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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 <788> 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® 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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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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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.

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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