(12 days)
The MyoSystem with Customizing is intended for adult(s) who require an external electric upper extremity system.
The MyoSystem with Customizing is an adult external electric upper extremity system which allows the CPO to adjust all relevant parameters of the control of an external powered upper extremity prosthesis by a Personal Computer (PC). The system allows the connection of the control of a prosthesis with a PC by serial communication. A PC Software program allows the monitoring of how the patient performs with the prosthesis and enables the practitioner to change the control parameters according to the patient's needs. In addition, the practitioner can do the same program changes between control programs of a component as he/she can do by changing a colored coding plug. As it is a much faster process to change a program by the click of a button rather than to dismantle the prosthesis to gain access to the coding plug of a component, there is less disruption in the fitting process. This makes it less tiring for the patient and practitioner. As this system allows only additional adjustments to the existing adjustment possibilities by dials, there is no program change in the components, The same components which are used by the current conventional adjustment process are used with the adjustment process by CUSTOMIZING.
The provided text is a 510(k) summary for the Otto Bock MyoSystem with Customizing. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.
The document is a regulatory submission for premarket notification, focusing on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting specific performance study results against defined acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
Here's why each point cannot be addressed:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on describing the device and asserting substantial equivalence.
- Sample sized used for the test set and the data provenance: No test set or study data are mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set or ground truth establishment is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. This device is an external limb prosthetic system, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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).