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ulrichINJECT CT motion is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in computed tomography (CT) applications.

ulrichINJECT CT motion is specifically indicated for use in CT procedures for the delivery of Omnipaque™ (lohexol) Injection, solution - GE Healthcare Inc. contrast media as supplied in Imaging Bulk Packages (IBP).

Pump tubing-flex is used for a maximum time of twenty four (24) hours. When used with Omnipaque™ IBP, a maximum of 19 bottles of contrast media can be used or maximum time of twenty four (24) hours of Pump tubing-flex, or whichever comes first, with a maximum of eight (8) hours per contrast media or saline container.

Spike for CT disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.

ulrichINJECT CT motion is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.

Device Description

ulrichINJECT CT motion is a syringeless contrast media management system that is designed for the controlled, automatic administration, on the venous side, of contrast media and saline, to human subjects undergoing diagnostic examinations in computed tomography (CT) applications.

The ulrichINJECT CT motion system consists of the CT motion terminal, CT motion injector and the CT motion tubing system.

ulrichINJECT CT motion uses a peristaltic pump as part of the injector which is designed to transport the media fluid through the CT motion tubing system (spikes for CT, CT motion pump tubing-flex and patient tubing for pump tubing-flex).

The only component of the ulrichINJECT CT motion that comes in contact with the patient is the ulrichINJECT CT motion tubing system. The tubing system consists of three components:

. Spike for CT
Pump tubing-flex .
. Patient Tubing

The ulrichINJECT CT motion tubing system has indirect contact with the blood path of a patient for a limited duration (few minutes).

The ulrichINJECT CT motion system is also intended to be used with the following components, which are not supplied with the system:

. Multiple patient use saline containers,
. Omnipaque™ IBP contrast media containers, and
. Cannula.

ulrichINJECT CT motion is equipped with multiple hardware and software controls that work together for the intended use of the device. Controls include air detectors, which are designed to detect air without direct contact with the medium, pressure controls to manage and regulate pressure inside the tubing system, and check valves to prevent backflow of media and avoid retrograde contamination.

The ulrichINJECT CT motion is provided in three versions:

Mobile pedestal version
. Ceiling version
Wall mounted version

AI/ML Overview

The document provided is a 510(k) Summary for the ulrichINJECT CT motion device, seeking substantial equivalence to a predicate device. It primarily focuses on comparing the new device to the predicate and listing non-clinical tests conducted to support its safety and performance.

However, the document does not contain the specific information requested regarding acceptance criteria and a structured study demonstrating the device meets those criteria, as typically found in clinical evaluation reports or detailed performance studies for AI/software devices. The ulrichINJECT CT motion is a contrast media management system, a hardware device, not an AI or software device that would typically have the requested metrics (e.g., sensitivity, specificity, F1 score).

Therefore, I cannot fulfill the request for information like:

A table of acceptance criteria and reported device performance (in the context of AI metrics).
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study.
Standalone performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document explicitly states: "No clinical studies were performed using ulrichINJECT CT motion." (Page 18).

Instead, the document details non-clinical testing performed to establish substantial equivalence to a predicate device, as summarized below:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria (Based on Non-Clinical Testing for Substantial Equivalence)

The ulrichINJECT CT motion is a contrast media management system (a hardware device) that was evaluated for substantial equivalence primarily through non-clinical testing. The "acceptance criteria" here refer to compliance with various engineering standards and performance requirements demonstrated through bench testing and material compatibility studies, rather than AI-specific performance metrics. No clinical studies were performed.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (hardware medical device rather than an AI diagnostic tool), the "acceptance criteria" are compliance with established standards and demonstrated functional equivalence to a predicate device. The table below summarizes these and the reported performance.

Category / Standard	Acceptance Criteria (Implied by Compliance)	Reported Device Performance (as stated in document)
General Performance	Conformance with established performance criteria; controlled, automatic administration of contrast media and saline on the venous side. Safe and effective during diagnostic CT examinations.	"ulrichINJECT CT motion system and software were validated in accordance with a Verification & Validation plan to ensure conformance with established performance criteria." It is "indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in computed tomography (CT) applications."
Electromagnetic Compatibility / Electrical Safety	Compliance with IEC 60601-1 and IEC 60601-2.	"Electromagnetic Compatibility / Electrical Safety testing was performed in accordance with... IEC 60601-1... IEC 60601-2..."
Sterilization	Sterility Assurance Level of 10⁻⁶ (SAL 10⁻⁶) in accordance with ISO 11135-1.	"The ulrichINJECT CT motion tubing system is ethylene oxide (EtO) sterilized and was validated to a sterility assurance level of 10⁻⁶ in accordance with... ISO 11135-1... Verification results indicate that the ulrichINJECT CT motion tubing system complies with the standard."
Shelf-Life & Packaging	Packaging integrity and shelf-life validated in accordance with ISO 11607-1.	"ulrich performed real time aging and accelerating aging studies. The ulrichINJECT CT motion tubing system is sterilized and its packaging was validated in accordance with ISO 11607-1... Verification results indicate that the ulrichINJECT CT motion tubing system complies with the standard."
Chemical Compatibility	No interaction with Omnipaque™ (Iohexol) and chemical integrity of Omnipaque™ not compromised.	"material compatibility testing was performed using Omnipaque™ 350 mg//ml as the solvent. The results concluded that the ulrichINJECT CT motion tubing system does not interact with Omnipaque™ and the chemical integrity of Omnipaque™ is not compromised throughout use."
Contamination Control	Maintain sterility of injection media and resist microorganism ingress when used with Omnipaque™ IBP.	"Based on these results, it has been concluded that ulrichINJECT CT motion has the ability to maintain the sterility of the injection media and resist the ingress of microorganisms when used with Omnipaque™ Imaging Bulk Package (IBP) during its intended use." (Studies included process simulation, microbial ingress, cross contamination).
Biocompatibility	Compliance of indirect patient contact materials with ISO 10993-1.	"The ulrichINJECT CT motion tubing system indirect patient contact materials were verified in accordance with... ISO 10993-1... Verification results indicated that the materials comply with the standard."
Performance - Bench	Applicability to ISO 8536-4 (where relevant), capability to deliver contrast media and saline at prescribed rates and volumes for expected cannula ranges, acceptable pressure during operation with various cannulas and flow rates, acceptable levels of extractables and leachables, and successful transport validation.	"ulrichINJECT CT motion tubing system... evaluated the device pressure when using the device with multiple size cannulas at multiple flow rates and to demonstrate that the device is capable of delivering contrast media and saline at the prescribed rate and total volume for the expected range of cannulas." "Additional testing included extractables and simulation testing for leachable compounds and particulates. Transport validation and cleaning instructions validation was performed." "Test and verification results indicate that the ulrichINJECT CT motion tubing system conforms to its predetermined specifications and the applicable standards."
Use within defined disposable time limits	The differing time limits for disposables (Pump tubing-flex, Patient tubing, Spike for CT) compared to the predicate device must be supported by contamination control studies. (Pump tubing-flex: 24hrs; Patient Tubing: 12hrs; Spike for CT: 8hrs)	"The differences in the time limits of the disposables components are addressed through the results of contamination control studies." "The differences in time limits between the ulrichINJECT CT motion and the predicate device are addressed with the completion of contamination control studies."
Human Factors / Usability	Users can operate ulrichINJECT CT motion as the predicate device.	"Human Factors / Usability assessments were performed in a simulated use environment. The results demonstrated that users can operate ulrichINJECT CT motion as the predicate device."
Functional Equivalence to Predicate Device (CT Expres 3D Contrast Media Delivery System)	The ulrichINJECT CT motion should be equivalent in indications for use, overall design, and operating principles to the predicate device, with any differences not raising new questions of safety or effectiveness. Specific parameters like flow rates, volumes, pressure limits, air detection, etc., should be comparable or improved.	The document provides a detailed comparison table (pages 6-7) indicating equivalence or similar performance for numerous parameters (e.g., syringeless system, remote operation, rotary peristaltic pump, administration of contrast/saline, disposable uses spikes, safety stop, volume readout, programmable pressure limit, injection capabilities, injection rates, injection volume, flow rate/volume accuracy, contrast media container volume, saline flush, needle size, injection pause, protocol storage, priming/venting rate, air detection, occlusion detection).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable or not specified within the provided text. The testing conducted was primarily bench testing and simulated use, not clinical trials with human subjects or retrospective/prospective data analysis in the manner typically associated with AI/software performance studies. The provenance of the manufacturing entity is Germany (ulrich GmbH & Co. KG).

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 or not specified as the evaluation did not involve expert-labeled ground truth for a diagnostic task. The "ground truth" for the non-clinical tests was established by compliance with engineering standards and predefined performance specifications.

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

This information is not applicable or not specified because the testing described does not involve human adjudication of results in the context of diagnostic performance.

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. The ulrichINJECT CT motion is a hardware device for administering contrast media, not a diagnostic AI system intended to assist human readers.

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

This information is not applicable as the device is a hardware system, not a standalone algorithm. Its performance is inherent in its electromechanical operation and tubing system.

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

For the non-clinical testing, the "ground truth" was based on:

Compliance with recognized standards: e.g., ISO, IEC standards for sterility, biocompatibility, electrical safety, etc.
Engineering specifications: predefined operational ranges for flow rate, volume accuracy, pressure limits, air detection, etc.
Chemical and microbiological tests: laboratory measurements to confirm material compatibility, absence of contamination, and sterility.

8. The sample size for the training set

This information is not applicable. The ulrichINJECT CT motion is a hardware device and does not involve AI/machine learning training sets.

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

This information is not applicable as there is no training set for an AI/machine learning model.

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