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MyndMove and MyndMove 2.0 are electrical stimulation devices indicated for the following uses:

Functional electrical stimulation (FES)

Improvement of arm and hand function 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) for general rehabilitation for:

• · maintenance and/or increase of arm and hand range of motion,
• · prevention and/or retardation of disuse atrophy,
• · increase in local blood circulation,
• · reduction in muscle spasm, and
• · re-education of muscles.

MyndMove and MyndMove 2.0 therapies can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove 2.0 Systems.

The MyndMove and MyndMove 2.0 Systems are neuromodulation devices that deliver short electrical pulses to stimulate muscle contractions and enhance motor recovery following Stroke or Spinal Cord Injury. The MyndMove and MyndMove 2.0 systems comprise the Stimulator device, stimulation electrodes and cables, hand and foot switches, and integrated software.

The Functional Electrical Stimulators in the MyndMove 2.0 are eight-channel devices 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/MyndMove 2.0 Stimulator is connected, via an IEEE 802.11 a/b/g/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 2.0 ecosystem including but not limited to patient unique IDs and prescriptions, therapist profiles and stimulation protocols.

MyndMove and MyndMove 2.0 use 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 and MyndMove 2.0 are 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 or MyndMove 2.0 protocols achieve a wide range of functions. During the delivery of MyndMove 2.0 therapy, the patient executes functional tasks with assistance from the MyndMove/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 a movement. 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 a 510(k) summary for the MyndMove and MyndMove 2.0 electrical stimulation devices. It aims to demonstrate substantial equivalence to previously cleared predicate devices (MyndMove K170564 and MyndMove 2.0 K212149).

The key takeaway is that no new acceptance criteria, performance studies, or clinical data were generated or required for this 510(k) submission (K233006). The submission explicitly states: "No additional non-clinical performance testing was conducted because there was no change to the hardware or software since clearances of MyndMove (K170564) and MyndMove 2.0 (K212149)."

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this specific submission (K233006) refer to the previously established criteria and studies for the predicate devices. The document essentially argues that since the new submission's devices are identical in technological characteristics and therapy protocols to the cleared predicates, they inherently meet the acceptance criteria validated by the predicate studies.

However, to answer your request fully, I will extrapolate the "acceptance criteria" and "reported device performance" based on the "Substantial Equivalence Discussion" table, which compares the subject devices (MyndMove and MyndMove 2.0) to their predicates across various technical specifications. The acceptance criteria, in this context, are the specifications of the predicate devices that the subject devices are claiming to be identical to.

1. Table of Acceptance Criteria and the Reported Device Performance

Since the submission explicitly states there are no changes to the technological characteristics of MyndMove or MyndMove 2.0, the "reported device performance" for the subject devices (MyndMove and MyndMove 2.0 in K233006) is asserted to be identical to the predicate devices. The "acceptance criteria" are the specifications of the predicate devices.

Regarding the Study that Proves the Device Meets the Acceptance Criteria:

The current 510(k) (K233006) for MyndMove and MyndMove 2.0 relies entirely on the previous clearances of K170564 (MyndMove) and K212149 (MyndMove 2.0). The submission explicitly states: "No additional non-clinical performance testing was conducted because there was no change to the hardware or software since clearances of MyndMove (K170564) and MyndMove 2.0 (K212149).". This indicates that the "study" proving the device meets acceptance criteria was performed for the predicate devices. The current submission's argument is based on the substantial equivalence of the subject devices to these previously cleared predicates, meaning they share the same technological characteristics, indications for use, and therapy protocols.

Therefore, the following information relates to the predicate devices' original submissions, as K233006 did not involve new testing. This document does not provide details on the original studies for the predicate devices, but typically such studies would have addressed:

2. Sample size used for the test set and the data provenance: Not provided in K233006 document. The original predicate submissions (K170564 and K212149) would have outlined any clinical studies, their sample sizes, and whether the data was retrospective or prospective, and its geographical origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in K233006 document. If clinical performance was assessed (likely in the predicate submissions), the ground truth for patient outcomes or assessments would typically be established by qualified medical professionals (e.g., physical therapists, occupational therapists, neurologists), but the specific number and qualifications are not detailed in this current summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in K233006 document. This would depend on the nature of any clinical studies for the predicate devices.
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: Not applicable or provided. These devices are functional electrical stimulators for rehabilitation, not imaging analysis tools that typically use MRMC studies with "human readers" and "AI assistance." The "assistance" is the stimulation aiding patient movement, not an AI interpreting medical images.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable in the AI sense. The device requires human professionals (Occupational or Physical Therapy professionals) to administer the therapy, making it a human-in-the-loop system. There's no "algorithm-only" performance for the therapeutic effect. However, the device's software and hardware components would have undergone standalone verification and validation to ensure they meet their design specifications and safety standards as detailed under "Summary of Non-Clinical Testing" (e.g., IEC 62304 for software life cycle processes).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated for the predicate studies in K233006. For an FES/NMES device, ground truth for clinical effectiveness would typically involve outcomes data such as changes in objective measures of arm/hand function (e.g., Fugl-Meyer Assessment, Action Research Arm Test), active range of motion, muscle strength, and patient-reported outcomes, as assessed by trained therapists or clinicians.
8. The sample size for the training set: Not provided in K233006 document. If any machine learning components were involved in the development of the predicate devices (which is typical for "coded therapeutic algorithmic protocols"), a training set would have been used. This summary does not give such details.
9. How the ground truth for the training set was established: Not provided in K233006 document. Similar to point 8, this information would be specific to the development of the predicate devices.

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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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