Search Results

The Integrated Stimulus Delivery System (ISDS), both Optimum and Premium models, is indicated for use by trained medical professionals to aid in the performance of functional Magnetic Resonance Imaging (fMRI) examinations based on Blood Oxygen Level Dependent (BOLD) contrast. The ISDS works with GE 1.5T and 3.0T Magnetic Resonance (MR) scanners with BrainWave™ software installed. The ISDS presents to the patient specific visual and audio stimuli with predetermined order and timing patterns and collects keypad responses; all ISDS functions are synchronized with the ongoing patient MR imaging examination.

For a patient undergoing a functional MR imaging examination the ISDS hardware components present visual and auditory stimuli to a patient and collect responses from that patient while the patient is in the bore of the MR scanner. Hardware components interface the ISDS computer system to the MR scanner in order to synchronize operation of the ISDS with the MR imaging procedure. The stimuli delivery (type of stimuli, stimuli presentation order, timing of stimuli presentation, etc.) is controlled by a proprietary software application.

The provided text describes a medical device, the Integrated Stimulus Delivery System (ISDS), and its intended use, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) summary for a submission to the FDA, detailing the device's description, intended use, and substantial equivalence to predicate devices. It states: "Summary of Testing: The ISDS has been tested and found to be safe and effective at meeting its requirements and intended use." However, it does not provide details about what those requirements were, nor does it present any specific performance metrics, study design, or results.

Therefore, I cannot populate the requested table or answer the specific questions regarding acceptance criteria and study details. The information necessary to do so is absent from the provided text.

Ask a specific question about this device