(125 days)
Myo Plus is to be used exclusively for exoprosthetic fittings of the upper limbs.
MYO PLUS measures the electromyographic control signals of the user and assigns them to the movements of the prosthesis, such as the hand or rotation unit. The product is the central control unit of a myoelectric prosthesis. By calibrating via the Myo Plus App, the control unit learns to assign muscle signals from the user to the various types of movement. This calibration can be performed by the users themselves, and repeated at regular intervals if necessary.
Description of the components:
Myo Plus TR
The central control unit is installed in the forearm of the prosthesis and is supplied with energy by the battery system of the prosthesis. Up to 8 remote electrodes can be connected. The electronics handles the signal processing of the electrode signals and controls the compatible prosthesis components.
Remote Electrode
The remote electrodes take the muscle signal from the skin surface and transmit it to MyoPlus TR. The electrode contacts are located on a flexible cable and are individually screwed into the socket by the prosthesist.
Myo Plus App
The Myo Plus App is the central interface for the user and/or professionals to make settings on the control system or monitor operating states. The data transfer to mobile setting systems on Android or mobile iOS devices shall be carried out by a wireless connection according to the state of the art.
Mvo Cuff
The Myo Cuff is used to evaluate the muscle signals of a potential user of a Myo Plus controller. The Myo Cuff forms a flexible wristband which is temporarily applied to the user's forearm. Thus, the signal patterns of the user can be evaluated with the help of the app without the preparation of a complex test socket. If a user has problems separating the patterns at the beginning, he can also use the Myo Cuff for practicing with an professional.
Myo Plus trial kit
The Myo Plus trial kit provides the components of Myo Plus as a loaner kit for the prosthesist.
The provided text describes the Myo Plus device and its substantial equivalence to a predicate device, but it does not contain specific details about acceptance criteria or a study that proves the device meets those criteria in the context of a comparative effectiveness study involving AI assistance for human readers or standalone algorithm performance.
The document primarily focuses on demonstrating substantial equivalence based on:
- Identical Indications for Use
- Identical Principles of Operation
- Similar Technological Characteristics
- Compliance with recognized safety and performance standards (electrical safety, EMC, biocompatibility, battery safety)
- Results from general functional and performance tests.
There is no mention of an AI component, human readers, effect sizes, multi-reader multi-case studies, or the types of ground truth typically established for AI-driven diagnostic or assistive devices. The "Pattern recognition" mentioned refers to the device's ability to interpret muscle signals for prosthetic control, not image analysis or AI interpretation of medical data in a diagnostic context.
Therefore, I cannot extract the requested information from the provided text for the following reasons:
- Acceptance criteria and reported device performance related to AI/human reader studies: Not present. The acceptance criteria mentioned are related to functional performance (e.g., "Functional testing: Passed," "Pattern recognition: Passed") and compliance with safety standards.
- Sample size for test set and data provenance: Not mentioned.
- Number of experts and their qualifications for ground truth: Not mentioned.
- Adjudication method for test set: Not mentioned.
- MRMC comparative effectiveness study and effect size: No such study is described.
- Standalone (algorithm only) performance: No such performance evaluation is described. Myo Plus is a physical device (control unit for prosthetic limbs) that uses signal processing, not a standalone AI algorithm for medical image analysis.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the device's function would be the user's intended muscle movements and the device's accurate interpretation and execution of those movements, but this is not defined in terms of a clinical study or labeled dataset.
- Training set sample size and how ground truth was established for training: Not mentioned. The device "learns to assign muscle signals from the user to the various types of movement" through a calibration process via the Myo Plus App, which can be done by users themselves or with a professional. This is a user-specific calibration, not a large-scale AI model training process using a distinct training dataset.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).