(427 days)
XFT-2001D Foot Drop System 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 XFT-2001D electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the individual's gait. Medical benefits of Functional Stimulation (FES) may include prevention/retardation of disuse attophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.
Nerve and Muscle Stimulator (Foot Drop System) is a battery-operated, electrical stimulator that can be used for functional electrical stimulation (FES). Nerve and Muscle Stimulator (Foot Drop System) is an external functional electrical stimulator. It is a small device that attaches to the leg just below the knee, near the head of the fibula. During a gait cycle, Nerve and Muscle Stimulator (Foot Drop System) stimulates the common peroneal nerve, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle. The Nerve and Muscle Stimulator (Foot Drop System) consists of the Patient Kit and the Clinician Kit. The Patient Kit comprises of all the components and accessories that the patient will take home and use. The Clinician System includes the Medical Records Management Software.
The provided text is a 510(k) summary for the XFT-2001D Foot Drop System, which seeks to demonstrate substantial equivalence to a predicate device (WalkAide, K123972). This document primarily details a comparison of the proposed and predicate devices' technical specifications and outlines the performance testing conducted to support safety and effectiveness. It does not present a study with specific acceptance criteria and reported device performance in the context of clinical efficacy or accuracy metrics for AI/ML-driven devices.
The "Performance Data" section (Page 10) focuses on regulatory compliance testing rather than clinical study results. It mentions:
- EMC and Electrical safety: Compliance with IEC 60601-1-2:2014, IEC 60601-1:2005, and IEC 60601-2-10:2012. These are standards for the basic safety and essential performance of medical electrical equipment, including electromagnetic disturbances and specific requirements for nerve and muscle stimulators.
- Biocompatibility: Evaluation of electrode pads (K132588) per ISO 10993-5:2009 (in vitro cytotoxicity) and ISO 10993-10:2010 (irritation and skin sensitization).
- Software Verification and Validation: Conducted for a "MODERATE" level of concern software, following FDA guidance for software in medical devices.
Therefore, many of the requested elements for a deep dive into AI/ML study specifics (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not present in this document.
However, I can still extract information based on the type of "acceptance criteria" and "study" described in the document, which are regulatory compliance focused.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
For this device, the "acceptance criteria" are compliance with established international standards for medical electrical equipment and software. The "reported device performance" indicates that the device met these standards.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard/Guidance) | Reported Device Performance |
|---|---|---|
| EMC and Electrical Safety | IEC 60601-1-2:2014 (Electromagnetic disturbances) | Device complies with the standard. |
| IEC 60601-1:2005 (Basic safety and essential performance) | Device complies with the standard. | |
| IEC 60601-2-10:2012 (Nerve and muscle stimulators) | Device complies with the standard. | |
| Biocompatibility | ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | Evaluation conducted according to the standard. |
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Evaluation conducted according to the standard. | |
| Software V&V | FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (for "MODERATE" level of concern software) | Software verification and validation testing were conducted and documentation provided as recommended. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes compliance testing for electrical safety, EMC, biocompatibility, and software V&V, which typically involve laboratory tests on devices and materials, not clinical "test sets" with patient data in the way an AI/ML diagnostic device would.
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 information is not applicable for the type of testing described (regulatory compliance for an external functional electrical stimulator). Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or outcomes, which are not part of this submission's performance data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the type of testing described.
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 study was not done. This type of study is relevant for AI-assisted diagnostic or interpretive devices. The XFT-2001D is an external functional electrical stimulator, not an interpretive AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm (in the context of AI/ML) was not done. The software V&V was conducted for the device's operational software at a "MODERATE" level of concern, indicating its impact on device function rather than a diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the specific performance data presented (EMC, electrical safety, biocompatibility, software V&V), the "ground truth" is defined by the standards themselves. For example, a device's electrical leakage current measurement must be below a certain threshold specified in IEC 60601-1. There isn't "ground truth" derived from patient outcomes or expert consensus in the way it's understood for AI/ML diagnostic tools.
8. The sample size for the training set
This information is not applicable as the device is not an AI/ML-driven diagnostic or predictive model in the context of the provided document. The software mentioned is for the device's operational control, not for "training" algorithms.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" in the context of an AI/ML model for this device's 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).