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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 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 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).
• 8. Optional Foot Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
• 9. Optional Mobile Application (MAPP), based on the SmartPhone platform enabling the patients to wirelessly retrieve and monitor their daily activity. At the time of clearance of K162407, the MAPP did not include any control feature, but control features like those of the Optional Control Unit have been added to the MAPP and are part of this submission.

This document is a 510(k) summary for the Bioness L300 Go System, focusing on modifications made to a previously cleared device (K162407). It does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria in terms of clinical effectiveness. Instead, it describes non-clinical testing performed to demonstrate that the modifications to the device do not alter its substantial equivalence to the predicate device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria for clinical performance or reported device performance in terms of efficacy metrics (e.g., gait improvement percentages, dorsiflexion angles). It focuses on non-clinical testing to ensure that modifications to the device (e.g., changes in material, software updates) do not negatively impact its safety and functionality compared to the predicate device.

For the non-clinical tests mentioned, the "acceptance criteria" can be inferred as "successfully passed the testing," indicating that the device's performance post-modification remained within acceptable limits for the specific tests conducted.

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

The document describes non-clinical engineering and software testing. It does not refer to a "test set" in the context of clinical data or patient samples.

• Sample Size for non-clinical tests: Not explicitly stated as a number of units, but common for such tests to involve one or a small number of physical units for destructive or environmental testing.
• Data Provenance: The testing was conducted internally by Bioness or by Minnetronix Inc. (a Bioness development vendor), indicating it is internal, likely prospective, engineering bench testing. There is no mention of country of origin regarding clinical data.

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

This information is not applicable. The document describes non-clinical hardware and software testing, not clinical studies requiring expert ground truth for patient outcomes.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (e.g., 2+1) are typically used in clinical studies for interpreting ambiguous results or establishing ground truth from expert readings. The tests described are engineering and software tests with defined pass/fail criteria.

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

No MRMC study was conducted or is mentioned in this document. The submission focuses on demonstrating substantial equivalence for minor device modifications and software upgrades through non-clinical testing, not on clinical effectiveness studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This concept is less applicable to a functional neuromuscular stimulator that inherently requires human interaction and application by a clinician/user. The document describes software verification and validation, including for the Mobile Application (MAPP) which has user interaction, but not a "standalone algorithm" performance in the sense of an AI diagnostic tool.

7. Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is typically defined by engineering specifications, validated test methods, and industry standards (e.g., ASTM standards for packaging, internal design requirements for software functionality). Not pathology, outcomes data, or expert consensus in a clinical sense.

8. Sample Size for the Training Set:

This information is not applicable. The text describes verification and validation of modified hardware and software, not the development of a machine learning model that would require a "training set."

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

This information is not applicable, as there is no "training set" for a machine learning model mentioned.

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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.

Not Found

This FDA Premarket Notification (510(k)) K142432 for the StimRouter Neuromodulation System does not contain the detailed clinical study information requested.

Here's why and what's missing:

1. Nature of the Document: This is a 510(k) clearance letter. It states that the device is "substantially equivalent" to legally marketed predicate devices. This regulatory pathway typically relies heavily on demonstrating similarity to existing devices through design, materials, and often, non-clinical (bench and animal) testing, rather than extensive new human clinical trials to prove efficacy against specific acceptance criteria in the same way a PMA (Pre-Market Approval) would.

2. Focus of the Letter: The letter focuses on the FDA's regulatory decision and administrative details (registration, labeling, reporting, etc.). It does not include the detailed study report or clinical data that the manufacturer would have submitted.

Therefore, I cannot extract the following information from the provided text:

• 1. A table of acceptance criteria and the reported device performance: This information would be in a clinical study report, which is not present here.
• 2. Sample sized used for the test set and the data provenance: Not available in this document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
• 4. Adjudication method for the test set: Not available.
• 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 device is a neuromodulation system for pain, not an AI-powered diagnostic imaging tool. Thus, an MRMC study is not relevant and certainly not included.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Again, this is a directly implantable neuromodulation device, not an AI algorithm.
• 7. The type of ground truth used: Not applicable in the context of demonstrating substantial equivalence for a neuromodulation device in a 510(k). The "ground truth" would be the clinical outcome (pain reduction), but the document does not detail studies proving this with specific criteria.
• 8. The sample size for the training set: Not applicable as this is not an AI/machine learning device that uses training sets in the conventional sense.
• 9. How the ground truth for the training set was established: Not applicable.

What is available from the document:

• Device Name: StimRouter Neuromodulation System
• Indications for Use: 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). Not intended to treat pain in the craniofacial region.
• Regulatory Class: Class II
• Product Code: GZF

To find the kind of detailed study information you're asking for, you would generally need to look for a clinical study report (CSR), a publication in a peer-reviewed journal, or a more detailed FDA document like a PMA review memo, which contains more in-depth data for devices requiring higher evidence. A 510(k) clearance letter itself does not provide this level of detail.

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The NESS H200® Wireless Hand Rehabilitation System is an electrical stimulation device indicated for the following uses:

Functional Electrical Stimulation (FES):

• Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury
  NeuroMuscular Electrical Stimulation (NMES):
• Maintenance and/or increase of range of motion -
• Prevention and/or retardation of disuse atrophy l
• Increase of local blood circulation -
• Reduction of muscle spasm —
• Muscle re-education |

The Intelli-Connect is an optional accessory device used exclusively with the H200 Wireless System. The Intelli-Connect is used to trigger the H200 Wireless Orthosis through simple jaw movements.

The NESS H200 System consists of the following components:

• Functional Stimulation (FS) Orthosis with a Radio Frequency (RF) Stim Unit .
• Control Unit .
• . Intelli-Connect triggering device optional accessory, consisting of an earpiece, a charger and connecting cable

The Intelli-Connect Earpiece triggering device is fitted over the ear and detects clicks of the teeth to wirelessly trigger the stimulation unit of the H200 Wireless orthosis. Software built into the Intelli-Connect earpiece is designed to register and work exclusively with the patient's orthosis. The Earpiece is rechargeable with a lithium-polymer battery. It is FCC identified and meets part 15 of the FCC regulations. Once the earpiece is turned on, Intelli-Connect will trigger stimulation when teeth are clicked together.

The provided document is a 510(k) Summary for the Bioness NESS H200 Wireless Hand Rehabilitation System with an optional Intelli-Connect Earpiece Triggering Device. It details various performance tests conducted to demonstrate the device's compliance and substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document does not specify the sample size for the test sets used in any of the performance verification tests (e.g., how many units were tested for electrical safety, EMC, battery, software, or user specifications). The provenance of the data (country of origin, retrospective or prospective) is also not mentioned. These tests appear to be bench or engineering tests rather than clinical studies with human participants.

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. The tests described are engineering and safety standard compliance tests, not clinical performance evaluations that would typically involve expert-established ground truth.

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

The document does not describe any adjudication method for the test sets. Given the nature of the tests (compliance with standards), adjudication by multiple experts is not typically applicable.

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

An MRMC comparative effectiveness study was not done. The device is a physical rehabilitation system accessory (a hands-free trigger), not an AI-assisted diagnostic or interpretive tool that would involve "human readers" or AI assistance in that sense.

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

This concept is not directly applicable to the Intelli-Connect earpiece. The Intelli-Connect is designed to work in conjunction with the H200 Wireless System to trigger functional stimulation based on jaw movements (teeth clicks). Its standalone performance relates to its ability to reliably detect these clicks and wirelessly transmit the trigger command, which is covered by the mentioned software and user specification verification tests. There isn't an "algorithm only" performance that would be separate from its intended human-in-the-loop use (as a trigger for a patient's rehabilitation).

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

For the engineering and safety tests, the "ground truth" is defined by the technical specifications and requirements of the referenced standards (e.g., IEC 60601-1, FCC Part 15, IEC 62133, ISO 10993) and the user specifications defined by the manufacturer. These are objective engineering criteria rather than clinical ground truth established by experts or pathology.

8. The sample size for the training set

The document does not mention any training set. This is a medical device accessory and its performance is validated through engineering, regulatory, and user specification testing, not typically through machine learning model training.

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

Not applicable, as there is no mention of a training set.

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The NESS L300 Foot Drop System is intended to provide ankle dorsiflexion in individuals (adults and pediatrics) who have foot drop following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot. The NESS L300 may improve gait, facilitate muscle re-education, prevent or retard disuse atrophy, maintain or increase joint range of motion, and increase local blood flow.

The L300 Foot Drop System consists of Control Unit and Intelli-Sense Gait Sensor.

I'm sorry, but this document does not contain the information requested regarding acceptance criteria and studies proving the device meets those criteria. The provided text is a 510(k) Summary and an FDA clearance letter for the Bioness L300 Foot Drop System, focusing on its substantial equivalence to predicate devices and expanded indications for use. It outlines the device description, indications for use, and regulatory information, but does not detail specific performance acceptance criteria or the results of a study designed to demonstrate them.

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