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for use during coronary angiography procedures as a connecting line for the injection of radiopaque dye, saline or other diagnostic fluids.

The Disposable High Pressure Injection Lines with and without Rotating Adapters are a combination of connectors and tubing bonded together for injection of radiopaque dye, saline, or other diagnostic fluids during a coronary angiography procedure. The device is designed, like other legally marketed devices, for one end to connect to the fluid source (such as an angiographic syringe) and the other end to connect to the catheter. The contrast, saline, or other diagnostic fluid is then injected from the syringe, through the high pressure line, into the catheter. The materials and properties of the device are tabled in Item 6, below.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document is a 510(k) premarket notification for a medical device (Disposable High Pressure Injection Lines with and without Rotating Adapters). The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to conduct a comprehensive study on a new or innovative technology. Therefore, many of the typical acceptance criteria and study characteristics you'd expect for AI/software-as-a-medical-device (SaMD) are not applicable here.

Device: Coeur Medical, a division of Coeur, Inc. Disposable High Pressure Injection Lines with and without Rotating Adapters

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the primary difference is the manufacturer assembling components and sterilizing the devices, and that the proposed devices will offer a "more flexible device that meets the needs of the high pressure market." However, quantitative metrics for "flexibility" or how it "meets the needs" beyond the pressure rating are not provided as acceptance criteria or performance metrics directly in this summary.

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

• Sample Size: Not explicitly stated as a number of units. The document mentions "pressure testing was conducted at 1200psi to verify acceptable performance of the 'worst case' challenge," implying at least one or more units were tested.
• Data Provenance: Not applicable. These are nonclinical (bench) tests for a physical medical device, not data from patients or medical imaging.

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

• Not applicable. This relates to nonclinical physical testing, not expert-based ground truth for diagnostic accuracy.

4. Adjudication method for the test set

• Not applicable. This relates to nonclinical physical testing, not expert review or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

• No. This is a 510(k) premarket notification for a physical medical device, not an AI/SaMD product. MRMC studies are not relevant here.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• Bench test results/Engineering specifications: The "ground truth" for the device's performance is against its own design specifications and functional requirements (e.g., ability to withstand 1200psi without failure, achieving a specific SAL).

8. The sample size for the training set

• Not applicable. There is no "training set" for this physical device.

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

• Not applicable. There is no "training set" for this physical device.

Summary of the Study:

The "study" described in the 510(k) summary is based on nonclinical tests to verify the functional performance of the Disposable High Pressure Injection Lines.

• Nonclinical Tests Submitted: "Verification of functional performance has been performed."
  • Pressure Testing: Conducted at 1200psi to verify acceptable performance, as this is the greatest pressure for which the device is developed ("worst case" challenge).
  • Sterilization Cycle Verification: The Coeur sterilization cycle is stated to be able to sterilize the proposed device with an SAL of 10⁻⁶, based on a comparison to products tested for inclusion in the Coeur cycle. This implies a validation of the sterilization process itself.
• Clinical Tests Submitted: "NA" (None)
• Conclusions: The testing verifies that the proposed devices are suitable for their intended use. The primary basis for substantial equivalence is that the device has similar technological characteristics (materials, intended use, sterilization method, components, pressure rating) to legally marketed predicate devices, and the nonclinical testing demonstrates equivalent performance where applicable.

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Conduit tubing to deliver fluids from an electronic or manual injector; connector tubing to provide a sterile fluid pathway between two devices.

The High Pressure Line is a device used as conduit tubing to deliver fluids from an electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices. The device consists of plastic tubing with plastic luer lock connector hubs at each end. The luer lock connector hubs are a female/male combination or a female/rotating male combination. The device is available in lengths of 10 to 48 inches and supplied as a sterile, disposable single put up in sealed pouches, in non-sterile bulk quantities, or included as a component in catheter introducer kits,trays, or packs.

The provided 510(k) summary for the "High Pressure Injection Line" (K963749) does not contain the detailed information requested regarding acceptance criteria and a specific study proving the device meets those criteria, as typically seen for AI/ML or diagnostic devices. This is because K963749 is for a medical device (tubing) and not an AI-powered diagnostic tool. The regulatory requirements and testing methodologies are fundamentally different.

However, I can extract the information that is present and highlight the differences:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of "Implied" Criteria: The 510(k) process for this type of device relies heavily on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are implicitly tied to the predicate device's established safety and performance, and demonstrating that the new device meets or exceeds those attributes.

Regarding the other requested information, the 510(k) summary for K963749 does not contain the following details, as they are largely irrelevant for a non-AI/ML medical device like a high-pressure injection line:

• Sample size used for the test set and the data provenance: Not applicable. The "test set" here would refer to the physical units of the device tested, not a dataset for an algorithm.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context would generally be objective measurements of material properties and performance, not expert interpretations.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable. MRMC studies are for evaluating diagnostic accuracy with human readers.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
• The type of ground truth used: For this device, "ground truth" would be established by validated laboratory equipment and standardized testing protocols (e.g., measuring burst pressure, tensile strength, biocompatibility assays).
• The sample size for the training set: Not applicable. There is no training set as it's not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

Summary of the Study (Implied):

The "study" referenced in the 510(k) to prove the device meets acceptance criteria is a series of bench tests and biocompatibility assessments designed to demonstrate that the Maxxim Medical High Pressure Injection Line is substantially equivalent to its predicate device (Advance High Pressure Lines; K911884).

Specifically, the document states:

• "Biocompatibility of the device has been established by cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity and hemocompa-tibility tests."
• "The device meets the requirements of the USP XXIII physico-chemical tests for plastics."
• "Results of simulated use tests, pull tests and static pressure tests indicate that the High Pressure Injection Line has performance characteristics equivalent to or better than those of the predicate device."

These tests are the "proof" that the device is safe and effective for its intended use, by demonstrating it performs comparably or better than an already legally marketed device with a similar design and function. The 510(k) process for such devices focuses on demonstrating this substantial equivalence rather than establishing novel clinical efficacy.

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