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To be used in conjunction with a Magnetic Resonance Scanner to analyze data acquired using Blood Oxygen Level Dependent (BOLD) contrast techniques, such analysis that can be interpreted by a trained physician.

Eloquence is a stand-alone experiment presentation and post-processing workstation. The Eloquence package supports the visualization and analysis of MRI studies based on Blood Oxygen Level Dependent (BOLD) contrast. The image contrast differs between scans as a result of the variation of blood oxygenation through task performance by the subject (e.g., finger tapping). BOLD data can be processed with Eloquence to provide analysis based on standard statistical methods. Eloquence, described in this submission, provides dedicated visualization and analysis of MRI studies based on Blood Oxygen Level Dependent (BOLD) contrast which are useful for quantifying and visualizing small susceptibility changes in the human brain, created by the execution of specific tasks. These susceptibility images can presentation of information to support the diagnostic process. These images, when interpreted by a trained physician, vield information that may assist in diagnosis. Eloquence may also be used as a patient entertainment system, via its ability to deliver high quality audio and video to the patient.

The provided text is a 510(k) summary for a medical device called "Eloquence, Integrated Functional Imaging System." This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, a 510(k) submission for substantial equivalence generally does not involve new clinical studies with acceptance criteria and performance data in the same way a Premarket Approval (PMA) application would. Instead, it focuses on demonstrating that the new device is as safe and effective as devices already on the market through comparison to a predicate device.

Therefore, many of the requested elements (acceptance criteria, specific study details, sample sizes, ground truth establishment, MRMC studies, standalone performance) are not typically present or required in this type of submission unless the device introduces new technology or indications that necessitate new performance data.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as this is a 510(k) for substantial equivalence, not a performance study against predefined criteria for a new clinical claim.
• Reported Device Performance: Not reported in terms of specific metrics like sensitivity, specificity, etc., because actual performance data from a new study is not typically required to demonstrate substantial equivalence for this type of device and submission. The device is described in terms of its function (visualization and analysis of MRI studies based on BOLD contrast).

2. Sample Size for the Test Set and Data Provenance:

• Sample Size: Not applicable/not stated. No new clinical trials with test sets are described. The focus is on the device's functionality and its substantial equivalence to a predicate device, IFIS-SA.
• Data Provenance: Not applicable/not stated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Number of Experts: Not applicable/not stated. No test set requiring ground truth establishment by experts is described in this submission.
• Qualifications: Not applicable/not stated. The text mentions that analyzed data "can be interpreted by a trained physician," implying expertise is needed for interpretation, but this is not about establishing ground truth for a device performance study.

4. Adjudication Method:

• Adjudication Method: Not applicable/not stated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: Not mentioned. Such studies are typically for devices claiming to improve human reader performance, which doesn't appear to be the primary claim or requirement for this 510(k). The device is a "stand-alone experiment presentation and post-processing workstation" for analysis and visualization.
• Effect Size of Improvement: Not applicable/not stated.

6. Standalone Performance Study (Algorithm Only):

• Standalone Study: Not mentioned as a separate performance study. The device itself is described as a "stand-alone experiment presentation and post-processing workstation." However, this refers to its functional independence, not a standalone performance evaluation in a clinical trial context.

7. Type of Ground Truth Used:

• Ground Truth: Not applicable/not stated. No performance study requiring ground truth is described.

8. Sample Size for the Training Set:

• Sample Size: Not applicable/not stated. The document describes a post-processing workstation that applies "standard statistical methods" to BOLD data. There is no indication of a machine learning model requiring a training set in the context of this 510(k).

9. How Ground Truth for the Training Set Was Established:

• Ground Truth Establishment: Not applicable/not stated.

Summary of what the document does provide:

• Device Name: Eloquence, Integrated Functional Imaging System
• Intended Use: To provide dedicated visualization and analysis of MRI studies based on Blood Oxygen Level Dependent (BOLD) contrast, useful for quantifying and visualizing small susceptibility changes in the human brain created by task execution.
• Indications for Use: To be used in conjunction with a Magnetic Resonance Scanner to analyze data acquired using BOLD contrast techniques, such analysis that can be interpreted by a trained physician.
• Predicate Device: IFIS-SA, Integrated Functional Imaging System (K003505 and K003899).
• Safety Information: "No new safety hazards are introduced by the use of Eloquence."
• Classification: Class II, Product Code 90 LNH (Magnetic resonance diagnostic device).

In essence, this 510(k) demonstrates the device is substantially equivalent to a predicate by showing it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. It is not an document detailing the results of a primary clinical performance study with acceptance criteria.

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