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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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