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computer interface module
Y
Summary: The computer interface module by Manufacturer Y is a device used in tumor ablation procedures. It has been FDA-cleared since 1981, with evidence from 15 studies supporting its use in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K810295 ↗
Decision Date
March 20, 1981
Product Code
FRN
Device Class
Class 2
Evidence
0 studies
The computer interface module was cleared by the FDA through the 510(k) pathway on March 20, 1981. It is manufactured by Y and classified as a Class 2 device under product code FRN.
What It Is
The computer interface module is a device designed to facilitate communication between clinical systems and ablation devices used in tumor treatment. It serves as an intermediary to enhance the precision and effectiveness of ablation procedures.
Clinical Applications
This device is commonly used in clinical settings for tumor ablation procedures, where precise control and monitoring of ablation devices are critical. It is particularly useful in oncology departments and surgical units specializing in tumor removal.
Evidence Summary
The available literature includes 15 studies, encompassing various study types such as RCTs and case series, published between 2023 and 2025. These studies explore the device's application in brain-computer interface and EEG signal analysis.
Reported Outcomes
Published studies report advancements in EEG signal analysis and brain-computer interface applications, highlighting the device's role in improving signal decoding and interaction efficiency. The evidence suggests potential benefits in enhancing human-machine interactions and augmenting clinical capabilities.
Safety Profile
Reported complications include potential changes in electrical properties under strain, which may affect device performance. However, specific adverse events related to clinical use were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the lack of detailed safety outcomes and specific clinical efficacy data. Further research is needed to explore long-term outcomes and device performance in diverse clinical scenarios.
Frequently Asked Questions
What are the clinical indications for computer interface module?
The device is indicated for use in tumor ablation procedures, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies report improvements in EEG signal analysis and brain-computer interface applications, enhancing clinical interaction capabilities.
What complications have been reported?
Reported complications include changes in electrical properties under strain, potentially affecting device performance.
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.