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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), Omipaque™ (lohexol) Injection, solution - GE Healthcare Inc., and Visipaque™ (lodixanol) Injection, solution - GE Healthcare Inc. contrast media as supplied in single dose bottles.

Pump Tubing-Flex is used for a maximum time of twenty four (24) hours. When used with Omnipaque™ IBP, Omnipaque™ single dose bottles, or Visipaque™ single dose bottles, 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. Time per contrast media or saline container depends on each contrast media's or saline's use time expiration 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.

SYNCopen is indicated for the specific purpose of allowing an injector to interface with a CT scanner.

RIS/PACS is indicated for the specific purpose of allowing an injector to interface with a Radiological Information System (RIS) and a Picture Archiving and Communications System (PACS).

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 intravasular administration of contrast agent.

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. The CT motion tubing system is the only component that comes in contact with the patient and has indirect contact with the blood path of a patient for a limited duration (few minutes). The CT motion tubing system consists of three components:

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

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 ulrichINJECT CT motion system is intended to be used with the following components that are not supplied with the system:

• Multiple patient use saline containers, ●
• . Omnipaque IBP contrast media containers,
• Omnipaque single-dose contrast media bottles. ●
• Visipaque single-dose contrast media bottles, and
• Cannula. .

The ulrichINJECT CT motion system 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), Omnipaque™ (Iohexol) Injection, solution – GE Healthcare Inc., and Visipaque™ (iodixanol) Injection - GE Healthcare Inc. contrast media as supplied in single dose bottles.

ulrichINJECT CT motion is equipped with multiple hardware and software controls that work together for the safe operation of 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 .

The mobile pedestal version consists of the injector head and the injector base with rechargeable battery. The ceiling version and the wall-mounted version consist of the injector head, a fixed-height arm, and a movable arm.

The software option SYNCopen is a new software and hardware option which allows a connection between the injector system and a validated CT scanner. Both systems can communicate with each other and thus synchronize time sequences. The software option is only available if the manufacturer of the CT scanner has enabled the connection to the injector system.

The ulrich medical RIS/PACS Interface is a new software option supports transferring documentation-related parameters for a contrast media injection to healthcare IT systems. A worklist can be retrieved from a RIS server by means of the DICOM modality worklist information model. After selecting a patient from the worklist and performing the iniection, a comprehensive contrast media dose report is automatically transmitted to the configured PACS and/or Dose Reporting system.

The FDA 510(k) Summary for the ulrichINJECT CT motion outlines a series of non-clinical tests to demonstrate that the device meets its performance criteria. While the acceptance criteria are implicitly stated through adherence to various international standards and specific thresholds (e.g., air detection limit, volume accuracy), they are not presented in a single, consolidated table with reported device performance. No clinical studies (MRMC or standalone based on expert consensus/pathology) were performed or referenced for this 510(k) submission, as the submission relies on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's a summary based on the provided text, addressing your specific points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

A consolidated table of acceptance criteria and reported device performance is not explicitly provided in the document. Instead, acceptance criteria are described as conformance to specific international standards and pre-defined thresholds for certain parameters. The reported performance is generally stated as "complies with the standard," "satisfactorily met," or "met the requirements of the pre-defined acceptance criteria."

2. Sample Size for the Test Set and Data Provenance

The document explicitly states that non-clinical testing (bench testing, software verification and validation, EMC testing, sterilization validation, shelf-life studies, chemical compatibility, contamination control, biocompatibility, extractables/leachables, and human factors) was performed.

• No "test set" in the context of clinical images or patient data is mentioned because this is a medical device for contrast media administration, not an imaging AI diagnostic device.
• The tests mentioned are primarily laboratory or simulated use tests. Therefore, there is no direct information on a "sample size for the test set" as would be applicable to an AI diagnostic device evaluating patient data.
• Data Provenance: Not applicable in the context of clinical data. The studies are primarily engineering validation and verification tests.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable. Since this is a submission for a contrast media injector device and not an AI diagnostic tool requiring image interpretation or disease detection, there is no mention of experts establishing a "ground truth" for a test set of patient data. The "ground truth" for the tests performed relates to engineering specifications, safety standards, and functional performance.

4. Adjudication Method for the Test Set

• Not applicable. As there is no "test set" requiring expert interpretation or consensus for clinical ground truth, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. The document does not describe any MRMC comparative effectiveness study. The device is a contrast media injector, and the submission focuses on its technical and functional equivalence and safety, not on improving human reader performance in interpreting medical images.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• Yes, implicitly. All the non-clinical tests described (software validation, EMC, sterilization, shelf-life, chemical compatibility, contamination control, biocompatibility, extractables/leachables, and performance bench tests) are evaluations of the device's inherent functional performance without human intervention in the loop of the test itself. The "Human Factors" study assessed the user interaction with the device, but the core performance criteria were evaluated without human interaction during the test.

7. Type of Ground Truth Used

The "ground truth" for the various non-clinical tests described is based on:

• Technical Specifications: Pre-defined design requirements for flow rate accuracy, volume accuracy, alarm limits (air, occlusion).
• International Standards: Adherence to standards like IEC 60601-1, IEC 60601-1-2, ISO 11135-1, ISO 11607-1, ISO 10993-1, ISO 8536-4.
• Safety and Efficacy Assessments: Demonstrating no adverse interactions with contrast media, maintaining sterility, preventing contamination, and ensuring biocompatibility.
• Usability Objectives: Confirmation that intended users can safely and effectively operate the device.

8. Sample Size for the Training Set

• Not applicable. This submission is for a medical device (contrast media injector), not an AI algorithm that would require a "training set" of data for machine learning. The software mentioned is control software, verified and validated against functional requirements.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As there is no AI algorithm training set, there is no ground truth established for such a set. The "ground truth" for the device's control software functionality would be its design specifications, regulatory requirements, and established safety and performance parameters.

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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 (NaCI), 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), Omnipaque™ (Iohexol) Injection, solution - GE Healthcare Inc., and Visipaque™ (iodixanol) Injection - GE Healthcare Inc. contrast media as supplied in single dose bottles.

Pump tubing-flexis used for a maximum time of twenty four (24) hours. When used with Omnipaque™ IBP, Omnipaque™ single dose bottles, or Visipaque™ single dose bottles, 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. Time per contrast media or saline container depends on each contrast media's or saline's use time expiration 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.

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 underqoing 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. The CT motion tubing system is the only component that comes in contact with the patient and has indirect contact with the blood path of a patient for a limited duration (few minutes). The CT motion tubing system consists of three components:

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

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 updated ulrichINJECT CT motion system is intended to be used with the following components that are not supplied with the system:

• Multiple patient use saline containers, .
• Omnipaque IBP contrast media containers, .
• . Omnipaque single-dose contrast media bottles,
• . Visipaque single-dose contrast media bottles, and
• . Cannula.

The updated ulrichINJECT CT motion system 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), Omnipaque™ (Iohexol) Injection, solution - GE Healthcare Inc., and Visipaque™ (iodixanol) Injection - GE Healthcare Inc. contrast media as supplied in single dose bottles.

ulrichINJECT CT motion is equipped with multiple hardware and software controls that work together for the safe operation of 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 ●

This document describes the ulrichINJECT CT motion, a syringeless contrast media management system for CT applications. The submission to the FDA (K192872) is seeking to market the device as substantially equivalent to a previously cleared version (K171392). The main changes mentioned are the support for additional contrast media (Omnipaque single dose and Visipaque single dose) and a new Li-ion battery option.

Here's an analysis of the acceptance criteria and study information provided:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a clear, concise format. Instead, it details various non-clinical tests performed and states that the device "complies with the standards listed" or "met the requirements of the pre-defined acceptance criteria."

Therefore, I will extrapolate the acceptance criteria and performance based on the described tests and the "Comparison" column in the detailed comparison table, where the subject device is deemed "identical" or "equivalent" to the predicate.

Extrapolated Acceptance Criteria and Reported Device Performance (Based on "Comparison" and "Non-Clinical Testing" sections):

Study Information:

The provided document describes a 510(k) submission (K192872) for the ulrichINJECT CT motion system. This is a premarket notification for a medical device seeking to demonstrate substantial equivalence to a predicate device (K171392), rather than prove de novo safety and effectiveness through extensive clinical trials. Therefore, the "studies" described are primarily non-clinical verification and validation activities.

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

• Test Set Sample Size:

  • For physical components and engineering performance (Flow Rate, Volume Accuracy, Pressure Limits, Air Detection, etc.): The document does not specify a numerical sample size for bench tests. It refers to "verification testing" and "additional verification testing," implying that a sufficient number of tests were conducted to confirm performance parameters against established specifications and standards.
  • For chemical compatibility, contamination control, biocompatibility, and extractables/leachables: These tests typically involve a sample of the device materials and exposure to the specified substances or conditions, but a specific number is not provided.
  • For software validation: No specific number of test cases or iterations is provided, but it states "Validation included an installation qualification and an operational / performance qualification."

• Data Provenance: The studies are non-clinical (bench testing, lab studies). The country of origin of the data is not explicitly stated, but the submitter (ulrich GmbH & Co. KG) is located in Germany. These studies are prospective in the sense that they were conducted specifically for this submission to address the changes and confirm substantial equivalence.

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)

• Not applicable. For this type of non-clinical, engineering, and laboratory-based verification and validation, "ground truth" as established by human experts (like radiologists) is not the primary method. Instead, "ground truth" is typically defined by:
  • Established engineering specifications and performance targets.
  • International and national consensus standards (e.g., ISO, IEC).
  • Regulatory guidance documents (e.g., FDA software guidance).
  • Pre-defined acceptance criteria derived from these specifications and standards.
  • Laboratory analysis results (e.g., chemical assays, microbiological cultures, physical measurements).

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

• Not applicable. Adjudication methods like 2+1 (two readers plus one adjudicator) are used in clinical studies involving human interpretation or subjective assessments. The studies presented here are non-clinical verification and validation tests, where results are typically objectively measured against predefined criteria.

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, an MRMC comparative effectiveness study was not done. This device is an angiographic injector, a hardware-based system for delivering contrast media, not an AI software intended for image interpretation or diagnosis. Therefore, MRMC studies and AI assistance metrics are not relevant to this submission.

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

• Not applicable. This device is a physical injector system with embedded software, not a standalone algorithm or AI software. Its performance is inherent to its mechanical and electronic function, although the software controls are crucial for its operation. The performance described is "algorithm only" in the sense that it's the device's intrinsic mechanical/software behavior being tested, but not an AI algorithm performing a diagnostic task.

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

• The "ground truth" for the non-clinical studies relies on:
  • Engineering specifications and design requirements: For physical dimensions, weights, power, injection rates, volumes, accuracies, and programmable limits.
  • Consensus standards: Such as ISO 11135-1 (sterilization), ISO 11607-1 (packaging), ISO 10993-1 (biocompatibility), IEC 60601-1/60601-1-2 (electrical safety, EMC), and applicable parts of ISO 8536-4 (infusion equipment).
  • Laboratory test results: For chemical compatibility, extractables and leachables (chemical analysis), and contamination control (microbiological assays).
  • Software validation protocols: Defining expected behavior and outputs.

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI that requires a "training set" of data in the conventional sense. The software validation refers to qualification, not machine learning model training.

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

• Not applicable. As there is no machine learning "training set," there is no "ground truth" established for it.

Ask a specific question about this device

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.

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 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).

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

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.

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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