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The Spectris Solaris MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and common flushing solutions into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) procedures. Only trained healthcare professionals are intended to operate this device.

The Medrad Spectris Solaris MR Injection System maintains the same intended use, similar operational parameters, similar labeling and is essentially used in a manner similar to the predicate device.

A label will be affixed to the 3.0 Tesla-compatible injector system stating that the injector should be placed at a minimum of 4 ft. from the magnet bore when used with magnetic resonance imaging scanners having a field strength greater than 2.0 Tesla. The user's manual has also been updated to include this warning.

The Spectris Solaris MR Injector (3T Compatible) is comprised of the same two main components as the predicate device - Injector Head/Stand (HSU) and Display Control Unit (DCU).

The provided text is a 510(k) Summary for the Medrad Spectris Solaris MR Injector System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel device. The changes described are primarily related to increasing the system's compatibility with higher magnetic field strengths (from 2.0 T to 3.0 T).

Therefore, the typical "acceptance criteria" and "study proving the device meets the acceptance criteria" as might be expected for a new AI/software-based medical device with performance metrics (like sensitivity, specificity, or accuracy) are not present in this document. Instead, the "acceptance criteria" are implied by showing the new device maintains similar operational parameters, similar labeling, and the same intended use as the predicate device, with the key difference being the expanded 3T compatibility.

Here's an attempt to answer your questions based on the available information, noting that many fields will be "Not Applicable" or "Not Provided" given the nature of a 510(k) for a hardware modification:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Provided. This type of detail is not typically included in a 510(k) summary for a hardware modification of this nature. The "study" here is primarily an engineering assessment of compatibility and equivalence to the predicate device.
• The comparison matrix explicitly states "Same" for most features, indicating that those parts of the system are unchanged and therefore assumed to perform identically to the previously cleared predicate. For the 3T compatibility, specific testing (e.g., electromagnetic compatibility, performance under higher magnetic fields) would have been performed, but the details (like sample size of tests or data provenance) are not summarized here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable/Not Provided. "Ground truth" in the context of diagnostic accuracy is not relevant here. This is a functional/safety equivalence submission for an injector system. The "experts" involved would be Medrad's own engineers and potentially external testing labs for aspects like EMC, but their qualifications and numbers are not part of the public 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable/Not Provided. Adjudication methods are typically for evaluating subjective interpretations, often in diagnostic imaging. This device is an injector, so such methods would not apply.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is not an AI or diagnostic imaging device. It's a contrast media injector.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. Not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. For this device, "ground truth" would relate to engineering specifications and performance metrics of the injector system (e.g., accuracy of flow rate, pressure limits, structural integrity, electromagnetic compatibility). These are objective measurements against established engineering standards and specifications, not subjective medical diagnoses.

8. The sample size for the training set

• Not Applicable. This device does not use a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

• Not Applicable. This device does not use a "training set."

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The Spectris Solaris MR Injection System is a syringe-based fluid delivery system for the delivery of contrast media during computed tomography applications. It is intended to be used for the specific purpose of injecting intravenous contrast media into a patient's vascular system for diagnostic imaging. Only trained healthcare professionals are intended to operate this device.

syringe-based fluid delivery system

This document is a 510(k) premarket notification approval letter for the Medrad Spectris Solaris Injector System. It does not contain information regarding acceptance criteria, device performance studies, or details about ground truth establishment, sample sizes for training/testing, or expert qualifications.

The letter explicitly states that the FDA has reviewed the 510(k) and found the device substantially equivalent to legally marketed predicate devices. This means that the manufacturer presented evidence to the FDA demonstrating that their device is as safe and effective as a device already on the market. The FDA approves the device based on this substantial equivalence, but the approval letter itself does not include the detailed study or performance data.

Therefore, I cannot provide the requested information from the provided text. The document is an approval letter, not a study report or a summary of performance data.

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