Search Results

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.

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.

Ask a specific question about this device

MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation: The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.

MEDRAD® Stellant FLEX Syringe Kits: The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.

MEDRAD® Stellant CT Injection System with Certegra Workstation: The MEDRAD® Stellant CT Injection System with Certegra Workstation is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.

MEDRAD® Stellant Syringe Kits: The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors.

MEDRAD® Stellant Connector Tubing: The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors.

P3T Cardiac: P3T Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta.

P3T PA: P3T PA is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta.

P3T Abdomen: P3T Abdomen is indicated for use with CT imaging of abdominal organs (i.e., liver, pancreas, kidneys).

ISI: The ISI module option is indicated for the specific purpose of allowing an injector to interface with a CT scanner.

Connect.CT: The Connect. CT application is indicated for the specific purpose of allowing the injector to interface with a CT scanner.

The MEDRAD Stellant FLEX CT Injection System with Certegra Workstation is a software-controlled medical device used for the administration of intravenous CT contrast media and saline into the human vascular system for diagnostic studies in Computed Tomography (CT) procedures. 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 MEDRAD Stellant CT Injection System with Certegra Workstation is a software-controlled medical device used for the administration of intravenous CT contrast media and saline into the human vascular system for diagnostic studies in Computed Tomography (CT) procedures. 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 Stellant P3T software accessories compute individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration for individualized dosing, and for increasing the consistency of individualized injection protocols among clinicians.

The ISI module options allow an injector to interface with a CT scanner.

The Connect.CT application allows an injector to interface with a CT scanner.

The provided text describes a 510(k) premarket notification for contrast injection systems. The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than proving the efficacy of a new, novel technology with extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on engineering verification and validation, as well as human factors testing, to confirm that a modified device performs as safely and effectively as its predicate.

Here's an breakdown of the information requested, based on the provided text, and an explanation of why some fields are not applicable in this context.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a precise "table of acceptance criteria" with numerical outcomes in the way a clinical study would for diagnostics. Instead, it describes categories of testing and the general outcome that "All testing passed and the demonstrated product performance met all prior established acceptance criteria." The acceptance criteria are implicitly tied to the performance specifications of the predicate device and relevant industry standards.

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

The document refers to "verification and validation testing" including "device performance testing," "safety and compatibility testing," and "reliability testing." These are typically engineering tests.

• Sample Size: The specific sample sizes for these engineering tests (e.g., number of injection cycles, number of units tested) are not stated in the provided 510(k) summary. These details would typically be found in the full test reports submitted to the FDA, not in the summary.
• Data Provenance: This is not a clinical study in the typical sense; the data provenance refers to internal engineering test results. The document does not specify a country of origin for the data (it's presumed to be from the manufacturer's testing facilities). The tests are prospective in the sense that they were designed and executed to validate the modified device.

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

This concept (experts establishing ground truth for a test set) is generally applicable to AI/ML or diagnostic image analysis studies. For a device like an angiographic injector, "ground truth" is established by engineering specifications, calibration standards, and adherence to recognized safety and performance standards. No experts for "ground truth" establishment in the context of clinical interpretation or diagnosis are mentioned or relevant here.

4. Adjudication Method for the Test Set

Not applicable for engineering and performance validation of a mechanical/software device like an injector. Adjudication methods (e.g., 2+1, 3+1) are for human interpretation of data, typically in diagnostic studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is relevant for evaluating the impact of a diagnostic aid (e.g., AI) on human reader performance. This device is an angiographic injector system, not a diagnostic aid. The documentation explicitly states: "No clinical testing was required or performed to support this Special 510(k) Premarket Notification."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done

This question is typically for AI/ML diagnostic algorithms. While the device has software components (e.g., P3T, ISI, Connect.CT), their "performance" is about controlling mechanical injection parameters or facilitating interface, not interpreting medical data in a standalone diagnostic capacity. The engineering tests implicitly evaluate the "standalone" performance of the system functions against their specifications.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Engineering Specifications: Pre-defined ranges and tolerances for parameters like flow rate, volume, pressure, fill speed, etc.
• Industry Standards: Compliance with standards like IEC 60601-1 (medical electrical equipment safety), EMC requirements, and EN 62366-1:2015 (human factors).
• Predicate Device Performance: The underlying assumption is that the modified device must perform equivalently to the predicate device, which itself met established safety and performance criteria.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML model that requires a "training set." The development of the device involved traditional engineering design and iterative testing, not machine learning.

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

As explained above, this is not an AI/ML device, so there is no "training set" or corresponding ground truth establishment process in that context.

Ask a specific question about this device

MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation: The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.
MEDRAD® Stellant FLEX Syringe Kits: The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.
MEDRAD® Stellant CT Injection System with Certegra Workstation: The MEDRAD® Stellant CT Injection System with Certegra Workstation is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.
MEDRAD® Stellant Syringe Kits: The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors.
MEDRAD® Stellant Connector Tubing: The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors.
P3T Cardiac: P3T Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta.
P3T PA: P3T PA is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta.
P3T Abdomen: P3T Abdomen is indicated for use with CT imaging of abdominal organs (i.e., liver, pancreas, kidneys).
ISI: The ISI module option is indicated for the specific purpose of allowing an injector to interface with a CT scanner.
Connect.CT: The Connect. CT application is indicated for the specific purpose of allowing the injector to interface with a CT scanner.

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation: The MEDRAD Stellant FLEX CT Injection System with Certegra Workstation is a software-controlled medical device used for the administration of intravenous CT contrast media and saline into the human vascular system for diagnostic studies in Computed Tomography (CT) procedures. 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.
MEDRAD Stellant CT Injection System with Certegra Workstation: The MEDRAD Stellant CT Injection System with Certegra Workstation is a software-controlled medical device used for the administration of intravenous CT contrast media and saline into the human vascular system for diagnostic studies in Computed Tomography (CT) procedures. Commonly referred to as an automated injection svstem, it is designed to allow a user to fill disposable svringes to perform an injection with a user-programmed volume, flow rate and/or duration.
Personalized Patient Protocol Technology (P3T): The Stellant P3T software accessories compute individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration for individualized dosing, and for increasing the consistency of individualized injection protocols among clinicians.
Imaging System Interface (ISI): The ISI module options allow an injector to interface with a CT scanner.
Connect.CT: The Connect.CT application allows an injector to interface with a CT scanner.

The provided document is a 510(k) premarket notification for a medical device: the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation and associated components. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as for a PMA. Therefore, the device performance is evaluated against established engineering specifications and verified through various forms of bench testing, rather than clinical efficacy measures.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria in a quantitative, pass/fail table format directly tied to an AI or algorithm's performance. Instead, it discusses the general performance requirements and outcomes of various engineering tests. The "reported device performance" is consistently stated as "All testing passed and the demonstrated product performance met all prior established acceptance criteria."

General categories of acceptance criteria (implicit from testing performed) and reported outcomes:

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

The document describes various bench tests and simulated use tests rather than studies involving patient data or clinical test sets in the context of an AI/algorithm. Therefore, information regarding "sample size used for the test set" and "data provenance (e.g., country of origin of the data, retrospective or prospective)" is not applicable in the way it would be for AI/algorithm performance studies.

The testing involved:

• Bench testing: Performed on design changes unique to the proposed devices and on shared elements, leveraging existing data from predicate devices. Specific sample sizes for mechanical tests (e.g., number of syringes tested for pressure) are not detailed but are implied to be sufficient for engineering verification.
• Aged samples and samples subjected to shipping conditions were used for disposables performance testing.
• Biocompatibility testing was done on the Kits and Tubing.

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

Given that this is a 510(k) submission for an injection system and accessories, relying on demonstrating substantial equivalence through engineering and simulated use testing, the concept of "ground truth" established by human experts (like radiologists for image analysis) is not directly applicable in the typical sense for AI/algorithm evaluation.

The "ground truth" for the performance tests would be the established engineering specifications and safety requirements, which are set by scientific and regulatory standards (e.g., ISO, IEC, ASTM) and internal design requirements. Human factors testing involved "simulated clinical environment" and validated "clinical user needs," implying input from clinical professionals, but specific numbers or qualifications are not provided.

4. Adjudication Method for the Test Set

Since there is no "test set" in the context of human interpretation of medical data, an "adjudication method" (like 2+1 or 3+1 for resolving disagreements) is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "No clinical testing was required or performed to support this Traditional 510(k) Premarket Notification." Therefore, an MRMC comparative effectiveness study was not done. The device is not an AI/algorithm where human reader improvement with assistance would be measured.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device (an angiographic injector and its accessories) is a hardware and software system used with a human operator, not a standalone algorithm for diagnosis or image analysis. The "P3T software accessories compute individual contrast injection protocols and scan timing," which can be considered an algorithmic component, but its performance is verified as part of the overall system's functional design and accuracy in delivering specified parameters, not as a standalone diagnostic algorithm. The testing confirms that this software functions correctly within the system.

7. The Type of Ground Truth Used

The ground truth for this device's performance evaluation is based on:

• Engineering specifications and design requirements: These define the expected performance parameters (e.g., flow rate range, volume range, pressure limits, sterilization level).
• International standards and regulations: Such as ISO 594, ISO 11607-1, ISO 10993-1:2009, ISO 11137-1, IEC 60601-1, ASTM D4169, EN 62366-1:2015, and FDA Guidances. These standards establish acceptable performance thresholds for medical devices, particularly regarding safety, biocompatibility, and functionality.

8. The Sample Size for the Training Set

As this is a hardware medical device with supporting software for controlling injections, and not an AI/ML algorithm that requires a "training set" of data to learn from, this concept is not applicable.

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

Since there is no training set in the context of AI/ML, the question of how its ground truth was established is not applicable. The device's "P3T software" calculates injection protocols based on "patient characteristics, scanner parameters and contrast concentration," which are pre-defined inputs and rules, not learned from a training set.

Ask a specific question about this device