 and Thigh, figures 11-2, 11-3 respectively), that include two surface electrodes and an integrated configurable Radio Frequency Stimulation unit each.
• A Gait Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
• A Clinician's Programming System with software, which is used for system programming by a trained clinician during configuration of the system for optimal fitting to the patient.
• A L300 Tester. The L300 Tester is utilized for checking the RFSs and FSCs for functionality.
• A power supply with a 3-way splitter cable to charge the Control Unit and both Radio Frequency Stimulation units.

This 510(k) summary for the NESS L300 Plus System does not contain the specific information requested regarding acceptance criteria, study details, or performance data.

Here's what is available from the document:

• Device Name: NESS L300 Plus System
• Intended Use Statement: "The NESS L300 Plus System is intended to provide ankle dorsiflexion and knee flexion or extension in individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury or disease. During gait, the L300 Plus System electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot and knee flexion or extension, thus it may improve the individual's gait. The L300 Plus System may also: facilitate muscle re-education, prevent/retard disuse atrophy, maintain or increase joint range of motion, and increase local blood flow."
• Predicate Devices: NESS L300 (K080219) and NESS system (K022776).
• Purpose of 510(k): "The NESS L300 Plus is a new device based on the NESS L300 and on the NESS system." It is a combination of these two predicate devices.
• Conclusion: Bioness Neuromodulation believes the NESS L300 Plus is substantially equivalent to its predicate devices "without raising any new safety and effectiveness concerns."

Missing Information:

The document focuses on establishing substantial equivalence to predicate devices, which is common for 510(k) submissions. It does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, data provenance, or details of a study proving the device meets acceptance criteria.
3. Number of experts, their qualifications, or adjudication methods for ground truth establishment.
4. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes.
5. Details of a standalone algorithm performance study.
6. The type of ground truth used (e.g., pathology, outcomes data).
7. Sample size for a training set.
8. How ground truth for a training set was established.

This is a substantial equivalence (510(k)) submission, which typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical trials to establish de novo performance criteria against specific acceptance thresholds. Therefore, the details requested for a study proving the device meets defined acceptance criteria are not present in this type of submission.

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