(52 days)
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 Arterion Mark 7 is a software controlled medical device used to inject contrast agents from a 150ml disposable syringe. Commonly referred to as a powered injector it is designed to allow a user to fill a disposable syringe, and perform an injection with a preprogrammed volume and flow rate. The Arterion consists of three basic components or modules: a Power Unit, Display Control Unit (DCU), and an injector head.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "MEDRAD Mark 7 Arterion Injection System."
Important Note: The provided document is a 510(k) summary and an FDA clearance letter. It describes a medical device and its intended use, and indicates that substantial equivalence was demonstrated through bench and laboratory testing. However, it does not contain detailed "acceptance criteria" in the format of specific performance metrics with quantitative thresholds. Similarly, it does not describe a "study" in the sense of a clinical trial or a formal statistical evaluation of performance against clinical outcomes or expert ground truth. Instead, it details engineering tests to ensure safety and functionality.
Based on the provided information, here's what can be extracted and inferred:
Acceptance Criteria and Device Performance (Inferred from Performance Data)
The document does not explicitly state quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, as would be typical for diagnostic AI devices. Instead, the performance data section lists types of bench and laboratory tests performed to demonstrate safety and functionality. The "reported device performance" is implicitly that the device conformed to the requirements for its intended use based on these tests.
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Implied) |
|---|---|
| Pressure Jacket Integrity | Passed "Pressure Jacket Pressure Cycle" testing, indicating its ability to withstand operational pressures over time. |
| Syringe Interface Functionality | Passed "Pressure Jacket Syringe Insert/Remove Cycle" testing, demonstrating reliable engagement and disengagement of syringes. |
| Syringe Durability/High-Pressure Operation | Passed "Syringe High Pressure Life Use Case" testing, confirming the syringes' ability to perform under high-pressure conditions throughout their lifecycle. |
| Disposables General Use | Performed as intended in "Disposables General Use Case" testing, ensuring proper function of disposable components. |
| Drop Front Mechanism Reliability | Passed "Drop Front Engage/Disengage Cycle Test," verifying the robust operation of the drop front cone mechanism. |
| Overall System Functionality | Passed "General Use Case Verification," indicating the system operates as expected during typical usage scenarios. |
| Software Functionality & Safety | Passed "Software Verification/Validation," confirming that the software controls operate correctly and safely according to specifications. |
| Substantial Equivalence to Predicate Device | Concluded to be substantially equivalent to the predicate device based on similarities in functional design, materials, indication for use, fundamental technology, and principles of operation. |
Study Information
Given the nature of the device (an angiographic injector) and the 510(k) summary, the "study" conducted was primarily bench and laboratory testing rather than a clinical trial or an AI performance study against a clinical ground truth.
-
Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not explicitly stated in terms of number of cases/patients. The sample sizes would have been for component cycling (e.g., number of cycles for pressure jackets, syringe insertions/removals, drop front engagements) and simulated use tests.
- Data Provenance: The testing was "bench and laboratory testing," which means it was conducted in a controlled lab environment. There is no mention of country of origin for data as it's not patient data. It was retrospective in the sense that it evaluates the manufactured device against pre-defined specifications, not prospective patient outcomes.
-
Number of experts used to establish the ground truth for the test set and their qualifications:
- Not Applicable. For this type of device (a powered injector), "ground truth" is typically defined by engineering specifications, safety standards, and functional requirements, not by expert consensus on clinical images or diagnoses. Engineers and quality assurance personnel would set these standards.
-
Adjudication method for the test set:
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts when establishing a clinical ground truth, often in image interpretation studies. This device's evaluation relied on objective measurements against engineering specifications.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
- No. This device is an injector, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI enhancement analysis are not relevant or performed for this submission.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, for the software component. The "Software Verification/Validation" would have tested the algorithm's performance in a standalone manner, ensuring it controls the injector's functions (e.g., flow rate, volume) accurately and safely according to its programming. However, this is for operational control, not for a diagnostic output.
-
The type of ground truth used:
- Engineering Specifications and Safety Standards. The "ground truth" was the device's ability to reliably and safely perform its intended mechanical and software functions according to predetermined engineering design specifications and relevant medical device standards.
-
The sample size for the training set:
- Not Applicable. The concept of a "training set" is usually for machine learning algorithms. This device is a mechanical and software-controlled system for fluid injection, not a learning algorithm. Its software is programmed based on engineering principles, not trained on data.
-
How the ground truth for the training set was established:
- Not Applicable. As there is no "training set" in the AI sense, there's no ground truth derivation for it. The operational "truth" for the device's design is dictated by fluid dynamics, mechanical engineering, and safety regulations.
Summary of Device and Evaluation Approach:
The MEDRAD Mark 7 Arterion Injection System is a powered angiographic injector. Its 510(k) clearance was based on demonstrating substantial equivalence to a predicate device (K112086 Mark 7 Arterion Injector System) through robust bench and laboratory testing. This testing focused on ensuring the mechanical integrity, functional reliability, and software correctness of the modified device components (plastic seal, clear plastic cover, software modifications). The evaluation was centered on verifying that the device could safely and effectively perform its intended function of injecting contrast medium, rather than on diagnostic accuracy or AI performance.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.