(90 days)
The Cionic Neural Sleeve NS-100 is intended to provide ankle dorsiflexion 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 the spinal cord). The Cionic Neural Sleeve NS-100 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 Cionic Neural Sleeve NS-100 may also:
- Facilitate muscle re-education
- Prevent/retard disuse atrophy
- Maintain or increase joint range of motion
- Increase local blood flow
The Cionic Neural Sleeve NS-100 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-100 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-100 is intended to provide ankle dorsiflexion and/or plantarflexion 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-100 electrically stimulates muscles in the affected leg to provide ankle dorsiflexion and/or plantarflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait.
The Cionic Neural Sleeve NS-100 system sales carton consists of the following components:
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- SL-100 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 two sizes: small, and medium.
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- DC-100 a portable battery-powered Control and Stimulation Unit that connects to, and is worn within the SL-100. The DC-100 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-100 and connect the DC-100 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-100 system:
- Replacement electrode pads.
The Cionic Neural Sleeve NS-100 requires a password-protected Cionic mobile application that is exclusively available to Cionic Neural Sleeve NS-100 users.
The Cionic Neural Sleeve NS-100 system consists of a software and hardware architecture that enables users to access a library exercise and augmentation programs. Programs can be added and removed from the user's mobile app. All exercise and assistance programs utilize a standard calibration and stimulation user interface that is extendible to future exercise and augmentation programs.
The provided FDA 510(k) summary for the Cionic Neural Sleeve NS-100 (K213622) does not include a detailed study proving the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, accuracy, or effect size for human readers with AI assistance.
The document focuses on demonstrating substantial equivalence to a predicate device (Bioness L300 Go System, K190285) rather than providing a standalone performance study with quantified acceptance criteria for diagnostic or assistive accuracy. The performance data presented is limited to non-clinical testing for safety and technical specifications, not clinical effectiveness in terms of how well it improves patient outcomes or how it performs against a measurable clinical metric.
Therefore, many of the requested items cannot be extracted directly from this document. However, I can provide what is available and clarify what is missing.
Acceptance Criteria and Device Performance (Based on Technical and Safety Testing)
While the document doesn't list quantitative clinical performance criteria, it outlines the non-clinical tests conducted to demonstrate the device performs as "intended" and is "substantially equivalent." The "reported device performance" in this context refers to its adherence to these technical and safety standards.
| Acceptance Criteria (Implied by non-clinical tests) | Reported Device Performance |
|---|---|
| Safety and Electrical Performance: | Demonstrated Compliance: |
| Compliance with IEC 60601-1 (Electrical Safety) | Compliant (Implied by "successfully verified/validated," "adhere to recognized/consensus electrical safety standards") |
| Compliance with IEC 60601-1-11 (Electrical Safety in Home Healthcare) | Compliant (Implied by "successfully verified/validated," "adhere to recognized/consensus electrical safety standards") |
| Compliance with IEC 60601-2-10 (Muscle and Nerve Stimulators) | Compliant (Implied by "successfully verified/validated," "adhere to recognized/consensus electrical safety standards") |
| Compliance with IEC 60601-1-2 (Electromagnetic Compatibility) | Compliant |
| Battery Safety (IEC 62133-2) | Compliant |
| Stimulation Output Waveforms meet specifications | Performed as intended |
| Stimulation Output Channels and Isolation meet specifications | Performed as intended |
| Hybrid Stimulation functions as intended | Performed as intended |
| Stimulation Electrodes Short and/or Open detection functions as intended | Performed as intended |
| Biocompatibility: | |
| Biological evaluation of medical devices according to ISO 10993-1 | Compliant |
| Usability and Software: | |
| Usability according to IEC 62366; IEC 60601-1-6 | Compliant ("successfully verified/validated") |
| Software validation according to IEC 62304 | Compliant ("successfully verified/validated") |
| Functional/Technological Equivalence (to Predicate): | |
| Provide ankle dorsiflexion and/or plantarflexion, assist knee flexion or extension | Yes, similar indications, with additional plantarflexion capability compared to predicate. |
| Facilitate muscle re-education, prevent/retard disuse atrophy, maintain/increase ROM, increase local blood flow | Yes, similar to predicate. |
| Other technological characteristics (e.g., output current, power density, control methods) | Found "Substantially equivalent," with differences considered minor and having no impact on safety and effectiveness. |
Detailed Information Regarding Study (Based on Document Analysis):
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Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/not provided in this summary. The document describes non-clinical bench testing and verification/validation processes, not a clinical study on a patient test set with performance metrics.
- Data Provenance: Not applicable, as it's not a clinical data set. It refers to non-clinical testing performed by the manufacturer, Cionic, Inc.
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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. Ground truth as typically defined for clinical or diagnostic performance studies is not established in this document, as it outlines technical and safety testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no mention of a human-reviewed test set or adjudication process for clinical performance.
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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:
- No. This is not an MRMC comparative effectiveness study involving human readers or AI assistance in a diagnostic context. The device is a functional neuromuscular stimulator, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies extensive standalone engineering verification and validation of the device's electrical, mechanical, software, and biocompatibility aspects. However, this is not a clinical "standalone performance" in the sense of an algorithm making a clinical decision without human intervention. The device's function is to directly stimulate muscles based on detected limb movement.
- The software was validated according to IEC 62304, and the overall system was "verified and validated successfully for its intended use through a combination of original bench testing and verification and validation of all software and firmware."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing, the "ground truth" was compliance with established engineering standards (e.g., IEC standards for electrical safety, biocompatibility, usability, software validation) and the device's design specifications. There is no clinical outcomes data or pathology-based ground truth presented in this summary for the purpose of demonstrating substantial equivalence.
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The sample size for the training set:
- Not applicable. This document does not describe an AI/machine learning model that would require a "training set" in the traditional sense for diagnostic or predictive performance. The device uses embedded sensors and a control unit to generate stimulation for functional assistance, implying a rule-based or control-loop system rather than a trained AI classification model.
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How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for an AI/machine learning model.
Summary of Conclusions from the Document:
The Cionic Neural Sleeve NS-100 underwent comprehensive non-clinical testing, including electrical safety, biocompatibility, usability, and software validation. Based on the results, Cionic Inc. concluded that the device is substantially equivalent to the predicate Bioness L300 Go System. The differences noted, such as the ability to provide plantarflexion and variations in technological characteristics (e.g., number of output modes, power sources, stimulation channels, clinician/user control interfaces, and trigger sources), were deemed "minor with no impact to safety and effectiveness" because they either represented a subset of the predicate's capabilities, adhered to recognized safety standards, or achieved similar functional outcomes through different but validated technological means.
§ 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).