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The MEDRAD® Imaging Bulk Package Transfer Spike (Transfer Spike) is indicated for the transfer of Gadavist® (gadobutrol) injection contrast media as supplied in an approved Imaging Bulk package presentation (30 mL or 65mL) to empty, sterile hand syringes and/or empty, sterile syringes on single-use only syringe-based contrast power injection systems indicated for the controlled, automatic venous administration of contrast agents for MR procedures.

The Transfer Spike is to be discarded after one of the following conditions has occurred first: the contrast media container has been depleted, the Transfer Spike has been disconnected from the contrast vial, or after 24 hours has elapsed since the container was penetrated.

The MEDRAD® Imaging Bulk Package Transfer Spike (Transfer Spike) is a pre-administration filling device that is designed to transfer fluid from an imaging bulk package into multiple sterile syringes via a powered injector system prior to an MR procedure. There is no direct patient contact with the use of this device. It is intended to spike one bulk package of Gadavist® (gadobutrol) injection contrast media only. Each imaging bulk transfer set consists of a spike and a swabbable valve. The transfer spike is provided sterile, individually packaged, and is not intended to be resterilized.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MEDRAD® Imaging Bulk Package Transfer Spike:

The document is a 510(k) Premarket Notification from the FDA for the MEDRAD® Imaging Bulk Package Transfer Spike. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials. Therefore, the "studies" are primarily bench and verification tests to show compliance with standards and functional specifications.

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly present a dedicated "acceptance criteria" table with specific quantitative thresholds. Instead, it lists various performance tests and states that "All testing passed" or "Verification results indicate that the Transfer Spike complies with the standards" or "Verification results indicate that the Transfer Spike complies with its predetermined specifications."

Here's a table summarizing the tests performed and the reported outcomes, essentially inferring the acceptance criteria as "compliance with the standard" or "meeting predetermined specifications":

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

The document does not specify general "sample sizes" for the test sets in a clinical study sense, as the testing described is primarily bench validation. For validation tests like sterilization, shelf-life, packaging, and biocompatibility, sample sizes would be determined by the relevant ISO standards and internal validation protocols, but these specifics are not provided in the summary.

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for compliance with the cited ISO standards and internal protocols.
• Data Provenance: The studies are prospective bench and laboratory testing conducted by or for Bayer Medical Care Inc. The location of the test facilities is not explicitly stated beyond Bayer's address in Indianola, Pennsylvania, USA.

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)

This information is not applicable to this submission. The device is a medical accessory (transfer spike) and the studies are technical engineering verifications (sterilization, shelf-life, biocompatibility, etc.), not diagnostic or treatment efficacy studies that would require expert consensus for ground truth. The "ground truth" is established by adherence to recognized national and international standards.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert readers interpret medical images or data to establish a consensus ground truth. The tests performed for this device are objective measurements and validations against predefined technical standards, not subjective interpretations.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is not an AI algorithm or an imaging device that would involve human readers or AI assistance.

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 mechanical accessory, not an algorithm.

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

The "ground truth" for the various tests performed is the compliance with established national and international standards and predetermined specifications for medical devices and their components. Examples include:

• ISO 11137-1, 11137-2, 11137-3 for sterilization.
• ISO 11607-1 and ISO 11607-2 for packaging.
• ISO 10993-1:2018 for biocompatibility.
• ISO 80369-7 and ISO 8536-4:2010 for bench performance.
• **USP ** for injectable particulate matter.
• Approved release specifications for chemical compatibility with Gadavist.

These standards and specifications are the "ground truth" against which the device's technical performance is measured.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this device is not an AI algorithm.

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

This information is not applicable as there is no training set for this device.

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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.

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The MEDRAD® Mark 7 Arterion Injection System is indicated to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

Imaging System Interface (ISI)

The ISI option is indicated for the specific purpose of allowing a MEDRAD® Mark 7 Arterion Injection System to interface with an angiography imaging system.

The MEDRAD Mark 7 Arterion Iniector is a software-controlled medical device used to inject contrast agents from a 150 ml disposable syringe. Commonly referred to as an automated injection system, it is designed to allow a user to fill a disposable syringe and perform an injection with a user programmed volume and flow rate.

Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the MEDRAD Mark 7 Arterion Injection System:

It's important to note that this 510(k) submission is for an administrative update to include an Imaging System Interface (ISI) module in the Indications for Use. Therefore, the information related to comprehensive acceptance criteria and standalone performance studies for the core injection system itself is not present in this document, as it refers back to previous 510(k) clearances.

Acceptance Criteria and Reported Device Performance

Given that this 510(k) is an administrative update and points to a previously cleared predicate device (K132928) for performance, there are no new acceptance criteria or reported device performance metrics specifically established or tested for this submission. The document explicitly states:

"Verification testing was not necessary to demonstrate that the modified indication for use remains safe and effective. Performance testing performed with MEDRAD Mark 7 Arterion Injection System which was provided in previous 510(k)s remains applicable."

However, the comparison table (Table 1) provides the specifications of the device, which can be seen as the operational parameters that the device is designed to meet.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable/Not provided in this document. This submission is an administrative update and did not involve new performance testing. It refers to previous 510(k)s for performance data.
   • Data Provenance: Not applicable/Not provided in this document.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This submission is for an administrative update and did not involve clinical or performance studies requiring expert-established ground truth.

3. Adjudication method for the test set:

   • Not applicable. No new test set was evaluated for this submission.

4. 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 MRMC study was done or is relevant. This device is an angiographic injector, not an AI-assisted diagnostic or decision support system. The update is purely administrative to expand the indications for use of the ISI module.

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

   • No standalone algorithm performance study was done or is relevant for this submission. The device is a hardware/software system for injecting contrast media, not an AI algorithm.

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

   • Not applicable to this administrative update. Performance data for the core device relies on engineering and functional testing, not diagnostic ground truth.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set in the conventional sense. The software in the injector is control software, not a learning algorithm.

8. How the ground truth for the training set was established:

   • Not applicable. No training set was used.

Summary of Device and Submission Type:

This 510(k) (K193028) is a Special 510(k) Premarket Notification for an administrative update to the MEDRAD Mark 7 Arterion Injection System. The core device functions and performance are unchanged from its predicate (K132928). The modification solely adds the "Imaging System Interface (ISI) option" to the Indications for Use, allowing the injector to interface with angiography imaging systems. Because the changes are administrative and do not impact the fundamental scientific technology, principle of operation, or introduce new issues of safety and effectiveness, no new performance testing, clinical testing, or studies described in your prompt (e.g., MRMC, standalone algorithm performance, expert ground truth, training/test sets) were required for this specific submission. The FDA's clearance is based on the substantial equivalence to the predicate device, including its previously demonstrated performance.

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The MEDRAD® MRXperion MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic resonance imaging (MR) applications with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. Only trained healthcare professionals are intended to operate this device.

The MEDRAD MRXperion MR Injection System is a software-controlled medical device used for the administration of intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) procedures. Commonly referred to as an automated injection system, it is designed to allow a user to fill disposable syringes and then to perform an injection with a userprogrammed volume and flow rate.

This document describes a 510(k) premarket notification for the MEDRAD MRXperion MR Injection System, which is an angiographic injector and syringe system. The submission is for a new control room unit (CRU) with integrated hardware components as an alternative to the existing CRU.

The document does not contain information related to an AI/ML powered medical device, therefore it does not provide the details required to answer questions 1-9 regarding acceptance criteria and study data for such a device. The device is a traditional medical device (an injection system) and the performance data described relates to its physical and functional attributes.

Here's a breakdown of what the document does provide and why it can't answer the specific questions about AI/ML acceptance criteria and studies:

What the document tells us about the device and its assessment:

• Device Name: MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
• Regulation Number & Name: 21 CFR 870.1650, Angiographic Injector And Syringe
• Regulatory Class: Class II
• Product Code: DXT
• Predicate Device: MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit, K143538
• Changes from Predicate: A new control room unit (CRU) with integrated hardware components. The changes are described as "aesthetic improvement, modular design and serviceability." The document explicitly states: "The fundamental scientific technology, principle of operation, and indications for use are unchanged from the predicate device... The differences... do not introduce new issues of safety and effectiveness and do not change the indications for use or result in a different fundamental scientific technology."
• Performance Data (General): Verification and validation testing was conducted. This included:
  • Device performance testing (fluid delivery, flow rates, volumes, pressures).
  • Safety and Compatibility testing (configurations, circuitry, IEC 60601-1, EMC, electrical safety controls, failure detection, programming keys, sensors, safe operation).
  • Reliability testing (sequential and repeated performance, simultaneous operation with Informatics processes).
  • Simulated Use and Human Factors testing (per EN 62366-1: 2015 and FDA Guidance).
  • Cleaning and disinfection validation (per FDA Guidance "Reprocessing Medical Devices in Health Care Settings").
• Key Finding: "All testing passed and the demonstrated product performance met all prior established acceptance criteria." "All test results demonstrate that the design and materials... meet the established performance criteria and will perform as intended." "The results of the design verification and validation, including human factors engineering evaluation, demonstrate that the subject device is substantially equivalent to its predicate device."
• Clinical Testing: "No clinical testing was required or performed to support this Special 510(k) Premarket Notification." This is common for special 510(k)s where the design changes do not raise new questions of safety or effectiveness.

Why the requested information (1-9) cannot be extracted from this document:

The provided document is a 510(k) summary for a non-AI/ML medical device. The acceptance criteria and study design questions (specifically regarding sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are standard requirements for AI/ML-powered medical devices. This document verifies the substantial equivalence of a physical medical injection system that has undergone minor design changes (specifically, the control room unit).

Therefore, I cannot provide answers to the specific questions regarding AI/ML device acceptance criteria and study details because the document is not about an AI/ML device.

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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.

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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.

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The MEDRAD® MRXperion MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. Only trained healthcare professionals are intended to operate this device.

The MEDRAD MRXperion MR Injection System is a software-controlled medical device used for the administration of intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) procedures. Commonly referred to as an automated injection system, it is designed to allow a user to fill disposable syringes and then to perform an injection with a user-programmed volume and flow rate.

The MEDRAD MRXperion MR Injector consists of two basic modules: a Scan Room Unit (SRU) and a Control Room Unit (CRU).

The SRU is comprised of an integral injector head, base assembly, pedestal, and a power supply.

• The injector head of the SRU physically performs the injection. .
• . The base assembly functions as the interface between the CRU, the injector head, and the SRU power supply.
• . The injector head and base are located on a pedestal is designed with locking casters to allow the SRU to be moved when not connected to a patient.
• . To power the base assembly, power is received from the AC mains and is converted to DC voltage by the SRU power supply.

The CRU consists of an All-in-One Computer (AlOC), pod, their dedicated power supplies, mechanical stand, and an optional hand switch.

• The AIOC provides a platform for the graphical user interface for the injector as well as ● the optional informatics applications. From the AIOC, an operator can use the touchscreen display to manage protocols, arm and disarm the injector, review injection realtime progress/feedback and history, access eGFR and patient Weight-Based Dosing calculators, and set system configuration options. The operator can also use the features of the optional informatics device from the AIOC.
• The pod provides injection start and stop functionality and contains the safety controls . for the CRU.
• . To power the AIOC and pod, each component receives AC mains power from its own dedicated off-the-shelf power supply.
• The AIOC and pod are mounted on a desk top mechanical stand.
• . An optional hand switch gives the operator an additional means to start, hold, and stop an injection from the Control Room. The hand switch contains a light that identifies the state of the injector.

The provided document describes the MEDRAD MRXperion MR Injection System and its associated syringe kit. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All testing passed and the demonstrated product performance met all prior established acceptance criteria." However, specific numerical acceptance criteria for each test are not explicitly detailed in the provided text. Instead, it lists the types of tests performed and confirms they met their objectives.

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

The document does not explicitly state numerical sample sizes for most of the individual tests. It uses general statements like "testing was performed."

• Sample Size: Not specified quantitatively for most tests.
• Data Provenance: The testing was conducted by the manufacturer, Bayer Medical Care, Inc. The data is retrospective in the sense that the studies were completed to support the 510(k) submission, but it's not data from clinical practice. The country of origin for the data is not specified, but the manufacturer is based in the USA.

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

This information is not provided in the document. The testing described is non-clinical bench testing, not a study requiring expert-established ground truth in the context of diagnostic interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the described testing is non-clinical bench and performance testing, not a study involving human interpretation or adjudication.

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. The device is an MR injection system, not an AI diagnostic tool.
• This section is not applicable to the device described.

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. The device is a physical injection system with software control, not a standalone diagnostic algorithm.
• This section is not applicable to the device described.

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

For the non-clinical testing, the "ground truth" was established by engineering and quality standards, specifications, and regulatory requirements (e.g., ISO, ASTM, IEC standards, and internal product specifications). For example:

• Physical measurements (flow rates, pressures, volumes) were compared against defined engineering specifications.
• Biocompatibility was assessed against ISO 10993.
• Sterility was assessed against ISO 11137 standards.
• MRI compatibility was tested against defined performance metrics within specified magnetic field strengths.

8. The sample size for the training set

• Not applicable. This device is an injection system and does not involve AI or machine learning algorithms that require a training set in the conventional sense. The "training" here would refer to the development and iterative testing of the device's hardware and software, rather than training a model on data.

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

• Not applicable. As stated above, there is no AI training set as defined in this context. The "ground truth" for the device's design and engineering would be based on established engineering principles, international standards, and internal product specifications validated through extensive bench testing and simulated use.

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The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

The MEDRAD Mark 7 Arterion Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies.

The MEDRAD Twist & Go Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies.

The MEDRAD Mark 7 Arterion Injector is a software-controlled medical device used to inject contrast agents from a 150 ml disposable syringe. Commonly referred to as an automated injection system, it is designed to allow a user to fill a disposable syringe and perform an injection with a user-programmed volume and flow rate.

For the Mark 7 Arterion Injector System, the MEDRAD VFlow Hand Controller is provided sterile for single patient use only. The hand controller provides the operator the ability to precisely control and instantaneously adjust variable flow rates of contrast during contrast injection and puffing operations.

When the injector is in the variable rate injection mode, the flow rate increases incrementally as the hand controller plunger is depressed, and decreases as the hand controller is released. In the fixed rate injection mode, the hand controller acts as a start switch, and release of the device ceases all flow. The VFlow Hand Controller requires the same amount of force to depress the plunger regardless of the set flow rate, volume, and pressure limit or the viscosity of the delivered contrast media. Additionally, the VFlow Hand Controller allows the clinician to step away from the radiation source during an injection.

The Twist & Go Syringe function is the same as the Mark 7 Arterion Syringe. The syringes are both supplied sterile and are designed to be loaded into the automated injector head from the front of the injector (front loading). The clear polycarbonate material used in both syringes improves visualization of residual air compared to opaque polypropylene. The Twist & Go Syringe enables single-handed attachment of the Twist & Go High Pressure Connector Tubing to the syringe.

Below is a summary of the acceptance criteria and study information for the MEDRAD Mark 7 Arterion Injection System, MEDRAD Mark 7 Arterion Syringe, and MEDRAD Twist & Go Syringe, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining specific numerical acceptance criteria for a new clinical performance study. The "Performance Data" section in the document broadly states that "Bench and laboratory testing were performed to support a determination of substantial equivalence to the predicate devices. Results from the testing provide assurance that the proposed devices conform to the requirements for their intended use."

The tables provided (Tables 1 and 2) compare the features and specifications of the proposed devices against their predicate devices. Since the changes are primarily the addition of a variable flow rate option and a new syringe configuration, the acceptance criteria are implicitly that the new features function as intended and that the core functionalities (shared with the predicate) remain equivalent.

For instance, for the "Variable Flow Rate" feature:

• Acceptance Criteria (Implicit): The variable flow rate should operate within the specified range of 1.0 - 10.0 ml/sec in 0.1 ml/sec increments.
• Reported Device Performance: The proposed device includes a "Variable: 1.0 - 10.0 ml/sec in 0.1 ml/sec increments". This indicates that it meets its own defined specification.

For the syringes:

• Acceptance Criteria (Implicit): The pressure rating should be 1200 psi.
• Reported Device Performance: The proposed MEDRAD Mark 7 Arterion Syringe and MEDRAD Twist & Go Syringe both have a "Pressure rating" of "1200 psi".

Below are the performance-related criteria explicitly mentioned in the comparison tables, and their reported performance, which demonstrates equivalence to the predicate or adherence to new specifications.

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

The document describes "Bench and laboratory testing" and "System level testing with a MEDRAD automated injector (syringe)" but does not specify sample sizes for these tests. The provenance is internal laboratory testing ("Bench and laboratory testing"). It does not appear to be retrospective or prospective in the clinical sense, as it refers to device functionality testing.

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

This information is not provided in the document. Given that the testing detailed is "Bench and laboratory testing" focused on physical and mechanical properties, as well as software functionality, it's unlikely that ground truth in the context of expert medical interpretation (e.g., radiologist consensus) was established for these tests. The term "ground truth" as typically used in medical device AI/ML contexts does not apply here.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided as the tests relate to engineering performance and functional compliance, not subjective interpretations requiring adjudication.

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

An MRMC comparative effectiveness study was not performed or reported. The submission describes a device for injecting contrast agents, not a diagnostic or AI-assisted interpretation tool that would typically involve human readers.

6. Standalone Performance Study:

A standalone performance study (algorithm only performance without human-in-the-loop) was not performed or reported. This device is an injector, not an AI algorithm. The performance testing evaluated the functionality of the device itself (injector and syringes) and its new variable flow rate software.

7. Type of Ground Truth Used:

The "ground truth" for the performance data in this submission would be defined by the engineering specifications and physical measurements from the bench and laboratory tests. For example, testing the pressure rating of the syringe against a known standard (1200 psi), or measuring flow rates and volumes to ensure they match programmed settings. This is distinct from ground truth based on pathology, expert consensus, or outcomes data, which are typically used for diagnostic or AI-powered devices.

8. Sample Size for the Training Set:

This information is not applicable and not provided. The device is an electro-mechanical angiographic injector system, not an AI/ML algorithm that requires a "training set" of data in the conventional sense. The "software-controlled" aspect implies programmed logic and control algorithms, not machine learning or AI models trained on data.

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

This information is not applicable and not provided for the same reasons as #8.

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The Twist & Go High Pressure Connector Tubing is intended to be used in the delivery of contrast media and common flushing solutions. The device is indicated for single use only with MEDRAD injectors.

The MEDRAD Twist & Go High Pressure Connector Tubing is a sterile, single-use only, disposable connector tube that is used to transfer contrast media and common flushing solutions from an automated injector syringe to an administration set during angiographic procedures.

The provided text describes the MEDRAD Twist & Go High Pressure Connector Tubing and its clearance through the FDA 510(k) process. This document is a summary for a medical device (tubing for contrast media delivery) and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than conducting a comprehensive clinical study to prove performance against specific acceptance criteria in the manner one might expect for a diagnostic or therapeutic algorithm.

Therefore, many of the requested elements (e.g., sample size for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, type of ground truth for learning algorithms) are not applicable to this type of device submission as it is not an AI/ML-based algorithm or a diagnostic tool requiring such rigorous evaluation against clinical endpoints.

Instead, the "acceptance criteria" here are largely defined by equivalence to the predicate device and adherence to bench and laboratory testing standards relevant for a fluid delivery tube.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a direct "acceptance criteria" table with numerical targets in the same way an AI/ML study would. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device (MEDRAD High Pressure Connecting Tube K810924) and passing various bench and laboratory tests.

The comparison of features table (page 2) serves as the primary evidence for demonstrating functional equivalence.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in terms of a "test set" for a diagnostic algorithm. The testing described is bench and laboratory testing on device prototypes or production samples. The number of samples for each specific test (e.g., pressure rating, leak testing, material property verification) is not provided in this summary.
• Data Provenance: The data is generated from bench and laboratory testing conducted by MEDRAD, Inc. (Bayer Medical Care, Inc.) in Indianola, PA, USA. There is no mention of country of origin of clinical data, as this is a device component, not a clinical diagnostic. The testing is prospective in the sense that it was conducted specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This submission is for a medical device (connector tubing) and does not involve AI/ML or a diagnostic test where expert-established ground truth would be required. The "ground truth" for a connector tube's performance relies on engineering specifications and physical test results (e.g., pressure resistance, flow rates, biocompatibility).

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

• Not applicable. See point 3.

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/ML device or a diagnostic requiring a reader study.

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

• Not applicable. This is not an AI/ML device. The "standalone performance" refers to the physical and functional performance of the tubing itself when subjected to specified conditions (e.g., pressure, flow). The summary states "System level testing with a MEDRAD automated injector" which implies testing the device in its intended use environment, but this is not an algorithm's standalone performance.

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

• The "ground truth" for this device type is primarily based on engineering specifications, material science standards, and performance test results. For example, pressure rating is verified against a specified mechanical test standard, and biocompatibility is confirmed against ISO standards. There is no pathology or outcomes data mentioned for this type of device component in a 510(k) summary.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm. Device design and development would involve various iterations and testing, but not in the sense of training a machine learning model.

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

• Not applicable. See point 8.

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