(105 days)
The MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation, including Stellant FLEX CT Syinge Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous imaging saline, into humans for diagnostic studies in computed tomography (CT) and mammography. For complete prescribing information, refer both to the current drug labeling for information relating to "imaging agent".
The MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation is a softwarecontrolled power injection system used for the administration of intravenous imaging agents, including saline, into humans for diagnostic studies in computed tomography (CT) and mammography. The system is comprised of an injector head and mount, a base, and a workstation. Commonly referred to as an automated injection system, it is designed to allow a user to fill disposable syringes to perform an injection with a user-programmed volume, flow rate and/or duration.
The provided text describes a 510(k) premarket notification for the MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation, primarily focusing on an administrative update to expand its indications for use to include mammography. This document does not contain the typical structure of a clinical study or performance evaluation with specific acceptance criteria and detailed results as one might find for an AI/ML medical device.
The "study" referenced is a systematic review of clinical literature (Zanardo, et al., 2019), not a new performance study conducted by the device manufacturer. Therefore, a direct table of acceptance criteria and reported device performance from a primary study on this device for mammography is not available in the provided text. The document focuses on demonstrating substantial equivalence by showing that existing clinical practices for Contrast-Enhanced Spectral Mammography (CESM) align with the capabilities of the MEDRAD® Stellant FLEX system.
Here's an attempt to answer your questions based on the provided text, while acknowledging the limitations:
1. Table of "Acceptance Criteria" and Reported Device Performance
As mentioned, there are no explicit "acceptance criteria" presented in the document in the format of a performance study for the device's expanded use in mammography. Instead, the document argues for substantial equivalence by demonstrating that the device's technical specifications align with standard practices reported in clinical literature for CESM.
The "reported device performance" refers to the device's technical specifications and capabilities, which are compared to the requirements for CESM as described in the Zanardo et al. review.
| Feature/Parameter (Implicit "Acceptance Criteria") | Reported Device Performance (as per comparison to predicate and literature) | Comments/Reference |
|---|---|---|
| Intravenous Imaging Agent Injection | Capable of injecting intravenous imaging agents, including saline. | Device description |
| Compatibility with CT/Mammography Diagnostic Studies | Indicated for diagnostic studies in CT and mammography. | Indications for Use |
| Single or Dual Syringe System | Dual syringe system. | Same as predicate |
| Volume Range (Syringe) | 1 to 200 ml or 1 to 150 ml (depending on syringe size). | Same as predicate |
| Fill Speed | 1.0 to 10.0 ml/s | Same as predicate |
| Flow Rate Range | 0.1 to 10 ml/s | Same as predicate. Matches/exceeds typical CESM flow rates (1.5-5 ml/s) |
| Pause Phase | 1 to 900 s | Same as predicate. Relevant for scan delays. |
| Programmable Pressure Limit | Choice of 50/345 to 325/2241 PSI/kPa | Same as predicate |
| Automated Power Injector Use | Automated injection system (software-controlled). | Device description. 85% of studies in Zanardo et al. used power injectors. |
| Saline Flush Capability | Dual syringe allows saline flush capability. | 62% of patients in Zanardo et al. received saline flush. |
| Contrast Agent Dosing/Concentration | Can deliver within approved dose ranges and routes. Matches example protocols in Zanardo et al. (1-2 ml/kg, 300 mg I/ml or higher). | Zanardo et al. review |
| Scan Delay Capability | Device configurable for scan delays. | Matches typical CESM scan delays (0.5 to 5 minutes, most commonly 2 minutes) in Zanardo et al. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for "Test Set": Not applicable in the context of this 510(k) submission as a new "test set" in the traditional sense was not generated for this device's performance in mammography. The reliance is on existing clinical literature.
- The Zanardo, et al. (2019) systematic review included 84 articles from 22 countries. These articles covered a total of 14,012 patients.
- Data Provenance: Retrospective, as it is a systematic review of previously published clinical studies. The data originates from various countries as indicated by the 22 countries of origin for the studies included in the review.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This question is not directly applicable. The Zanardo et al. systematic review aggregated data from numerous published studies, each with its own methodology, potentially involving many clinicians (experts) in their respective institutions. The review itself was conducted by its authors (M. Zanardo, et al.). The "ground truth" was established within the individual studies evaluated in the systematic review based on their diagnostic procedures and outcomes.
4. Adjudication Method for the Test Set
- Not applicable. The Zanardo et al. paper is a systematic review, not a study that involved expert adjudication of a new test set for this specific device.
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
- No, an MRMC comparative effectiveness study was not done, and this device (an angiographic injector) is not an AI/ML-based diagnostic device. The question regarding human reader improvement with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a hardware/software system for injecting contrast media, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in the context of the Zanardo et al. review would be the clinical diagnostic information and outcomes reported in the individual studies that were part of the systematic review. This would vary by study but would typically include various diagnostic findings from imaging (e.g., biopsy results, surgical pathology, clinical follow-up) that validated the contrast-enhanced mammography findings.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.