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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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