(140 days)
The Cionic Neural Sleeve NS-200 is intended to provide ankle dorsiflexion and/or plantarflexion and/or eversion in adult 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 Cionic Neural Sleeve NS-200 electrically stimulates muscles in the affected leg to provide ankle dorsiflexion and/or plantarflexion and/or eversion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait.
The Cionic Neural Sleeve NS-200 may also:
- Facilitate muscle re-education
- Prevent/retard disuse atrophy
- Maintain or increase joint range of motion
- Increase local blood flow
As a powered muscle stimulator the Cionic Neural Sleeve NS-200 is indicated for the following conditions:
- Relaxation of muscle spasm
As a biofeedback device the Cionic Neural Sleeve NS-200 is indicated for the following conditions:
- Biofeedback, relaxation and muscle re-education purposes
Same as the primary predicate device, the Cionic Neural Sleeve NS-100 (K221823), the Cionic Neural Sleeve NS-200 is a platform for the measurement and augmentation of lower limb mobility composed of a body-worn legging, a battery-powered electronic controller and a mobile application. The Cionic Neural Sleeve NS-200 has embedded sensors to measure limb movement and muscle activity. These data are used by the control unit to generate stimulation intended to activate muscles for exercise or functional assistance.
The Cionic Neural Sleeve NS-200 system sales carton consists of the following components:
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SL-200 a fabric sleeve covering the upper and lower leg containing embedded motion sensors and skin-contacting electrodes. Left and right leg sleeves are available in four sizes: extra-small, small, medium, and large.
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DC-200 a portable battery-powered Control and Stimulation Unit that connects to, and is worn within the SL-200. The DC-200 communicates over Bluetooth™Low Energy protocol to the Cionic mobile application ("Cionic app").
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Power supply and cable to recharge the DC-200 and connect the DC-200 to a user's computer when required.
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Adhesive, electrically conductive and replaceable electrode pads.
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Electrode cover sheets.
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Instructions for Use documents.
Components are available as accessories to the Cionic Neural Sleeve NS-200 system:
- Replacement electrode pads.
The Cionic Neural Sleeve NS-200 requires a password-protected Cionic mobile application that is exclusively available to Cionic Neural Sleeve NS-200 iOS and Android users.
The Cionic Neural Sleeve NS-200 system consists of a software and hardware architecture that enables users to access a library exercise and programs. Programs can be added and removed from the user's mobile app by the user. All exercise and assistance programs utilize a standard calibration and stimulation user interface that is extendible to future exercise and augmentation programs.
The following minor hardware/mechanical changes have been made to the NS-100 (K221823) and incorporate in the NS-200:
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Simplified Sleeve Electronics
By relocating the electromyography (EMG) circuitry to the Control Unit (DC-200), the redesigned Sleeve (SL-200) is now lighter, more streamlined, and requires less power—delivering a more comfortable and efficient experience for users. -
Enhanced Control Unit Grip
The Control Unit (DC-200) now features integrated side grips, making it easier to connect and disconnect from the sleeve cable—while maintaining the same compact form factor users love. -
More Secure Fit, All Day Comfort
Enhanced Velcro sections on the Sleeve (SL-200) offer improved adherence and a more secure fit, supporting confident wear and optimal electrode positioning throughout the day.
The provided text is a 510(k) clearance letter and summary for the Cionic Neural Sleeve NS-200. It describes the device's technical characteristics and its substantial equivalence to predicate devices. However, the document does NOT contain information about acceptance criteria or specific study results that prove the device meets performance criteria, especially concerning the new functionality of advanced biofeedback within the NS-200.
The document states:
- "The tests listed have been conducted to demonstrate that the Cionic Neural Sleeve NS-200 performs as intended and is substantially equivalent to both predicate devices."
- "The Cionic Neural Sleeve NS-200 has been verified and validated successfully for its intended use through a combination of original bench testing and verification and validation of all software and firmware."
This indicates that testing was done, but the details of the acceptance criteria, specific performance metrics, and the results of those tests are not included in this publicly available clearance letter. For example, while it mentions "Stimulation Output Waveforms" and "Stimulation Output Specifications" as tests conducted, it doesn't provide the target waveform characteristics (acceptance criteria) or the measured waveform characteristics (reported performance).
Similarly, for the "New Functionality in NS-200" related to biofeedback (Visual Biofeedback Mode and Muscle Activated Stimulation Mode), the document describes how it works but doesn't provide any quantitative acceptance criteria for its performance (e.g., accuracy of sEMG detection, latency of stimulation trigger).
Therefore, based solely on the provided text, I cannot fulfill most of your request for specific acceptance criteria and study results. The information is simply not present in this type of FDA document, which focuses on substantial equivalence for market clearance rather than detailed performance study reporting.
However, I can extract and infer some high-level information and point out what is missing:
Inferred/Missing Information based on the Provided Text:
Based on the nature of a 510(k) clearance and the information provided, the "acceptance criteria" here are implicitly tied to demonstrating substantial equivalence to predicate devices and meeting relevant safety and performance standards. The "study" mentioned is primarily focused on non-clinical bench testing and software validation.
Table of Acceptance Criteria and Reported Device Performance (Inferred/Missing)
| Feature/Test Area | Acceptance Criteria (Implicit for Substantial Equivalence/Standards) | Reported Device Performance (Specifics NOT provided in document) |
|---|---|---|
| Stimulation Output Waveforms | Should match specified waveform characteristics (e.g., rectangular, monophasic with hybrid stimulation) and demonstrate stability/consistency. | "Tests conducted" but specific measurement values (e.g., actual waveform shape, consistency over time) not provided. |
| Stimulation Output Specifications | Should meet specified ranges for Max Output Voltage, Max Output Current, Pulse Width, Frequency, Net Charge, Max Phase Charge. | Values provided in comparison tables (e.g., 50V @ 500Ω, 100mA @ 500Ω, 100-400μs, 5-125Hz). Implicitly met, but no specific "performance" results given as "was measured at X." |
| Stimulation Virtual Output Channels | Proper functioning and selection of all 24 virtual channels. | "Tests conducted" but no specific performance data given (e.g., success rate of channel selection). |
| Stimulation Output Channel Isolation | Meet specified isolation levels (e.g., -33 dB typical, -70 dB crosstalk) and demonstrate no unintended stimulation. | "Tests conducted" and implied to meet, citing IC manufacturer datasheet and bench test. No specific quantified result. |
| Hybrid Stimulation | Operates as designed, delivering 0 µC net charge using its hybrid method. | "Tests conducted" and implied to meet. No specific quantified result. |
| Stimulation Electrodes Short and/or Open Detection | System detects and responds appropriately to short/open circuit conditions. | "Tests conducted" but no specific performance data given (e.g., detection accuracy, response time). |
| Wireless Coexistence | Device functions without interference from/to other wireless devices. | "Tests conducted" but no specific performance data given (e.g., interference levels, reliability). |
| Electrical Safety (IEC 60601-1, -1-11; -2-10) | Compliance with all relevant clauses of these standards (e.g., leakage current limits, patient protection, functional safety for nerve stimulators). | "Passed" (stated compliance with standards). No specific measured values. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Compliance with EMC requirements (e.g., emission limits, immunity to interference). | "Passed" (stated compliance with standards). No specific measured values. |
| Software Validation (IEC 62304) | Software performs as intended, free from critical bugs, meets design specifications (including new biofeedback features). | "Verified and validated successfully." No specific test results, bug counts, or performance metrics. |
| Usability (IEC 62366, IEC 60601-1-6) | Device is safe and effective for use by intended users, minimal use errors. | "Leveraged from the predicate device submission." No new specific usability study results for NS-200. |
| EMG Performance (Sensitivity, Sampling Rate, Range, Bandwidth, Processing) | Meet specified values/ranges and accurately detect muscle activity as intended for biofeedback. | Values provided (e.g., 0.0298 μV sensitivity, 2kHz sampling rate, +/-2.5*10⁶ μV range, 10-500 Hz bandwidth, RMS processing). Implicitly met, but no specific "performance" results given as "was measured at X." |
| Biofeedback Mode Functionality | Visual biofeedback accurately reflects muscle activation; Muscle Activated Stimulation triggers consistently at 20% max activation. | Functionality described, but no quantitative performance data (e.g., accuracy of visual display, trigger latency, false positive/negative rates for stimulation). |
| Clinical Performance (Gait Improvement, Muscle Re-education, etc.) | Device provides intended therapeutic effects as described in Indications for Use. | Supported by "Summary of Literature Clinical Data" referencing an article on "Adaptive Functional Electrical Stimulation." No direct clinical trial results for NS-200 itself are presented here. |
Specific Information Requested and What is Available/Missing:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Mostly implicit compliance with safety standards (IEC 60601 series, 21 CFR 898) and technical specifications (e.g., voltage/current ranges, EMG parameters) for substantial equivalence to predicates. Explicit, quantitative acceptance thresholds for performance tests are not provided.
- Reported Device Performance: Specific quantitative results from testing (e.g., "The measured output voltage was XV, meeting the Y-V criterion") are not provided. The document states that tests "have been conducted" and the device "has been verified and validated successfully," implying compliance, but no actual performance data is listed. The tables compare specifications between devices, not measured performance results.
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not provided. The testing described is primarily non-clinical bench testing and software validation, not typically expressed in terms of "sample size" of subjects/patients.
- Data Provenance: The "Summary of Literature Clinical Data" references an article (https://www.medrxiv.org/content/10.1101/2022.04.27.22273623v2.full), which would be the source of any clinical data used to support the new indication for foot eversion. The document itself does not provide details on the study design or provenance of the data within that article.
- Retrospective/Prospective: Not specified for the non-clinical tests. For the referenced clinical article, it would depend on the study design of that external publication.
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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 describes non-clinical and software validation tests. There is no mention of "ground truth" adjudicated by experts for a test set in the context of AI/ML performance evaluation, as this is a medical device (neuromuscular stimulator) rather than an AI diagnostic algorithm.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. As above, this type of adjudication is typically for establishing ground truth in image interpretation or similar expert-driven data labeling, which is not described for this device's clearances.
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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 done (as described). An MRMC study is relevant for AI-assisted diagnostic tools. The Cionic Neural Sleeve is a functional neuromuscular stimulator; its clearance focuses on its mechanism of action, safety, and functionality, not its ability to assist human "readers" in interpreting data.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not explicitly stated as such. The device does have a software component with "advanced biofeedback capabilities." The software validation (IEC 62304) would assess the standalone performance of the algorithms. However, "standalone performance" in the context of AI often refers to metrics like AUC, sensitivity, specificity, etc., which are not provided here for any specific task. The document only confirms that the software was "verified and validated successfully."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical bench testing: The "ground truth" would be established by reference standards, calibrated equipment, and engineering specifications. For instance, a voltage meter would provide "ground truth" for output voltage.
- For the software validation: "Ground truth" would be defined by the software's design specifications and expected behavior.
- For the clinical support: The document references a published article ("Augmenting Gait in a Population Exhibiting Foot Drop with Adaptive Functional Electrical Stimulation"). The ground truth within that study would depend on its specific methodology (e.g., kinematic analysis, clinical outcome measures). The 510(k) does not perform primary ground truth establishment for clinical outcomes itself but rather leverages existing literature.
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The sample size for the training set:
- Not provided (and likely not applicable in the traditional AI/ML sense). The software features described (Visual Biofeedback Mode, Muscle Activated Stimulation Mode) are based on sEMG functionality. While such systems might involve some level of calibration or adaptive algorithms, the document doesn't mention a "training set" in the context of a machine learning model that learns from large datasets. Any internal calibration routines would be part of the software's inherent design, not a separate "training set" for a generalizable AI model.
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How the ground truth for the training set was established:
- Not applicable / Not provided for the reasons stated above.
In summary, this FDA 510(k) clearance document primarily serves to demonstrate substantial equivalence to existing devices based on technical specifications and compliance with recognized safety and performance standards via non-clinical bench testing and software validation. It is not a detailed clinical study report or an AI/ML algorithm validation report that would contain the specific performance metrics and ground truth establishment details you requested.
§ 882.5810 External functional neuromuscular stimulator.
(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).