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The CT Expres™ 3D Contrast Media Delivery System is indicated for controlled automatic administration, on the venous side, of contrast media and saline, to human subjects while undergoing examination by means of a computed tomography (CT) scanner.

The CT Expres™ 3D Contrast Media Delivery System is specifically indicated for use in CT procedures for the delivery of Isovue (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum of 20 bottles of contrast media or a maximum of ten (10) hours, whichever comes first, per Day Set III HP disposable. The Bottle Spike disposable is for single-bottle use only and must be discarded with the contrast media bottle. The Patient Set disposable must be discarded after each patient procedure.

The CT Expres™ 3D is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.

The CT Exprès™ 3D Contrast Media Delivery System (CT Exprès™ 3D) is designed for the controlled, automatic administration, on the venous side, of water-soluble radiographic medical imaging products for contrast enhancement of computed tomography (CECT) imaging. The positive pressure necessary for the injection is generated by a rotary peristaltic pump that is part of the disposable Patient Set. The system is designed to protect the patient against air injection and occlusion by incorporating sensors to detect air and pressure within the fluid pathway.

The system consisting of the CT Exprès™ 3D injector unit, main and remote control panels, hand switch, bottle insulators, floor stand and disposables (Bottle Spike Type B, Day Set III HP, Patient Set), is specifically designed for the delivery of Isovue® (Iopamidol Injection) contrast media and saline. The Isovue is supplied for use in the CT Exprès™ 3D System as an Imaging Bulk Package (IBP), for a maximum of 20 bottles of contrast media per Day Set III HP disposable or 10 hours, whichever comes first.

The CT Exprès™ 3D Contrast Media Delivery System is a combination product. As stated above, the CT Exprès™ 3D is specifically indicated for use in CT procedures for the delivery of Isovue (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), (submitted in the supplemental New Drug Application sNDA to the Isovue NDA 20-327 (S011)).

The provided text describes a medical device, the CT Exprès 3D Contrast Media Delivery System, and its substantial equivalence to a predicate device (CT Exprès III) based on non-clinical performance testing. It does not contain information about acceptance criteria and device performance in the context of an AI/ML-driven medical device study. Therefore, I cannot fulfill your request for that specific information from this document.

However, I can extract information related to the device itself and the non-clinical testing performed, which serves a similar purpose to acceptance criteria in the context of device validation.

Here's an attempt to structure the information based on your request, as much as possible with the provided text:

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

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of an AI/ML study. Instead, it details design verification and validation testing for the CT Exprès™ 3D Contrast Media Delivery System and compares it to a predicate device. The performance values listed are implicitly the accepted performance for the device.

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 primarily describes non-clinical performance testing and simulated use usability validation. It does not mention a "test set" in the context of an AI/ML study, nor does it specify sample sizes for data used in such a context. The testing appears to be primarily laboratory-based or simulated.

• Non-clinical performance testing: No specific sample sizes for tests like electrical safety, reliability, flow rate accuracy, etc., are provided, other than the general statement that they were performed to demonstrate conformance.
• Simulated use usability validation: This involved "users" but no specific number of participants or data provenance information is given.

The document is a 510(k) submission to the FDA (USA), implying the evaluation occurred within a regulatory framework applicable to the US market. The manufacturer is Bracco Injeneering S.A., based in Switzerland. The data provenance for the non-clinical testing and simulated use is not explicitly stated beyond these general facts. The testing conducted would be considered prospective for the device under review.

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 as the document describes a medical device, a contrast media delivery system, not an AI/ML algorithm that requires expert ground truth labeling in the way a diagnostic AI would. The "ground truth" for this device would be established through engineering specifications, physical measurements, and adherence to medical device standards.

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

This information is not applicable for the reasons stated above.

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

This information is not applicable as the document describes a contrast media delivery system, not an AI/ML diagnostic or assistive device that would involve human readers interpreting output with or without AI assistance.

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

This information is not applicable as the document describes a physical medical device, not an algorithm.

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

For the reported non-clinical performance and simulated use testing, the "ground truth" would be established by:

• Engineering specifications and standards: For characteristics like electrical safety, electromagnetic compatibility, dimensions, weight, power requirements.
• Physical measurements and laboratory testing: For accuracy of injection volume, flow rate, air detection limits, occlusion detection limits, tubing dimensions.
• Biocompatibility standards: For disposable materials.
• Validated testing protocols: For sterilization, aging, packaging, transportation, microbial ingress, cross-contamination, chemical compatibility.
• Usability assessments: For "users can operate the CT Exprès™ 3D as safely and as effectively as the predicate device" through observation and feedback in a simulated environment.

There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the performance characteristics measured or validated in this submission.

8. The sample size for the training set

This information is not applicable as the document describes a deterministic medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the reasons stated above.

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The Bracco Injeneering Transfer Set is a component of a contrast management system and is indicated for the transfer of Isovue (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package to empty sterile syringe-based contrast injection systems included automatic administration on the venous side, of contrast agents for CT procedures. The Transfer Set is to be discarded after the contrast media container has been deplected or 10 hours has elapsed since the container was penetrated, whichever occurs first.

The Bracco Injeneering (BINJ) Transfer Set is a sterile tubing set for connection between an imaging bulk package and empty sterile syringes on single-use-only, syringe based contrast delivery systems (injectors). The BINJ Transfer Set is approximately 20 inches long, and its components are made with medical grade materials. The BINJ Transfer Set is supplied ethylene oxide (EtO) sterilized to a Sterility Assurance Level (SAL) of 10-6, and is individually packaged. At the time of this submission, accelerated aging tests confirm a one (1) year shelf life. The BINJ Transfer Set is disposable, and is to be discarded after the contrast media container has been depleted, or 10 hours has elapsed since the container was spiked.

This document is a 510(k) Summary for the Bracco Injeneering Transfer Set, indicating substantial equivalence to a predicate device. It primarily details the device's intended use, technological characteristics, and performance testing related to safety and manufacturing standards, rather than providing a study comparing device performance against specific clinical acceptance criteria in terms of diagnostic accuracy or reader improvement.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily related to safety, sterility, shelf-life, and material compatibility, demonstrating that the device meets established medical device standards. No specific performance metrics like sensitivity, specificity, or accuracy (as one might find for an AI diagnostic device) are provided, as this is a medical device for fluid transfer, not a diagnostic tool.

• ISO 594-2: 1998, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment – Part 2: Lock fittings
• ISO 8536-4: 2010, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed.
• Microbial ingress testing
• Chemical compatibility, leachable compounds, and particulates testing. | Test and verification results indicate that the BINJ Transfer Set complies with its predetermined specifications and the standards. |
  | Substantial Equivalence (Overall) | Demonstrated equivalence to predicate device (E-Z-EM, Inc. Empower Transfer Set, K041178) in intended use, indications for use, and technological characteristics. | The BINJ Transfer Set is considered substantially equivalent to the predicate device, being safe and effective when used in accordance with its intended use and labeling. |

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

The document does not specify a "test set" in the context of diagnostic accuracy, as this is a device for fluid transfer. The testing described (sterilization, shelf-life, biocompatibility, and bench performance) involves specific samples of the device and its components, but the sample sizes for these engineering tests are not explicitly stated. The data provenance is internal testing conducted by Bracco Injeneering S.A.

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

This information is not applicable. The device is a transfer set, and the "ground truth" for its performance is assessed through compliance with engineering and safety standards, not through expert consensus on diagnostic interpretations.

4. Adjudication method for the test set

This information is not applicable for the reasons stated above.

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 such study was conducted or is relevant for this type of medical device (a fluid transfer set). This is not an AI diagnostic or assistive device.

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

This information is not applicable. The device is a physical medical component, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is adherence to established international and national standards for medical devices, including:

• Sterility: Sterility Assurance Level (SAL) of 10-6 per ISO 11135-1.
• Packet integrity and Shelf-life: Compliance with ISO 11607-1 and ISO 11607-2, and confirmed 1-year shelf life via accelerated aging.
• Biocompatibility: Compliance with ISO 10993-1.
• Functional Performance: Compliance with IEC 62366, ISO 594-2, ISO 8536-4, and specific testing for microbial ingress, chemical compatibility, leachable compounds, and particulates.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of device development for a fluid transfer set.

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

This information is not applicable for the reasons stated above.

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