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Myo Plus

Otto Bock Healthcare Products GmbH • Neurology • 09/04/2019

510(k)IEC 62304 Class B
FDA Summary PDF

Device Purpose

Myo Plus is an advanced cutaneous electrode system designed to control upper limb exoprostheses by measuring user-specific electromyographic signals and utilizing pattern recognition for intuitive movement assignment. The system empowers users through a mobile app for self-calibration and settings adjustment, aiming to enhance the functionality and personalization of prosthetic control.

Summary

The Myo Plus system is designed for exclusive use in exoprosthetic fittings of the upper limbs. Its core function involves measuring electromyographic (EMG) control signals from the user's muscles through remote electrodes. These signals are then processed by the central control unit, Myo Plus TR, which is installed in the forearm of the prosthesis and powered by the prosthesis's battery system. The Myo Plus TR unit interprets these EMG signals to control the movements of compatible prosthetic components, such as a hand or rotation unit, based on pattern recognition. Key components of the system include the Myo Plus TR central control unit, remote electrodes that capture muscle signals from the skin, and the Myo Plus App. This app serves as the primary interface for users and professionals to adjust settings, monitor operating states, and calibrate the control system. Calibration, which can be performed independently by the user, allows the system to learn and assign specific muscle signals to various prosthetic movements. Additionally, the Myo Cuff, a flexible wristband, is used to evaluate muscle signals of potential users and for training purposes without needing a complex test socket. Data transfer for settings and monitoring occurs via wireless Bluetooth connection to Android or iOS mobile devices.

AI Regulatory Concerns

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Keywords

Myo Plusexoprostheticupper limbelectromyographiccutaneous electrodepattern recognitionMyo Plus AppMyo Cuffprosthesis controlremote electrode

Device Metadata

Submission Number
K191179
Company
Otto Bock Healthcare Products GmbH
Panel
Neurology
Product Code
N/A
Data Type
Signals
Clinical Function
Assessment
AI Function
Analysis
AI Subclass
quantification/feature localization

Relevant Clinical Questions

  • Q1. What is the typical learning curve for new users to achieve proficient control of various prosthetic movements using the Myo Plus pattern recognition system?; How does the performance of Myo Plus, specifically its pattern recognition capabilities, compare to other myoelectric control systems in terms of intuitiveness and reduction of phantom limb pain, if any?; What are the long-term maintenance requirements and expected lifespan of the Myo Plus TR unit and remote electrodes under conditions of daily use?; Are there specific patient characteristics (e.g., level of amputation, muscle signal strength, cognitive ability) that predict greater success or difficulty with the Myo Plus system?; How does the Myo Cuff's pre-prosthetic assessment of muscle signals correlate with a user's functional outcomes and satisfaction after being fitted with a definitive Myo Plus controlled prosthesis?

Risk Classification

ESL Analysis
FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Authorized before §524B enforcement

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Cybersecurity Evidence

Powered by SBOMator™

Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.

Cyber Score20/100
SBOM Evidence⚠ Not mentioned in summary
Cyber Risk Assessment⚠ Not mentioned in summary
Postmarket Plan✓ Detected in Summary
§524B ApplicableNo

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials
- Not detected
ML-BOMMachine Learning Bill of Materials
- Not detected
SaaSBOMSoftware-as-a-Service Bill of Materials(remote, wireless, bluetooth)
✓ Detected
HBOMHardware Bill of Materials
- Not detected
CBOMCryptography Bill of Materials
- Not detected
VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange
- Not detected
OBOMOperations Bill of Materials
- Not detected

Analysis:

• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.

• Evidence of SaaSBOM detected in AI-generated device summary.

• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.

• Not detected in AI-generated device summary: SBOM, ML-BOM, HBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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Myo Plus - Otto Bock Healthcare Products GmbH | ESL FDA AI Device Intelligence