(302 days)
Nerve and Muscle Stimulator (Model: XFT-2001EA) is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of walking, the Nerve and Muscle Stimulator (Model: XFT-2001EA) electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the individual's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle reeducation, and maintained or increased joint range of motion.
Nerve and Muscle Stimulator (Model: XFT-2001EA) is a wearable and DC 3.7V rechargeable lithium battery powered multifunction device, and integrated metal (stainless-steel) electrodes, offering Functional Electrical Stimulation (FES) in device. It can be attached to the leg just below the knee, near the head of the fibula. During a gait cycle, the Nerve and Muscle Stimulates the common peroneal nerve via metal electrode, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle.
The Nerve and Muscle Stimulator is a microprocessor-controlled device, and uses a smart phone operating application (APP) to store device, user and configuration information via Bluetooth. it can be operated by both smart phone application and the control panel of the device.
Nerve and Muscle Stimulator has 3 working mode, Walk Mode, Training Mode and Evaluation Mode. The walk mode and training mode which can give certain electrical pulses through metal electrode to the proposed area of the leg where the Nerve and Muscle Stimulator are placed. There is no electrical stimulation in the evaluation mode, it is intended to collect the tilt angle data generated by the Stimulator during the patient's walking, and can calculate the recommend parameters based on the collected data.
The control panel of the device has the operating elements of ON/OFF touch button, OLED display, mode selection touch button, intensity touch button and USB port for battery charging. The OLED display can show battery power, selected mode, current intensity and indication of a pause.
The stimulator will connect the APP via Bluetooth, user can set the parameters, mode selection, and intensity adjustment of the stimulation by APP. Logout of the APP or disconnect the Bluetooth, the stimulator can continue to work.
This FDA 510(k) summary is for a medical device (Nerve and Muscle Stimulator, Model: XFT-2001EA) seeking clearance based on substantial equivalence to a predicate device (XFT-2001D). The document primarily focuses on demonstrating that the new device is as safe and effective as the predicate, rather than providing a detailed study proving it meets specific clinical or diagnostic acceptance criteria for a novel functionality.
Given the nature of a 510(k) submission for substantial equivalence where clinical data is often not required for device performance, the document relies heavily on comparison to a predicate device and compliance with established electrical, biocompatibility, and performance standards. It does not contain information typically found in a clinical study report that would establish specific acceptance criteria for diagnostic performance or treatment efficacy.
Therefore, many of the requested sections (e.g., sample size for test set, data provenance, ground truth establishment for test/training sets, adjudication methods, MRMC studies, standalone performance) are not present in this type of regulatory submission. The document focuses on bench testing and comparisons to established safety and performance parameters rather than human-centric performance metrics.
However, I can extract the relevant information regarding acceptance criteria and the "study" (which in this context refers to non-clinical testing performed for regulatory clearance) that demonstrates the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical thresholds within the document, but are implicitly defined by compliance with specified international and national standards, and by showing equivalence or acceptable differences compared to the predicate device. The "reported device performance" is largely demonstrated through successful completion of these compliance tests.
| Acceptance Criterion (Implicit) | Reported Device Performance (Demonstrated by) |
|---|---|
| Electrical Safety and Essential Performance (IEC 60601-1) | Device passed safety testing according to ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) (IEC 60601-1:2005, MOD). |
| Electromagnetic Compatibility (IEC 60601-1-2) | Device passed IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests. |
| Home Healthcare Environment Compliance (IEC 60601-1-11) | Device passed IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. |
| Nerve and Muscle Stimulator Specific Safety (IEC 60601-2-10) | Device passed IEC 60601-2-10:2012+AM1:2016 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators. |
| Wireless Coexistence (ANSI/IEEE C63.27, FCC Part 15 Subpart C & B) | Device passed ANSI/IEEE C63.27:2017 American National Standard for Evaluation of Wireless Coexistence and FCC Rules and Regulations, Part 15, Subpart C and Subpart B. Wireless control noted as "meeting requirements of wireless coexistence," ensuring "quality of wireless could be assured during normal use." |
| Rechargeable Battery Safety (IEC 62133-2) | Rechargeable lithium battery passed IEC 62133-2:2017. |
| Biocompatibility (ISO 10993-5, ISO 10993-10) | Device passed biocompatibility tests according to ISO 10993-5:2009 (Tests for in vitro cytotoxicity) and ISO 10993-10:2010 (Tests for irritation and skin sensitization). Differences in electrode and cuff materials from the predicate were addressed by these tests. |
| Performance Testing (FDA Guidance for Powered Muscle Stimulators) | Device conducted and passed performance testing according to FDA guidance "Guidance Document for Powered Muscle Stimulator 510(k)s, document issued on June 9, 1999." Although specific numerical output parameters (Max Output Current, Frequency, Max Current Density, Max Average Current, Max Average Power Density) differed from the predicate, they were found to be "within the acceptable range by comparison with the device which previously cleared" and "do not impact safety and effectiveness." |
| Substantial Equivalence to Predicate | The device is concluded to be substantially equivalent to the predicate device (K162718) based on intended use, technological characteristics, output mode, and applicable safety standards. Differences (power source capacity, number of output modes, specific electrical output parameters, electrode size/shape/materials, cuff materials, wireless control mechanism, weight, dimensions) were individually evaluated and found not to "raise any new issues or concerns of safety or effectiveness" because they either complied with standards, were within acceptable ranges of previously cleared devices, or were demonstrated safe/effective through specific non-clinical tests (e.g., biocompatibility, wireless coexistence). |
Detailed Breakdown of Requested Information (based on the provided document):
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: As detailed in the table above, the acceptance criteria are largely defined by compliance with specific international and national standards (e.g., IEC 60601 series, ISO 10993 series, ANSI/IEEE C63.27, FCC regulations) and by the demonstration that any differences from the predicate device do not raise new safety or effectiveness concerns.
- Reported Device Performance: The reported performance is the successful passing of all listed non-clinical tests based on these standards and the justification for differences from the predicate.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document describes non-clinical bench testing. It does not involve a "test set" in the context of patient data. Therefore, sample size, data provenance, and retrospective/prospective nature are not applicable or detailed for human-subject data. The "test sets" would refer to the specific units of the device models (XFT-2001E, XFT-2001EA) used for the various bench tests.
-
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):
- Not applicable. This is a 510(k) submission for a non-diagnostic, therapeutic device, and the clearance is based on non-clinical testing and substantial equivalence, not on expert-adjudicated performance against a "ground truth" derived from patient data. The "ground truth" here is compliance with engineering and biocompatibility standards, assessed by testing laboratories.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no human-reader adjudication for performance of this device in this submission.
-
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 a nerve and muscle stimulator, not an AI-powered diagnostic tool. No MRMC study was performed or mentioned.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "standalone performance" in this context refers to the device itself meeting the performance and safety standards through bench testing. The document states that the proposed device "passed safety testing" and "passed biocompatibility tests" and "conducted and passed performance testing-bench." This directly addresses the standalone performance of the physical device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this regulatory submission is compliance with established international and national medical device safety and performance standards (e.g., IEC 60601 series, ISO 10993 series, FCC regulations) and FDA guidance for similar devices. It is based on objective, quantifiable measurements performed during bench testing by accredited laboratories and assessed against the requirements of these standards.
-
The sample size for the training set:
- Not applicable. This device is not an AI/machine learning device that requires a training set in the conventional sense.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/machine learning algorithm described in this submission.
§ 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).