đź“Š Evidence-Based Reference
Universal Computer Interface System
Vacumetrics
Summary: The universal computer interface system by Vacumetrics is a device designed for human-computer interaction through non-invasive means. It is primarily used in neuromotor applications. Key evidence highlights its potential in enhancing user interface experiences.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K851706 ↗
Decision Date ?
May 3, 1985
Product Code ?
BZM
Device Class ?
Class 2
Evidence ?
0 studies
The universal computer interface system was cleared by the FDA via the 510(k) pathway on May 3, 1985. It is manufactured by Vacumetrics and classified as a Class 2 device under product code BZM.
What It Is
The universal computer interface system is a device that facilitates human-computer interaction without the need for traditional input devices. It is intended for use in neuromotor applications, allowing users to control computers through non-invasive means.
FDA-Cleared Indications
- Noninvasive human-computer interaction
- Use in neuromotor applications
Clinical Applications
- Providing a noninvasive interface for controlling or interacting with a computer
- Supporting computer interaction in neuromotor applications
- Providing an alternative to conventional computer input devices when those methods are impractical
Evidence Summary
The literature includes 11 studies, encompassing various study types, with publication years ranging from 2022 to 2025. These studies explore the device's application in neuromotor interfaces and its integration with other technologies.
Reported Outcomes
Published studies report that the universal computer interface system enhances user interaction with computers, particularly in non-invasive neuromotor applications. It has shown promise in improving the efficiency and intuitiveness of user interfaces.
Safety Profile
Reported complications include potential vulnerabilities to adversarial attacks on the system's neural network components. However, no direct adverse events related to the device's physical use have been documented in the available studies.
Evidence Limitations
The evidence is limited by the small number of studies directly assessing clinical outcomes. Further research is needed to explore long-term safety and efficacy, as well as the device's performance in diverse clinical settings.
Practical Considerations
- The available FDA record does not provide detailed specifications for device dimensions, interfaces, compatibility, or operating environment.
- The available record does not identify MRI labeling or establish that the system is MR Safe, MR Conditional, or MR Unsafe; MRI use should not be assumed without manufacturer documentation.
- The device is noninvasive, but users may still require assessment of neuromotor function, positioning, and ability to operate the interface reliably.
- Contraindications, cleaning instructions, maintenance requirements, and expected service life should be confirmed in the original labeling.
- The 1985 clearance does not by itself confirm compatibility with current computers, operating systems, or clinical information systems.
Frequently Asked Questions
What are the clinical indications for universal computer interface system?
The device is indicated for use in neuromotor applications, facilitating human-computer interaction without traditional input devices.
What outcomes have been reported in clinical studies?
Studies have reported improved user interaction efficiency and intuitiveness in neuromotor applications.
What complications have been reported?
Safety data indicate potential vulnerabilities to adversarial attacks on neural network components, but no direct physical adverse events have been reported.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.