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The MyoCycle is intended for general rehabilitation for:

1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Maintaining or increasing range of motion
5. Muscle re-education

The MyoCycle is a stationary Functional electrical stimulation (FES) cycle ergometer which is composed of:

1. a motorized cycle ergometer
2. an FES controller /stimulator
3. a stimulation cable which connects the controller / stimulator to cutaneous electrodes (at maximum 20 cutaneous electrodes for 10 channels)
4. cutaneous electrodes

This system allows a person with impaired lower extremity movement to undertake cycle ergometry both actively (utilized FES evoked lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor). The electric motor inside the MyoCycle ensures that the pedals always rotate at 35 revolutions per minute (r/min) (isokinetic cycling), so it automatically assists or resists the patient, depending on the magnitude and direction of the torque applied to the crank by the patient.

The system software has four different configurations:

1. Pro – allows for multiple users by storing unique user data that can be accessed by a unique user identification code; extended FES parameter adjustability; up to six channels of stimulation
2. Home – only stores data for one user; limited FES parameter adjustability; up to six channels of stimulation
3. Pro Plus (+) – same as Pro but allows for up to ten channels of stimulation and uses patient cabling with additional leads
4. Home Plus (+) – same as Home but allows for up to ten channels of stimulation and uses patient cabling with additional leads

The provided document is an FDA 510(k) clearance letter for the MyoCycle MC-2 device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, reported device performance metrics (numerical results), details about a test set (sample size, provenance), expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance data.

The document primarily focuses on demonstrating substantial equivalence through:

• Comparison of Indications for Use: Showing the MyoCycle MC-2 has substantially equivalent indications to the predicate device, with an added "muscle re-education" indication that is standard for this type of device and does not raise new safety/effectiveness questions.
• Comparison of Technological Characteristics: Highlighting similarities and minor differences (e.g., increased stimulation channels, wider parameter range, larger touchscreen, wireless communication, database interface) that do not raise new safety/effectiveness questions.
• Performance Data (Bench Testing): Stating that testing was conducted to ensure equivalent functionality and verify performance to specifications, primarily through a review of documentation and bench testing against recognized consensus standards (e.g., electrical safety, EMC, usability).

Therefore, I cannot populate most of the requested sections as the information is not present in the provided text.

Here's what can be extracted based on the document:

Acceptance Criteria and Study Details for MyoCycle MC-2

The FDA 510(k) submission for the MyoCycle MC-2 primarily relies on demonstrating substantial equivalence to a predicate device (MyoCycle MC-HP-1, K170132) rather than presenting new clinical performance data with numeric acceptance criteria for specific outcomes. The "performance data" referred to in the document pertains to bench testing against recognized consensus standards to ensure safety and functionality, not a clinical study to evaluate device effectiveness in patients.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes no specific quantitative acceptance criteria or reported device performance metrics in a clinical context (e.g., "device achieved X% accuracy," "device improved range of motion by Y degrees"). Instead, the "acceptance criteria" are implied to be the successful demonstration of:

• Substantially equivalent Indications For Use.
• Similar technological characteristics that do not raise new questions of safety or effectiveness.
• Compliance with recognized consensus standards for device safety and electrical performance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a test set in the conventional sense of a patient-based clinical study. The "testing" mentioned is primarily non-clinical bench testing and review of documentation. Therefore, information on sample size and data provenance for a clinical test set is not provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable, as no clinical test set requiring expert ground truth or adjudication is described.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not mentioned or described in the provided document. The submission focuses on substantial equivalence based on technological characteristics and bench testing, not on comparative clinical effectiveness with human readers/users.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. The MyoCycle MC-2 is a physical medical device (an FES cycle ergometer) rather than a software algorithm intended for standalone diagnostic or interpretive performance. Its functionality is tied to its interaction with a user.

7. The Type of Ground Truth Used

For the bench testing and design verification, the "ground truth" would be established by the specifications defined for the device and the requirements of the recognized consensus standards. For example, an electrical safety standard dictates specific performance criteria that the device must meet, and this standard serves as the "ground truth" for compliance. There is no mention of patient-level "ground truth" (e.g., pathology, outcomes data) for clinical efficacy.

8. The Sample Size for the Training Set

Not applicable. The document describes a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is described.

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The MyoCycle is intended for general rehabilitation for:

1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Maintaining or increasing range of motion

The MyoCycle is a stationary FES cycle ergometer which is composed of:

1. a motorized cycle ergometer
2. an FES controller / stimulator
3. a stimulation cable which connects the controller / stimulator to cutaneous electrodes (at maximum 12 cutaneous electrodes for 6 channels)
4. cutaneous electrodes
   This system allows a person with impaired lower extremity movement to undertake cycle ergometry both actively (utilized FES evoked lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor). The electric motor inside the MyoCycle ensures that the pedals always rotate at 35 revolutions per minute (r/min) (isokinetic cycling), so it automatically assists or resists the patient, depending on the magnitude and direction of the torque applied to the crank by the patient. The system software operates in two modes:
5. Pro mode allows for multiple users by storing unique user data that can be accessed by a unique user identification code
6. Home mode only stores data for one user

This document is a 510(k) summary for the MyoCycle Home and MyoCycle Pro devices, which are functional electrical stimulation (FES) cycle ergometers. It seeks to establish substantial equivalence to a predicate device, the RT300-S (K050036), manufactured by Restorative Therapies Inc.

Here's the breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum accuracy percentages, specific thresholds for safety measurements). Instead, it describes a series of tests performed to demonstrate substantial equivalence to a predicate device, validating its safety and effectiveness. The "reported device performance" is framed in terms of meeting recognized consensus standards and demonstrating similar functionality and safety characteristics to the predicate.

Given the information, the table would look like this, extrapolating "acceptance criteria" from the performed tests and implied equivalency:

2. Sample Sizes Used for the Test Set and the Data Provenance

The document describes several "testing" activities, primarily focused on verification and usability, rather than a traditional "test set" for an AI algorithm's performance against a ground truth.

• Lay Operators Test: 5 lay operators, with an able-bodied, simulated patient. (Likely prospective, country of origin not specified but assumed US given FDA filing)
• Clinician Operators Test: 7 clinician operators, with 6 spinal cord injured patients. (Likely prospective, country of origin not specified but assumed US)
• Patient Operators Test: 5 spinal cord injured patients, using the device without assistance. (Likely prospective, country of origin not specified but assumed US)

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable and not present in the document. The "testing" described is about evaluating device function, safety, and usability by various user types, not about establishing ground truth for an AI algorithm's diagnostic or predictive output. The "experts" involved are the clinician operators (7 of them), whose specific qualifications (e.g., years of experience, specific medical specialty beyond "clinician operator") are not detailed.

4. Adjudication Method for the Test Set

Not applicable as there is no specific "ground truth" to adjudicate for these functional and usability tests. The assessment would likely involve observing successful operation, gathering user feedback, and confirming adherence to operational specifications.

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. The MyoCycle is an FES cycle ergometer, not an AI-powered diagnostic or assistive tool for human readers. There is no AI component described in the context of improving human reader performance.

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

Not applicable. The MyoCycle is a physical medical device (an FES cycle ergometer) that primarily relies on its hardware and embedded software for its function, not a standalone AI algorithm operating independently. While it has embedded microcontrollers running custom software, this is for controlling the mechanical and stimulation aspects of the device, not a diagnostic or predictive AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Ground truth, in the context of evaluating an AI algorithm's performance against a known reality, is not a concept explicitly applied here. The "truth" being established is the device's adherence to engineering specifications, safety standards, and its ability to be used effectively by its intended operators (lay, clinician, and patient). This is achieved through direct performance verification and observation during testing.

8. The Sample Size for the Training Set

Not applicable. The MyoCycle is not an AI system that undergoes "training" on a data set in the way a machine learning model would. Its development would involve engineering design, prototyping, and iterative testing, not data-driven training.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the context of AI described for this device.

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