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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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The Artus™ cervical plate system is intended for anterior fixation of the cervical spine (C2 to T1). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

Artus™ is a cervical plate system that provides one- through four-level standard plate designs as well as one- and two-level midline plates. The plates are designed with a blocking mechanism to restrict screw backout. The plating system offers a variety of screw options including self-drilling, self-tapping and self-drilling/self-tapping, all available in either fixed or variable designs and in standard and rescue diameters. The implants are available in a variety of lengths to accommodate the individual anatomic and clinical circumstances of each patient.

The provided document is a 510(k) summary for the Artus™ cervical plate system. This is a medical device for spinal fixation and not an AI/ML powered device. Therefore, the questions related to AI/ML device acceptance criteria, study details, ground truth, expert involvement, and training/test sets are not applicable.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical testing.

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

The document states that mechanical testing of the worst-case Artus™ construct was performed according to ASTM F1717, which includes dynamic compression bending. The acceptance criteria for such tests are generally defined by the FDA and industry standards to ensure the device can withstand physiological loads without failure. While the specific numerical acceptance criteria are not explicitly stated in this summary, the crucial statement is:

"The test results demonstrate that Artus™ device mechanical performance is substantially equivalent to the predicate devices."

This implies that the Artus™ device met or exceeded the performance of the predicate device (uNion™ Cervical Plate System) under the specified ASTM F1717 test, which serves as the de facto acceptance criterion for performance equivalence in this context.

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

This question is not applicable as the device is a physical implant, not an AI/ML software. The "test set" here refers to physical components for mechanical testing, not data.

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 question is not applicable as this is a physical medical device. "Ground truth" in this context would refer to the established engineering standards and performance of the predicate device. Mechanical engineers and quality control experts would be involved in designing and conducting the tests, but not in establishing an "AI ground truth."

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

This question is not applicable for a physical medical device.

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 question is not applicable as the device is a physical implant, not an AI/ML powered device.

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

This question is not applicable as the device is a physical implant, not an AI/ML powered device.

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

For a physical medical device like the Artus™ cervical plate system, the "ground truth" for performance is established through:

• Established engineering standards: Specifically, ASTM F1717 for spinal implant devices. These standards define the methods and expected performance characteristics for simulating physiological loads.
• Performance of the legally marketed predicate device: The Artus™ system's performance is compared to the uNion™ Cervical Plate System (K150666). The predicate's successful history and FDA clearance serve as the benchmark for "ground truth" for substantial equivalence.

8. The sample size for the training set

This question is not applicable as the device is a physical implant and does not involve AI/ML training data.

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

This question is not applicable as the device is a physical implant and does not involve AI/ML training data.

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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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The Small VBR is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The Small VBR is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The Small VBR is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Small VBR is optional.

Small VBR™ is a system of corpectomy devices used to provide mechanical support to the cervical and thoracolumbar spine. Small VBR™ is a cylindrical implant with the capability for device expansion. The ends of the device incorporate a ring of teeth to engage the endplates of adjacent vertebrae. The device is offered non-sterile in various combinations of expansion range, angulation and footprint to accommodate patient anatomy.

The provided text is a 510(k) premarket notification for a medical device called "Small VBR™" (Vertebral Body Replacement). This document describes the device, its intended use, and its equivalence to legally marketed predicate devices, primarily through mechanical testing.

**Crucially, this document does not describe a study involving:

• Acceptance criteria based on AI or diagnostic performance metrics (e.g., sensitivity, specificity, AUC).
• Human readers, radiologists, or expert consensus for ground truth establishment.
• Training or test sets for an algorithm.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.**

Instead, the performance data section states: "Mechanical testing of the worst case Small VBR™ devices included static and dynamic compression and static and dynamic torsion following ASTM F2077. The mechanical test results demonstrate that Small VBR™ device performance is substantially equivalent to itself as a predicate device."

Therefore, based solely on the provided text, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets those criteria in the context of diagnostic performance or AI. The study described is a mechanical testing study for a spinal implant, comparing its physical performance to a predicate device.

Here's what I can extract based on the provided text about the mechanical testing:

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

Note: The specific numerical values for acceptance criteria or device performance are not provided in this document, only that they followed ASTM F2077 and demonstrated substantial equivalence.

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

• Sample Size: Not explicitly stated but implied to be "worst case Small VBR™ devices" for mechanical testing. For mechanical testing, this typically refers to a representative number of devices to ensure statistical validity, but the exact count isn't given.
• Data Provenance: Not applicable in the context of patient data. The "data" refers to mechanical test results from the manufactured devices.

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

• Not applicable. Ground truth for mechanical testing is established by engineering standards (ASTM F2077) and the physical properties of the device, not by expert human interpretation.

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

• Not applicable. This is a mechanical engineering test, not a diagnostic study requiring human adjudication.

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 study was not done. This device is a physical spinal implant, not an AI-powered diagnostic tool.

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

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

7. The type of ground truth used:

• The ground truth is established by the ASTM F2077 standard for mechanical testing of spinal implants.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning study.

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

• Not applicable. This is not an AI/machine learning study.

In summary, the provided document details the regulatory clearance of a physical medical device (spinal implant) based on mechanical testing demonstrating substantial equivalence, not a study evaluating diagnostic performance or AI.

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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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neon3™ is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease. including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. neon3™ is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration of fusion.

neon3™ is a modular, posterior system used for the surgical stabilization and fixation of the occipital, cervical and thoracic regions of the spine. The system components include longitudinal rods, screw and hook anchors, and interconnecting devices such as anchor- to-rod connectors, and rod-to-rod and screw-to-screw crosslinks.

The document describes the neon3™ universal OCT spinal stabilization device, a modular posterior system for spinal stabilization and fixation.

However, the provided text does not contain details about acceptance criteria, device performance metrics, or a study comparing its performance against specific quantitative criteria for diagnostic accuracy or clinical outcomes as would be found in a study proving a device meets acceptance criteria.

Instead, the document details the device's 510(k) premarket notification for FDA clearance, focusing on substantial equivalence to predicate devices based on mechanical testing.

Here's an analysis based on the information available regarding the provided request:

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

The document does not provide a table of acceptance criteria as quantitative metrics (e.g., sensitivity, specificity, accuracy) for device performance in a clinical or diagnostic context.

The performance data section mentions:

• "Mechanical testing of worst case neon3TM craniocervical constructs included static and dynamic compression bending and static torsion according to ASTM F1717 as well as static and dynamic compression bending and static and dynamic torsion per ASTM F2706."
• "The mechanical test results demonstrate that neon3TM performance is substantially equivalent to the predicate devices."

This indicates that the "acceptance criteria" were likely related to meeting the performance specifications outlined in the ASTM standards (F1717 and F2706) for spinal implant mechanical properties, and demonstrating substantial equivalence to predicate devices (Synapse Occipital-Cervical-Thoracic (OCT) System, Halifax Interlaminar Clamp, neon3TM (K150650), and Ascent™ POCT System) in these mechanical properties. The specific numerical values or success/failure thresholds for these mechanical tests are not presented in this document.

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

Not applicable. The "test set" in this context refers to mechanical testing of device constructs, not a clinical data set. The sample size for the mechanical testing is not specified beyond "worst case neon3TM craniocervical constructs". Data provenance is the manufacturing process and materials used for the constructs.

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

Not applicable. This is a mechanical testing study, not a study requiring expert clinical assessment for ground truth.

4. Adjudication method for the test set

Not applicable. This is a mechanical testing study, not a study involving human reader adjudication.

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 is a mechanical testing study for a spinal stabilization device, not an AI-assisted diagnostic or imaging device for which an MRMC study would be relevant.

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

Not applicable. This is a mechanical testing study for a spinal stabilization device.

7. The type of ground truth used

For the mechanical testing, the "ground truth" would be established by the physical and mechanical properties of the materials and constructs themselves, as measured by standardized testing procedures (ASTM F1717 and F2706). The comparison point is the performance of predicate devices, implying that their mechanical properties served as a benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI or machine learning study.

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

Not applicable. There is no training set mentioned.

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The ulrich Transfer Set is indicated for the transfer of OmnipaqueTM (Iohexol) contrast media as supplied in an Imaging Bulk Package to non pre-filled single-use only sterile syringes on syringe-based contrast injection systems indicated for the controlled, automatic administration on the venous side of contrast media for CT procedures. The Transfer Set is to be discarded after the contrast media container has been depleted or 8 hours have elapsed since the container was penetrated. whichever occurs first.

The ulrich Transfer Set (Transfer Set) is a sterile tubing set connection between an imaging bulk package and empty sterile syringes on single-use-only, syringe based contrast injection systems. The Transfer Set consists of a spike with protective cap and integrated air filter on one side, 20" (50.8 cm) tubing segment and one female swabable (also referenced as swabbable) valve (Swabsite Swabbable Valve - K002689) with a protective cap on the other side. The Transfer Set is to be discarded after the contrast media container has been depleted or 8 hours have elapsed since the container was penetrated, whichever occurs first.

The provided text describes the ulrich Transfer Set and its successful 510(k) submission for substantial equivalence to a predicate device. This is a medical device, and the acceptance criteria and supporting studies are focused on its safety and performance standards rather than AI/algorithm performance.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test mentioned (e.g., number of transfer sets tested for sterility, biocompatibility, or performance). The studies are "verification results" indicating compliance with standards, implying a sufficient sample size was used as per the standard's requirements.

• Data Provenance: The studies are laboratory-based bench tests and materials testing, conducted by ulrich GmbH & Co. KG or their contracted testing facilities. The country of origin of the data would likely be Germany (where ulrich GmbH & Co. KG is located) or the location of the testing laboratories. The studies are prospective in the sense that they were conducted specifically for this 510(k) submission to demonstrate compliance.

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

This section is not applicable to this device submission. The ulrich Transfer Set is a physical medical device (an intravascular administration set), not an AI/software device that requires expert-established ground truth for diagnostic or interpretative tasks. The "ground truth" here is defined by meeting established engineering, chemical, and biological standards (e.g., a device is sterile if it meets SAL 10⁻⁶; materials are biocompatible if they pass ISO 10993 tests).

4. Adjudication method for the test set

This is not applicable as it pertains to expert consensus on diagnostic or interpretative AI performance. The tests described are objective, quantitative measurements against predefined standards.

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 is not applicable. The device is an intravascular administration set, not an AI or imaging diagnostic tool. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

This is not applicable. The device is a physical medical device, not an algorithm or AI.

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

As explained in point 3, the concept of "ground truth" in the AI/diagnostic sense is not directly applicable. The "ground truth" for the ulrich Transfer Set's performance is established by:

• International Standards: Compliance with ISO 11135-1, ISO 11607-1/2, ISO 10993 series, ISO 8536-4, ISO 22413, ISO 594-2.
• National Standards: Compliance with ASTM F756-13, ASTM F619-14, USP 38.
• Predetermined Specifications: The device's own internal design and performance specifications confirmed by testing.

8. The sample size for the training set

This is not applicable. The device is a physical medical device, not an AI model that requires a training set.

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

This is not applicable. See point 8.

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neon3™ is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

neon?™ is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

neon 3™ is a modular, posterior system used for the surgical stabilization and fixation of the cervical and thoracic regions of the spine. The system components include longitudinal members, anchors and interconnection devices.

The acceptance criteria and study proving the device meets the criteria are described below:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not applicable. This study primarily involved mechanical testing of the device components, not human subject data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for mechanical testing is established by industry standards (ASTM F1717) and engineering principles rather than expert consensus.

3. Adjudication method for the test set: Not applicable. This was a mechanical testing study, not a clinical study requiring adjudication of expert opinions.

4. 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 spinal fixation system, not an AI software or imaging device that would involve human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a hardware medical device, not an algorithm.

6. The type of ground truth used:

   • Mechanical performance: Established by adherence to ASTM F1717 (standard specification for spinal implant constructs) and engineering design principles.
   • Substantial Equivalence: Demonstrated by comparing the mechanical test results of neon3™ to those of the predicate devices.

7. The sample size for the training set: Not applicable. This refers to a medical device's mechanical performance evaluation, not a machine learning model.

8. How the ground truth for the training set was established: Not applicable.

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