Search Results

The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications. The ISI module option is intended for the specific purpose of allowing an injector to interface with a CT scanner.

The Medrad Stellant CT Injector System with ISI Module is a syringe-based fluid delivery system indicated for delivery of contrast media during computed tomography procedures. It is intended to be used for the specific purpose of injecting intravenous contrast medium into the human vascular system for computed the organy studies. The addition of the ISI Module option to the Stellant CT Injector System simply establishes an interface between the injector and the CT scanner. The Stellant CT Injector System with ISI Module is comprised of the same main components as the predicate device: an Injector Head, a Display Control Unit (DCU) and sterile disposables. The Imaging System Interface Module is added to the system as an accessory.

This is a 510(k) premarket notification for a medical device (Medrad Stellant CT Injector System with Imaging System Interface Module), not an AI/ML device. Therefore, the provided text does not contain information about acceptance criteria, study details, sample sizes, expert involvement, or ground truth relevant to AI/ML performance.

The document focuses on demonstrating substantial equivalence to a predicate device (Medrad Stellant CT Injector System K023183) by comparing features and intended use, rather than proving performance against specific acceptance criteria through a study.

Therefore, I cannot provide the requested information.

Here's why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: This document is about regulatory clearance (510(k) submission) based on substantial equivalence, not a performance study against specific acceptance criteria for a new AI/ML algorithm. The "reported device performance" in this context is the device's operational parameters and intended use, which are deemed equivalent to the predicate device.
2. Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML performance study described here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, test set, or expert review process described for an AI/ML algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no test set or adjudication process for an AI/ML algorithm.
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 device is an injector system, not an AI/ML diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. There is no ground truth for an AI/ML algorithm described.
8. The sample size for the training set: Not applicable. There is no AI/ML training set.
9. How the ground truth for the training set was established: Not applicable. There is no AI/ML training set.

Ask a specific question about this device