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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:

1. 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.
2. Sample size for test set and data provenance: Not mentioned.
3. Number of experts and their qualifications for ground truth: Not mentioned.
4. Adjudication method for test set: Not mentioned.
5. MRMC comparative effectiveness study and effect size: No such study is described.
6. 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.
7. 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.
8. 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.

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The stimulation system is intended to provide ankle dorsiflexion or extension in individuals with foot drop and thigh muscle weakness following an upper motor neuron injury or disease.

During gait, the stimulation system sends electric stimuli to muscles in the affected leg, initiating dorsiflexion of the foot and knee extension or flexion and may thus improve the individual's gait. The stimulation system may also prevent or retard atrophy caused by inactivity, facilitate muscle reeducation, maintain or improve the range of motion in the joints and promote local blood circulation.

The MyGait® Stimulation System is a battery-operated two-channel stimulator and was developed exclusively for everyday use during walking in an everyday environment.

The patient wears a wireless heel switch in a special sock. If the user is not able to put sufficient weight on the affected leg, he or she can wear the heel switch on the other foot. The heel switch registers heel lift and ground contact and thus the swing and stance phase. It transmits the information to the stimulator wirelessly.

The stimulator is located in a cuff that holds the electrodes. It is easy to put on, even with only one hand. The correct placement of the electrodes is achieved by the cuff. The stimulator delivers the electrical stimulation to the common peroneal nerve. The nerve stimulates for controlled dorsiflexion of the foot during the swing phase.

The second channel can be used independently of the first channel to provide stimulation to the knee flexors or knee extensors in patients with thigh muscle weakness.

Using the wireless remote control, the patient can control and adjust the stimulator settings. When the patient sits for an extended period, the sleep mode helps save energy.

The adjustment tool enables qualified personnel to adjust the stimulation parameters to the patient's individual needs. Stimulation parameters are used to affect movements in the foot. Examples of stimulation parameters are current, pulse width and shape, frequency, stimulation timing,

The "MyGait Soft" PC software is used to manage and analyze gait analysis data and stimulation parameters. The data is loaded from the stimulator to the adjustment tool. The stimulation parameters can be restored to the stimulator from the PC.

The Otto Bock Healthcare Products GmbH MyGait Stimulation System, referenced in K141812, did not report a clinical study on human subjects to determine device performance against acceptance criteria. Instead, substantial equivalence was established by comparing the technical characteristics and indications for use of the MyGait Stimulation System to three legally marketed predicate devices: WalkAide (K123972), Empi 300pv (K021100), and NESS L300 Plus System (K103343). The document primarily focuses on demonstrating that the new device's specifications fall within the range or are similar to those of the predicate devices, and that it complies with relevant electrical safety and electromagnetic compatibility standards.

Therefore, the following information cannot be fully provided as a traditional performance study was not conducted or reported in this 510(k) summary:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• Multi reader multi case (MRMC) comparative effectiveness study findings
• Standalone (i.e. algorithm only without human-in-the loop performance) findings
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

However, based on the provided document, here's a summary of the technical specifications and how they align with the substantial equivalence claim:

1. Table of Acceptance Criteria and the Reported Device Performance

Since this is a 510(k) for substantial equivalence based on technical comparison, there isn't a direct "acceptance criteria" table from a performance study. Instead, the "acceptance criteria" are implied by the ranges and characteristics of the predicate devices. The "reported device performance" are the MyGait's technical specifications.

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