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MEDRAD® Centargo CT Injection System is an automated contrast injection system that is indicated for the controlled, automatic administration, on the venous side, of ULTRAVIST® (Iopromide), ISOVUE® (Iopamidol), OPTIRAY® (loversol), or OMNIPAQUE™ (lohexol) contrast media as supplied in an approved Imaging Bulk Package (IBP) presentation and 0.9% Sodium Chloride Injection USP (saline) to human subjects undergoing examinations in computed tomography (CT). The system is to be used 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.

The Day Set is used for a maximum time of twenty-four (24) hours, or for a maximum of 25 bottles of contrast media, whichever comes first. The Patient Line must be discarded after each patient procedure. The Replacement Spike is for single-container use only and must be discarded with the fluid container. Contrast media containers are to be discarded after their respective use times have expired or the Day Set use life has expired, whichever occurs first.

Saline should only be used to deliver multiple single doses to multiple patients when used with the MEDRAD® Centargo CT Injection System and the provided Saline Tag. Once the port of the saline container is punctured, it should not be removed from the work area during the entire period of use. Saline containers are to be discarded with the Day Set.

The ISI2 Module is indicated for the specific purpose of allowing an injector to interface with an imaging scanner.

The MEDRAD® Centargo CT Injection System (Centargo) is an automated contrast injection system intended to be used to inject intravenous contrast media and saline into humans for diagnostic studies in CT applications. Centargo is intended for use with the following approved contrast media in an Imaging Bulk Package (IBP):

• . ULTRAVIST® (Iopromide) NDA 021425/S-034
• . ISOVUE® (Iopamidol) NDA 020327/S-023
• . OPTIRAY® (loversol) IBP NDA 020923/S-026
• . OMNIPAQUE™ (lohexol) NDA 020608/S-045

Centargo is based on well-established technologies for injection, using a piston-based electromechanical device. The system is designed to protect the patient against air injection by incorporating multiple sensors to detect air within the fluid pathway. The system is comprised of two main modules:

• Scan Room Unit – responsible for handling the contrast/saline and delivering injections
• . Control Room Unit - controls, monitors, and communicates with the Scan Room Unit through wired or wireless connection

The Scan Room Unit is located within the scan room whereas the Control Room Unit is not. When communicating via wired or wireless connection, the Control Room Unit can remotely control the Scan Room Unit and initiate and execute injections. However, the Scan Room Unit can operate independently without the use of the Control Room Unit via the Scan Room Unit's graphical user interface (GUI).

The Scan Room Unit is available in two different configurations:

• . Pedestal with battery and AC power
• Overhead mount with AC power only ●
  The fluids are delivered from a multi-patient disposable set (Day Set) through a single use patient line (Patient Line). The Day Set is labeled for 24 hours or for a maximum of 25 bottles of contrast media, whichever comes first. Fluid source spikes (Replacement Spike) are for single container use.

The system is intended to be used in a CT suite. It is intended to be operated by personnel with training and experience in CT procedures and use of CT injection systems. Operators will consist of radiological technologists trained in the use of the equipment. This system is intended for use on the general patient population, including adults and pediatrics.

The provided text describes a 510(k) premarket notification for the MEDRAD® Centargo CT Injection System. This submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific clinical acceptance criteria for an AI/ML model for diagnostic purposes.

Therefore, the information required to populate a table of acceptance criteria for an AI model (like sensitivity, specificity, AUC) and details about study design for AI model performance (expert ground truth, MRMC studies, training set details) are not present in the provided document. The document describes a medical device, an angiographic injector, and the testing outlined is typical for hardware and software validation of such a device, including:

• Performance testing: Verification of injection volume, flow rate accuracy, pressure accuracy, air detection, heat maintenance, battery performance, occlusion detection, and protocol management.
• Software Verification and Validation Testing: Adherence to IEC 62304 and FDA guidance for device software.
• Biocompatibility Testing: According to ISO 10993-1.
• Chemical Compatibility Testing: With various contrast media.
• Cleaning and Disinfection Validation Testing:
• Sterility, Packaging, and Shelf-Life Testing: Adherence to ISO standards.
• Contamination Control Testing: Microbial ingress and cross-contamination studies.
• Human Factors/Usability Testing: According to IEC 62366-1 and FDA guidance.
• Reliability Testing:
• Electromagnetic Compatibility (EMC) and Electrical Safety Testing: Adherence to ANSI/AAMI IEC standards.

The document explicitly states "Animal Studies: Not Applicable" and "Clinical Testing: Not Applicable." This reinforces that the submission is about a device (injector) and its accessory components, not a diagnostic AI/ML algorithm that would undergo the rigorous clinical validation described in your prompt.

Based on the information available in the provided text, it is not possible to complete the requested table and answer the specific questions about AI/ML model acceptance criteria and study details. The document provides information relevant to the safety and effectiveness of an injection system, not an AI diagnostic tool.

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ulricheasyINJECT Max 2M (XD 10140) / 3 (XD 10150) 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 magnetic resonance (MR) applications.

ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is specifically indicated for use in MRI procedures for the delivery of Clariscan (Gadoterate Meglumine) Injection - GE Healthcare Inc., Gadavist (gadobutrol) Injection - Bayer HealthCare Pharmaceuticals Inc., VUEWAY™ (gadopiclenol) – Bracco Diagnostics, Inc., MultiHance (gadobenate dimeglumine) - Bracco Diagnostics, Inc., and Gadobutrol Injection - Fresenius Kabi AG, contrast media as supplied in approved single dose bottles and Gadavist (gadobutrol) Injection - Bayer HealthCare Pharmaceuticals Inc. and Gadobutrol Injection - Fresenius Kabi AG, contrast media as supplied in approved Imaging Bulk Packages (IBPs).

ulricheasyINJECT Max 3 (XD 10180) 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 magnetic resonance (MR) applications.

ulricheasyINJECT Max 3 (XD 10180) is specifically indicated for use in MRI procedures for the delivery of VUEWAY™ (gadopiclenol) Injection - Bracco Diagnostics, Inc., MultiHance (gadobenate dimeglumine) - Bracco Diagnostics, Inc., Clariscan™ (Gadoterate Meglumine) Injection - GE Healthcare Inc., Dotarem® (gadoterate meglumine) Injection -Guerbet, LLC, Gadavist™ (gadobutrol) Injection - Bayer HealthCare Pharmaceuticals Inc., and Gadobutrol Injection -Fresenius Kabi AG, contrast media as supplied in approved single dose vials and Gadavist™ (gadobutrol) Injection -Bayer HealthCare Pharmaceuticals Inc. and Gadobutrol Iniection - Fresenius Kabi AG. contrast media as supplied in approved Imaging Bulk Packages (IBPs).

ulricheasyINJECT Max is a syringeless contrast media management system that is designed for the controlled, automatic venous administration of contrast media in conjunction with physiological saline solution to human subjects undergoing diagnostic examinations in Magnetic Resonance Imaging (MRI or PET MRI).

The ulricheasyINJECT Max device consists of a terminal, injector, and tubing system. The injector is a mobile pedestal device that consists of an injector base with rechargeable battery. The 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 tubing system consists of the following three components:

• Spikes,
• Easy-Click-Cassette flex
• Patient Tubing

The ulricheasyINJECT Max uses a peristaltic pump as part of the injector which is designed to transport the media fluid through the tubing system (spikes, cassette, and patient tubing). ulricheasyINJECT Max is intended to be used with the following components that are not supplied with the system:

• Saline containers.
• Single-dose contrast media bottles,
• IBP contrast media containers, and
• Cannula.

ulricheasyINJECT Max is equipped with multiple hardware and software controls that work together for the safe operation of the intended use of the system. Controls include air detectors to detect the presence of air in the tubing system 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 ulricheasyINJECT Max is provided in three models:

• ulricheasyINJECT Max 2M (XD 10140),
• ulricheasylNJECT Max 3 (XD 10150), and
• ulricheasylNJECT Max 3 (XD 10180).

The Max 3 models have 3 media connection points: 1 NaCl and 2 Contrast Media connections. The Max 2M has 2 media connection points: 1 NaCl and 1 Contrast Media connections. Max 2M and Max 3 are technically identical except the different available media connection points.

The provided text describes a 510(k) premarket notification for the ulricheasyINJECT Max contrast media management system, which primarily references a previously cleared predicate device (K233737) for most of its acceptance criteria and supporting studies. The information available focuses on the differences between the current device and its predicate.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets alongside "reported device performance" in a separate column. Instead, it describes various non-clinical tests conducted for the predicate device (K233737) and states that the subject device (ulricheasyINJECT Max) supports a broader range of contrast media, with additional testing performed to address this difference.

The following table summarizes the performance characteristics and states of verification for the device and its predicate:

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

• Sample Size: The document does not specify exact sample sizes for each test set. It mentions "studies" and "testing" without providing numerical details for the number of units or data points tested in non-clinical assessments.
• Data Provenance: All non-clinical testing (Software, EMC/Electrical Safety, Sterilization Validation, Shelf Life and Transport Validation, Contamination Control and Rinsing, Biocompatibility, Performance – Bench, Extractables and Simulation, Human Factors / Usability) was performed as part of K233737, indicating it was conducted for the predicate device. Additional chemical compatibility testing was conducted for the current submission (K241850) to support new contrast media. The origin of the data (e.g., country) is not specified beyond being part of ulrich GmbH & Co. KG's submission, implying internal company testing. Studies are described as "non-clinical" and "bench," which means they are not human clinical trials.

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

Not applicable. The document discusses non-clinical bench testing, not image-based diagnostic performance involving expert readers establishing ground truth. The "Human Factors / Usability" study confirms the device's safety and effectiveness for its intended users (trained healthcare professionals), but it's not about expert clinical interpretation for a diagnostic algorithm.

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

Not applicable. This type of adjudication method is used for establishing ground truth in diagnostic studies involving multiple human readers, which is not described in this document.

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

Not applicable. This device is a contrast media management system, not an AI-powered diagnostic imaging tool. Therefore, MRMC studies are not relevant.

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

Not applicable. This device is a physical medical device (an injector) with software controls, not an algorithm meant for standalone diagnostic performance.

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

For non-clinical testing, "ground truth" generally refers to established scientific principles, engineering specifications, recognized industry standards (e.g., ISO, IEC), and predetermined specifications for the device's performance. For biocompatibility, it's compliance with ISO 10993-1. For sterilization, it's achieving a specified Sterility Assurance Level. For performance metrics like flow rate and volume accuracy, it's meeting the ±5% specification.

8. The sample size for the training set

Not applicable. The document refers to a physical medical device and its controls, not a machine learning model that requires a training set.

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

Not applicable, as no training set for a machine learning model is mentioned.

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ulricheasyINJECT Max System Max 2M (XD 10140) and Max 3 (XD 10150) 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 magnetic resonance (MR) applications.

ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is specifically indicated for use in MRI procedures for the delivery of Clariscan (Gadoterate Meglumine) Injection, - GE Healthcare Inc. contrast media as supplied in approved single dose bottles.

Easy-Click-Cassette – flex Max 2M and Easy-Click-Cassette – flex Max 3 are used for a maximum time of twenty four (24) hours or a maximum of 96 bottles of contrast media, or whichever comes first. Use time expiration per single dose contrast media container is a maximum of four (4) hours per contrast media container, unless otherwise stated by the contrast media labeling.

Spike for MRI 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.

ulricheasyINJECT Max 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.

The ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is not intended for injection of contrast media (CM) for high-pressure angiography.

ulricheasyINJECT Max 3 (XD 10180) 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 magnetic resonance (MR) applications.

ulricheasyINJECT Max 3 (XD 10180) is specifically indicated for use in MRI procedures for the delivery of VUEWAY™ (gadopiclenol), - Bracco Diagnostics Inc, MultiHance (gadobenate dimeglumine) – Bracco Diagnostics, Inc, Clariscan™ (Gadoterate Meglumine) Injection, - GE Healthcare Inc., Dotarem® (gadoterate meglumine) Injection - Guerbet, LLC, and Gadavist™ (gadobutrol) Injection, - Bayer HealthCare Pharmaceuticals Inc., contrast media as supplied in approved single dose vials.

Easy-Click-Cassette - flex Max 3 is used for a maximum time of twenty four (24) hours or a maximum of 96 bottles of contrast media, or whichever comes first. Use time expiration per single dose contrast is a maximum of four (4) hours per contrast media container, unless otherwise stated by the contrast media labeling.

Spike for MRI 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.

ulricheasyINJECT Max 3 (XD 10180) 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.

The ulricheasyINJECT Max 3 (XD 10180) is not intended for injection of contrast media (CM) for high-pressure angiography.

ulricheasyINJECT Max is a syringeless contrast media management system that is designed for the controlled, automatic venous administration of contrast media in conjunction with physiological saline solution to human subjects underqoing diagnostic examinations in Magnetic Resonance Imaging (MRI or PET MRI).

The ulricheasyINJECT Max device consists of a terminal, injector, and tubing system. The injector is a mobile pedestal device that consists of an injector base with rechargeable battery. The 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 tubing system consists of the following three components:

• . Spikes,
• . Easy-Click-Cassette - flex
• . Patient Tubing

The ulricheasyINJECT Max uses a peristaltic pump as part of the injector which is designed to transport the media fluid through the tubing system (spikes, cassette, and patient tubing), ulricheasylNJECT Max is intended to be used with the following components that are not supplied with the system:

• Saline containers,
• Single-dose contrast media bottles, and .
• . Cannula.

ulricheasylNJECT Max is equipped with multiple hardware and software controls that work together for the safe operation of the intended use of the system. Controls include air detect the presence of air in the tubing system 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 ulricheasyINJECT Max is provided in three models:

• . ulricheasyINJECT Max 2M (XD 10140),
• . ulricheasyINJECT Max 3 (XD 10150), and
• . ulricheasyINJECT Max 3 (XD 10180).

The Max 3 models have 3 media connection points: 1 NaCl and 2 Contrast Media connections. The Max 2M has 2 media connection points: 1 NaCl and 1 Contrast Media connections. Max 2M and Max 3 are technically identical except the different available media connection points.

The ulricheasyINJECT Max system, a contrast media management system, underwent a comprehensive study to demonstrate its substantial equivalence to a predicate device, ulrichINJECT CT motion (K192872). The study focused on non-clinical testing to ensure its safety and effectiveness for its intended use in magnetic resonance (MR) applications.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" for each test in a numerical or pass/fail format. Instead, it states that "Verification results indicate that the ulricheasyINJECT Max tubing system complies with the standard" or "conforms to its predetermined specifications." The "Comparison" column in the Comparative Analysis table acts as a high-level summary of performance against the predicate.

Below is a table summarizing the areas tested and the reported performance based on the provided text:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the numerical sample sizes for the test sets used in the non-clinical studies (e.g., number of units tested for EMC, number of samples for chemical compatibility). It refers to the tests performed and their general outcomes.

The data provenance is from non-clinical testing performed by ulrich GmbH & Co. KG, for the purpose of a 510(k) premarket notification. This indicates the data is prospective in the context of device validation. The "country of origin of the data" is not explicitly stated but the submitter is based in Ulm, Germany.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable as the described studies are non-clinical (bench testing, software validation, biocompatibility, etc.) and do not involve human readers or refer to "ground truth" in the context of expert review of clinical cases.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document describes non-clinical testing and comparison to a predicate device, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, the studies described are analogous to standalone performance evaluation for the device's functional and safety aspects. The software and various physical parameters (e.g., flow rate accuracy, air detection) were tested independently of human intervention during the functional tests, demonstrating the device's inherent performance. Human Factors/Usability assessments considered human interaction but focused on the device design's safety and effectiveness, not the clinical performance of an algorithm.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" was established by recognized industry standards and predetermined specifications for device performance, safety, and material properties. Examples include:

• IEC 60601-1 for electrical safety and EMC.
• ISO 11135:2014 for sterilization.
• ISO 10993-1 for biocompatibility.
• ISO 8536-4:2010 (applicable requirements) for infusion equipment performance.
• Internal predetermined specifications for aspects like flow rate accuracy (± 5%), volume accuracy (± 5%), air detection limit (0.05 mL), and alarm limits.

8. The Sample Size for the Training Set:

This information is not applicable. The document describes a contrast media injector system, not an AI/ML algorithm that requires a separate training set. The "software verification and validation" refers to traditional software testing, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no mention of an AI/ML training set.

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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.

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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.

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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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 OptiOne Single-Head Contrast Delivery System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images with computed tomography (i.e. "CT") equipment.

The OptiOne Single-Head Contrast Delivery System (OptiOne) is intended to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used in conjunction with computed tomography equipment. Each injection is accomplished with a motor-driven syringe mechanism with microprocessor control of the flow rate, volume, pressure and timing. The OptiOne consists of the following key components: a Powerhead, a Console, and a Power Supply. The Power Supply delivers power to the Powerhead and Console. The Console provides remote control and programmability of the injection through a touch screen display system. The Powerhead contains the components to perform the actual injection such as motor control circuits, ball screw and syringe push ram.

The provided document is a 510(k) summary for the Liebel-Flarsheim Company LLC's OptiOne Single-Head Contrast Delivery System. It details the device's characteristics and its comparison to a predicate device, focusing on demonstrating substantial equivalence.

However, the document does not contain the specific acceptance criteria, reported device performance data, detailed descriptions of studies (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or information on the ground truth establishment for either test or training sets as requested in your prompt.

The document states: "Extensive verification and validation activities were performed to ensure the OptiOne Single-Head Contrast Delivery System design outputs met all design inputs and the customer requirements were successfully met. The testing confirms the OptiOne Single-Head Contrast Delivery System meets the required specifications." And, "The OptiOne Single-Head Contrast Delivery System was developed under the Liebel-Flarsheim Company LLC Design Control processes. The verification and validation activities ensure the OptiOne meets all customer requirements and product specifications."

This indicates that internal testing was conducted to verify that the device met its specifications, but the specifics of those tests, their results against acceptance criteria, or the methodology of the studies are not included in this publicly available summary.

Therefore, I cannot provide the requested information from the given text.

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The contrast delivery system Sonic Shot GX is an intravascular injection system intended for the administration of MRI contrast media and normal saline solution used in conjunction with magnetic resonance imaging (MRI).

The contrast delivery system Sonic Shot GX is an intravascular injection system intended for the administration of MRI contrast media and saline used in conjunction with MRI.

The main components of the Sonic Shot GX are the Console, Powerhead and Main Control Unit. The Console resides in the control room or the MR suite, while the Main Unit and Powerhead reside in the scanning room alongside the MR scanning device and the patient. The parameters of the injection, such as volume, flow rate and pressure are programmed by the operator via the graphical user interface with touchscreen input. The Console is powered via 24 volts DC which is derived from a remote AC to DC converter (similar to that used with laptop computers) and communicates with Main Control Unit via a fiber-optic interface. The communication link is used to communicate the user set injection parameters to the Main Control and Powerhead located in the MR suite.

After the injection protocol has been set, the Powerhead performs the injection by driving one or two lead screw rams. The rams push the syringe which expels fluid from the barrel of the syringe.

The provided document describes a contrast delivery system (Sonic Shot GX) and primarily focuses on its substantial equivalence to predicate devices, rather than a detailed study report for meeting acceptance criteria of an AI/ML powered medical device. Therefore, much of the requested information (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth for AI models) is not applicable or not present in the provided text, as the device is a hardware injector, not an AI system.

However, I can extract information related to the performance testing done to verify the system meets its specifications.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

The "Summary of Performance Testing" section describes that the device must be capable of achieving "specification parameters for the system as outlined in the substantial equivalence chart." The "Performed Testing" section describes how the device meets those specifications.

Note: The document refers to "allowable specifications" and "allowable ranges," implying specific numerical thresholds, but these thresholds are not explicitly stated in the provided text.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. The document states "During testing" or "Over the range of volumes programmed" but does not provide specific numbers of tests or injections performed.
• Data Provenance: Not specified, but given the manufacturer is Nemoto Kyorindo Co., Ltd. in Japan, it is highly likely the testing was conducted in Japan. The testing described is prospective, as it involves actively performing injections and measuring parameters.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable as the device is a contrast delivery system (hardware), not an AI/ML-driven diagnostic or interpretative device that requires expert-established ground truth for its performance. The "ground truth" here is the physical measurement of fluid dynamics and pressure, compared against engineered specifications.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as above. The performance evaluation relies on objective physical measurements against engineering specifications, not subjective expert judgment requiring adjudication.

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

This information is not applicable. The Sonic Shot GX is a hardware device for injecting contrast media, not a system that assists human readers in interpreting medical images. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

This information is not applicable. The Sonic Shot GX is a mechanical injector. Its performance is measured as a standalone system (it delivers fluid autonomously once programmed), but it does not have an "algorithm-only" performance in the context of AI/ML or image interpretation. Its performance is its standalone mechanical and electronic function.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing of the Sonic Shot GX involves objective physical measurements of:

• Delivered volume
• Measured flow rate
• Actual pressure
• Drip mode increments and intervals
• Manual control speeds

These measurements are compared against the engineering specifications defined for the device.

8. The Sample Size for the Training Set

This information is not applicable. The Sonic Shot GX is not an AI/ML device that requires a training set. Its functionality is based on pre-programmed logic and mechanical engineering, not learned patterns from data.

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

This information is not applicable for the same reason as above.

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The OptiVantage DH Injector System with Enhanced Communication is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.

The OptiVantage DH Injector System with Enhanced Communication delivers radiographic contrast media and/or saline at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The OptiVantage DH Injector System with Enhanced Communication consists of 4 main components, just like the predicate device:

• Power Head- Contains two electromechanical syringe drive systems, the syringe holding mechanisms, the main microprocessor, control electronics, control keypad for programming and initiating injection protocols, a status display, and two purge/retract manual knobs. The OptiVantage uses a drive system that is similar to existing Mallinckrodt injectors in the marketplace. It uses a motor and gearbox coupled to a ball screw. The ball screw drives a ram that attaches to the syringe plunger in order to fill or expel the contents of the syringe.
• Power Supply- The power supply converts the line voltage to the working voltage for the power head and console (approximately 24-vdc).
• Console Communicates with the Power Head to program and initiate injection protocols, displays the injection status, and displays a timer.
• Syringes The OptiVantage DH Injector System with Enhanced Communication accommodates the Syringes - The Oper rainage styles as well as a 200 ml front loading empty syringe. These Minimonrol. I 22 million place on the market and are currently used with the predicate device.

The provided text is a 510(k) summary for the OptiVantage DH Injector System with Enhanced Communication. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for a performance study.

The document is a submission to the FDA for market clearance, focusing on demonstrating that the new device is substantially equivalent to a previously cleared predicate device (K042744). The comparison table highlights features that are identical between the new device and the predicate. The "enhancement" mentioned is an additional layer of enforcement for existing safety features, rather than a new performance characteristic requiring a new clinical performance study with acceptance criteria.

Therefore, many of the requested details about performance studies, data provenance, expert ground truth, etc., are not present in this 510(k) summary document.

Here's a breakdown of what is and is not available in the provided text:

1. Table of acceptance criteria and reported device performance:

• Not available. The document does not specify quantitative acceptance criteria (e.g., specific thresholds for flow rate accuracy or pressure limits) against which a study's results would be measured. It rather lists specifications and features that are identical to the predicate device.

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

• Not available. No performance study or test set is described.

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

• Not available. Not applicable as no performance study with ground truth establishment is described.

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

• Not available. Not applicable.

5. 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:

• Not applicable. This device is a power injector for contrast media, not an AI-assisted diagnostic tool for human readers.

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

• Not available. No standalone performance study is mentioned. The device's performance is implicit in its specifications, which are deemed substantially equivalent to the predicate device.

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

• Not available. Not applicable.

8. The sample size for the training set:

• Not available. Not applicable as no machine learning algorithm development is described.

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

• Not available. Not applicable.

What can be extracted from the document related to "performance" and "criteria":

The document relies on substantial equivalence to a predicate device (OptiVantage DH Power Injection System, K042744). The "acceptance criteria" are implicitly that the new device performs identically or acceptably compared to the predicate for all relevant functions.

Reported Device Performance (based on comparison to predicate):

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