(184 days)
MYNDMOVE is an electrical stimulation device indicated for the following uses: Functional Electrical Stimulation (FES) o Improvement of arm and hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C3 - T1 spinal cord injury. NeuroMuscular Electrical Stimulation (NMES) o Maintenance and/or increase of arm and hand range of motion. o Prevention and/or retardation of disuse atrophy. o Increase in local blood circulation. o Reduction of muscle spasm. o Re-education of muscles. MyndMove therapy can only be administered by Occupational or Physical Therapists that have completed MyndMove training by MyndTec on the use of the MyndMove System.
The MyndMove System is a neuromodulation device that delivers short electrical pulses to stimulate muscle contractions and enhance motor recovery following Stroke or Spinal Cord Injury. The MyndMove system comprises the Stimulator device, stimulation electrodes and cables, hand and foot switches, and integrated software. The MyndMove Functional Electrical Stimulator is an eight-channel device with a touch screen user interface (UI). The Stimulator software allows the User to choose from a number of pre-programmed stimulation protocols, to customize the stimulation intensities for each patient, and to document the treatments provided. Each MyndMove Stimulator is connected, via an IEEE 802.11 a/b/q/n wireless radio adapter, to a cloud-based backend data management system. The primary function of the backend is to manage the various elements of the MyndMove ecosystem including but not limited to patient unique IDs and prescriptions, therapist profiles and stimulation protocols. MyndMove Therapy can only be administered by Trained MyndMove Therapists (TMMT) with assigned Therapist Log-In IDs. TMMTs are Occupational or Physical Therapists that have completed MyndMove training by MyndTec on the use of the MyndMove system. MyndMove uses surface electrical stimulation to produce muscle contractions in different combinations to achieve a wide range of reaching and grasping functions. To achieve these movements, the single use electrodes are placed in various combinations on the surface of muscles in the arm and hand. MyndMove is based on advanced functional electrical stimulation (FES) principles designed to promote neuroplasticity by influencing the efferent and afferent pathways. Proper sequencing of the muscle contractions as per the MyndMove protocols achieve a wide range of reaching and grasping functions. During the delivery of MyndMove therapy, the patient executes functional tasks with assistance from the therapist and the MyndMove device. The patient attempts to perform the movement and is then assisted to complete the movement when the therapist activates the MyndMove stimulation protocol, which generates bursts of short electrical pulses, using surface electrodes, to produce muscle contraction. In this manner, the patient gets both efferent and afferent input as they are actively attempting move and as the arm and/or hand is moved into the instructed position. Non-damaged pathways can be activated and non-damaqed areas of the central nervous system can be trained to substitute for injured areas.
Here's an analysis of the acceptance criteria and supporting studies for the MyndMove System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary provided does not explicitly list "acceptance criteria" in the typical quantitative sense for device performance. Instead, it details the technological characteristics of the MyndMove System and compares them to a predicate device (NESS H200 Wireless). The "acceptance" for this submission is based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical and clinical data indicating comparable safety and effectiveness.
However, the document highlights some performance aspects, particularly in the clinical summary. For the purpose of structuring a response consistent with your request, I will infer the "performance" as the clinical outcomes described in the referenced studies, specifically the MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke study.
| Acceptance Criteria (Inferred from Substantial Equivalence and Clinical Goal) | Reported Device Performance (from MyndMove clinical study) |
|---|---|
| Safety: Device operates without new questions of safety. | MyndMove System passed all electrical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ANSI/AAMI ES60601-1, IEC 60601-1-6, IEC 62304, IEC 62366-1). Electrode cables comply with 21 CFR 898. Patient-contacting accessories (electrodes, tape) comply with biocompatibility (ISO 10993-1). Human Factors evaluations (Lead-In, Formative, Validation) found the device safe and effective for use. |
| Effectiveness - Stroke (Arm and Hand Function Improvement): Demonstrates improvement in arm and hand function and active range of motion in patients with hemiplegia due to stroke. | In the "MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke" study (chronic cohort): 14 out of 24 (58%) people with chronic stroke realized clinically meaningful improvements in upper extremity voluntary mobility as measured by a gain of more than 5 points in the Upper Extremity Fugl-Meyer Score (UE-FM) after 20 one-hour sessions of MyndMove therapy. |
| Effectiveness - Spinal Cord Injury (Arm and Hand Function Improvement): Demonstrates improvement of arm and hand function and active range of motion in patients with upper limb paralysis due to C3-T1 spinal cord injury. | While the indications for use cover SCI, the provided clinical summary specifically highlights outcomes for stroke patients. The summary states that "This submission referenced the following clinical studies in both stroke and spinal cord injured populations using FES therapy," however, the details of a specific MyndMove study on SCI patients with performance metrics are not explicitly provided in the same format as the stroke study. It refers to previously published studies using FES therapy. |
2. Sample Size for the Test Set and Data Provenance
The primary clinical "test set" and its findings specifically for the MyndMove System is described for stroke patients:
- Study: "MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke" (chronic cohort).
- Sample Size (Chronic Cohort):
- Planned recruitment: 25 participants.
- Completed sessions: 24 of 25 individuals.
- Withdrawn for unrelated medical reasons: 1 participant.
- Effective Sample Size for results: 24 participants.
- Data Provenance: The document does not explicitly state the country of origin for this specific MyndMove clinical study. However, MyndTec Inc. is based in Mississauga, Ontario, Canada, suggesting Canadian origin is plausible. The study is described as "ongoing" and its results (for the chronic cohort) were reported by Hebert et al. at an Ontario Society of Occupational Therapists Conference in Kingston, Canada. This indicates it is a prospective clinical study.
Additional usability testing (also considered "clinical testing" in a broader sense for safety and effectiveness) was conducted:
- Lead-In Usability Evaluation: 5 end-user volunteers administering treatment to 5 healthy volunteers.
- Human Factors Formative Evaluation: 5 end-user/healthy volunteer pairs.
- Human Factors Validation Testing: 15 end-user participants delivered therapy to 15 healthy volunteer participants.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
For the MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke study, the ground truth for "clinically meaningful improvements" was measured by a "gain in UE-FM of more than 5 points." The UE-FM (Upper Extremity Fugl-Meyer Score) is a standardized, clinician-administered, objective assessment tool. The document implies that qualified clinicians (likely Occupational or Physical Therapists, given the context of MyndMove administration) administered this scoring. It does not specify the number of individual experts or their years of experience for the scoring itself within this specific study, but it does state that "MyndMove therapy can only be administered by Occupational or Physical Therapists that have completed MyndMove training by MyndTec." This suggests the evaluators would be similarly qualified.
Regarding the usability/human factors studies, the "ground truth" was established by observing "end-user volunteers" (Occupational or Physical Therapists) interact with the device and identifying usability issues.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (like 2+1, 3+1 consensus) for the clinical outcomes measured by the UE-FM score. Standardized clinical assessments like the UE-FM are typically administered by a single trained assessor, with inter-rater reliability often established for the tool itself in broader literature, rather than requiring case-by-case adjudication.
For the usability/human factors evaluations, the adjudication method essentially involved observing participant interactions and gathering subjective feedback, which would then be analyzed by the study coordinators.
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
The provided document describes a medical device, the MyndMove System, which is an electrical stimulation device for rehabilitation. It is not an AI/imaging device, and therefore, an MRMC comparative effectiveness study involving "human readers" and "AI assistance" is not applicable to this submission. The device directly delivers therapy rather than providing diagnostic information to human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Again, this is not an AI/imaging device. The MyndMove System is a hardware and software system that controls electrical stimulation. Its performance is tied to its output specifications and its clinical efficacy when administered to patients by trained therapists. There isn't a "standalone algorithm" performance in the sense of an AI performing a task independently. The device is the algorithm in terms of delivering stimulation protocols, but it explicitly requires human-in-the-loop (a trained therapist) for administration.
7. The Type of Ground Truth Used
For the clinical efficacy study on stroke patients ("MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke"), the ground truth was clinical assessment scores, specifically the Upper Extremity Fugl-Meyer Score (UE-FM). This is an objective, quantitative measure of motor impairment and function.
For the non-clinical testing (electrical safety, biocompatibility, usability), the ground truth was established by adherence to recognized international standards and FDA guidance documents, as well as observed user performance in simulated environments.
8. The Sample Size for the Training Set
The provided document does not indicate a "training set" in the context of machine learning. The device is a direct therapeutic electrical stimulator, not an AI model that learns from data.
However, if "training set" is broadly interpreted as any data used during development to refine the device or its protocols:
- The document states, "The MyndMove System incorporates the stimulation protocols used in the FES therapy for the above mentioned clinical studies and couples it with new hardware and software." It then references several published clinical studies (e.g., Popovic MR et al., Thrasher TA et al.) that used FES therapy with a "Compex electrical stimulation device." These studies would have informed the development and selection of the MyndMove's pre-programmed stimulation protocols. The sample sizes from these referenced studies vary, for example, Popovic et al. (2006) had 15 subjects, Popovic et al. (2005) had 14 subjects, Thrasher et al. (2008) had 15 patients, Popovic et al. (2011) and Desai et al. (2014) are also referenced, but specific sample sizes are not given in the 510(k) summary for these.
9. How the Ground Truth for the Training Set Was Established
As noted, there isn't a machine learning "training set" in the traditional sense. However, for the historical clinical studies that established the efficacy of FES protocols (which MyndMove then incorporates), the "ground truth" would have been established through clinical outcome measures (similar to the UE-FM used in the MyndMove-specific study), often compared against control groups or baseline measurements. These studies would have used objective assessments of motor function, range of motion, and other relevant clinical metrics to determine the effectiveness of the FES therapy.
§ 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).