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MYNDMOVE is an electrical stimulation device indicated for the following uses:

Functional Electrical Stimulation (FES)

Improvement of ann and hand functions and active range of motion in patients with hemplegia due to stroke or upper limb paralysis due to C3-T1 spinal cord injury.

NeuroMuscular Electrical Stimulation (NMES)

· Maintenance and/or increase of arm and hand range of motion

• · Prevention and/or retardation of disuse atrophy
• · Increase in local blood circulation
• · Reduction of muscle spasm
  · Re-education of muscles.

Myddlove therapy can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by Mynd Tec on the use of the MyndMove System.

The MyndMove 2.0 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 2.0 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 2.0 Therapy can only be administered by trained MyndMove Therapy professionals (TMMT) with assigned Therapist Log-In IDs. TMMTs are Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove system.

MyndMove 2.0 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 2.0 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 2.0 protocols achieve a wide range of reaching and grasping functions. During the delivery of MyndMove 2.0 therapy, the patient executes functional tasks with assistance from the therapist and the MyndMove 2.0 device. The patient attempts to perform the movement and is then assisted to complete the movement when the therapist activates the MyndMove 2.0 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-damaged areas of the central nervous system can be trained to substitute for injured areas.

The provided text is an FDA 510(k) summary for the MyndMove 2.0 device, which is an electrical stimulation device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (MyndMove K170564) rather than providing a detailed study proving the device meets general acceptance criteria in a clinical performance context.

Therefore, many of the requested details about acceptance criteria for clinical performance and specific study methodologies (like sample size for test sets, number of experts, adjudication, MRMC studies, standalone algorithm performance, and training set details) are not present in this type of regulatory submission document. This 510(k) summary focuses on technical equivalence and safety standards compliance due to minor modifications to an already cleared device.

However, I can extract information related to technical performance and safety compliance acceptance criteria, and the study (testing) that proves the device meets these criteria, based on the provided text.

Here is a breakdown of the available information:

Acceptance Criteria and Device Performance (primarily technical and safety-related):

Study (Testing) Proving Device Meets Acceptance Criteria:

1. Sample size used for the test set and the data provenance:

   • For the technical performance and safety standard compliance, no specific sample size for a "test set" in a clinical trial sense is mentioned. Compliance was verified through Third Party testing for the relevant IEC standards and internal performance testing.
   • For the scapula anatomical site addition: "Testing was performed... on 3 healthy volunteers."
   • Data Provenance: Not explicitly stated for all testing. For the scapula protocol validation, it was performed at "a clinical site called Lyndhurst and the Toronto Rehabilitation Institute of the University Health Network of the University of Toronto" (Canada). This implies prospective testing for this specific modification. General IEC compliance testing is typically laboratory-based.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the document as it's not a clinical performance study involving expert reads for ground truth.
   • For the scapula protocol validation, the "objective was to test each protocol on each subject to ensure that the induced motions achieve the desired motions per the described use cases." This likely involved observation by a qualified professional (e.g., physiotherapist), but no specific "expert" panel or "ground truth" establishment in a traditional clinical validation sense is described.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This information is not provided as it's not a clinical performance study with subjective assessments requiring adjudication.

4. 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 MRMC comparative effectiveness study was done or reported. The device is an electrical stimulator, not an AI imaging or diagnostic tool where MRMC studies are typically performed.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The device is a medical device, not an AI algorithm intended for standalone diagnostic performance. Therefore, no such standalone algorithmic performance study was done or reported.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For technical and safety performance: Compliance with recognized international standards (e.g., IEC 60601 series) serves as the "ground truth" or benchmark. This is verified through objective testing (oscilloscope tracings, leakage current measurements, etc.).
   • For the scapula protocol addition: The "ground truth" was whether the "induced motions achieve the desired motions per the described use cases." This appears to be a functional verification, likely observed by therapists, rather than a diagnostic ground truth.

7. The sample size for the training set:

   • This information is not applicable as the device is not an AI or machine learning model that requires a training set in the conventional sense.

8. How the ground truth for the training set was established:

   • This information is not applicable for the reasons stated above.

Summary of the Study/Testing:

The "study" or testing described in this 510(k) summary is primarily focused on demonstrating technical and safety compliance of the modified MyndMove 2.0 device with relevant medical device standards, and confirming that the modifications (e.g., removed battery, new tablet material, home-use capability, new anatomical protocols, altered current for electrodes) do not negatively impact its safety or essential performance compared to the predicate device.

• Main tests: Third-party testing for compliance with IEC 60601-2-10, ES60601-1, 60601-1-2, 60601-1-11, 62304, and 60601-1-6. Internal performance testing.
• Specific validation for new protocols: For the addition of scapula protocols, there was "planned validation testing on 3 healthy volunteers" to ensure "induced motions achieve the desired motions." This was done at a clinical site, with "All verification and validation... successfully performed per the design and development plans and under REB decision."

The document concludes that the MyndMove 2.0 device is "substantially equivalent" to its predicate based on these technical and functional assessments, not on clinical performance metrics typically associated with diagnostic AI or imaging devices.

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