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The MindState Functional Data Acquisition Device (fDAD) is used as a data acquisition tool in functional Magnetic Resonance Imaging (fMRI) procedures based on Blood Oxygen Level Dependent (BOLD) contrast.

fDAD presents a stimulus to the patient and collects the patient's responses from a button device. Execution of specific cognitional tasks by the patient (in response) generates functional data. The fMRI data comprised of the MR images (in DICOM format) sent from the MR scanner control station, and the behavioral response (binary) data are archived to a removable media by fDAD.

The fDAD-PT (fDAD Personal Trainer) is used to train the use of the four button response device and to ensure their understanding and successful execution of the specific task. A short activation task is presented on the fDAD-PT control station to ensure the patient is aware of the nature of the response to be provided.

The MindState Functional Data Acquisition Device (fDAD) is used as a data acquisition tool in functional Magnetic Resonance Imaging (fMRI) procedures based on Blood Oxygen Level Dependent (BOLD) contrast. fDAD presents a stimulus to the patient and collects the patient's responses from a button device. Execution of specific cognitional tasks by the patient (in response) generates functional data. The fMRI data comprised of the MR images (in DICOM format) sent from the MR scanner control station, and the behavioral response (binary) data are archived to a removable media by fDAD. The fDAD-PT (fDAD Personal Trainer) is used to train the use of the four button response device and to ensure their understanding and successful execution of the specific task.

I am sorry, but the provided text from the FDA 510(k) summary for the "MindState Functional Data Acquisition Device (fDAD)" does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria.

The document is a letter from the FDA to Neurognostics, Inc., confirming the substantial equivalence of their device to a legally marketed predicate device. It states that the device can proceed to market based on this determination.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• No Acceptance Criteria or Performance Data: The letter does not specify any performance metrics, thresholds, or acceptance criteria the device needed to meet. It also does not present any results from performance studies.
• No Study Details: The document does not describe any clinical or technical study conducted to support the device's performance. It doesn't mention sample sizes, data provenance, expert involvement, adjudication methods, or ground truth establishment.
• Focus on Substantial Equivalence: The primary purpose of this 510(k) letter is to declare that the device is "substantially equivalent" to a predicate device already on the market. This determination is often based on design, materials, and intended use similarities, rather than requiring extensive new performance data to be submitted for this specific device's approval. While a sponsor typically submits performance data to demonstrate substantial equivalence, those details are not included in this high-level FDA letter.

Therefore, I cannot provide the requested table or answer the specific questions about the study design and results. The provided text simply confirms the regulatory clearance for the device based on its substantial equivalence.

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The MindState Functional Data Acquisition Device (fDAD) is used as a data acquisition tool in the MRI environment to perform functional MRI (fMRI) procedures based on Blood Oxygen Level Dependent (BOLD) contrast. fDAD presents a stimulus to the patient and collects the patient's responses from a button (response) device. Execution of specific cognitive or motor activation tasks by the patient in response to a set of stimuli creates the necessary behavioral data. The fMRI data comprised of the MR images (in DICOM format) sent from the MR scanner control station, and the behavioral response (binary) data are archived to a removable media by fDAD. The fDAD-PT (fDAD Personal Trainer) is used to train the patient in the use of the four button response device and to ensure their understanding and ability to perform the specific task. A short activation task is presented on the fDAD-PT control station and the patient is allowed to become familiar with the nature of the activation task and the nature of the response to be provided.

The MindState Functional Data Acquisition Device (fDAD) is used as a data acquisition tool in the MRI environment to perform functional MRI (fMRI) procedures based on Blood Oxygen Level Dependent (BOLD) contrast. fDAD presents a stimulus to the patient and collects the patient's responses from a button (response) device. Execution of specific cognitive or motor activation tasks by the patient in response to a set of stimuli creates the necessary behavioral data. The fMRI data comprised of the MR images (in DICOM format) sent from the MR scanner control station, and the behavioral response (binary) data are archived to a removable media by fDAD. The fDAD-PT (fDAD Personal Trainer) is used to train the patient in the use of the four button response device and to ensure their understanding and ability to perform the specific task. A short activation task is presented on the fDAD-PT control station and the patient is allowed to become familiar with the nature of the activation task and the nature of the response to be provided.

The information provided does not contain a study or data proving the device met specific acceptance criteria. The document is a 510(k) clearance letter from the FDA for the MindState Functional Data Acquisition Device (fDAD), indicating that the device has been found substantially equivalent to a predicate device. This letter does not typically include detailed performance data or acceptance criteria for a new study.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness study results from the given text.

The text specifies the Indications for Use:
The MindState Functional Data Acquisition Device (fDAD) is used as a data acquisition tool in the MRI environment to perform functional MRI (fMRI) procedures based on Blood Oxygen Level Dependent (BOLD) contrast. It presents a stimulus to the patient and collects patient responses from a button device. It archives fMRI data (MR images in DICOM format) and behavioral response (binary) data to removable media. The fDAD-PT (Personal Trainer) is used to train patients on the use of the four-button response device and to ensure understanding and ability to perform specific tasks.

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