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The Angiography Injector is intended to aspirate and inject contrast media in the interventional procedure. It can also be used to inject fluids into, or withdraw fluids from the body.

The Angiography Injector is intended to provide the function of aspirating and injecting contrast media in the interventional procedure. It can also be used to inject fluids into, or withdraw fluids from the body. The proposed device is intended for single use and is provided sterile using EO sterilization.

The Angiography Injector consists of six components: 1) Piston, 2) Plunger cap, 3) Push-button 4) Barrel, 5) Plunger and 6) Adapter (rotating or fixed). The proposed device is available in volume of 6mL, 8mL, 10mL and 12mL.

The primary package is blister package and plastic paper package. The blister package and plastic paper package all consist of PE film and Tyvek®2FS paper.

The provided text is a 510(k) summary for a medical device called "Angiography Injector." This document describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed to demonstrate substantial equivalence.

However, the 510(k) summary does not contain information related to a study proving the device meets specific acceptance criteria in the context of AI/ML performance, human reader studies (MRMC), or a detailed setup for establishing ground truth as typically observed in AI/ML medical device submissions.

The document discusses "acceptance criteria" only in the general sense of meeting design specifications and regulatory standards for a conventional angiography injector (e.g., biocompatibility testing results showing acceptance criteria met, performance tests meeting ISO 7886 requirements). It specifically states: "No clinical study is included in this submission."

Therefore, based on the provided text, I cannot answer the questions about:

• A table of acceptance criteria and reported device performance related to AI/ML or human reader studies.
• Sample sizes for test sets (for AI/ML).
• Data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for test sets.
• MRMC comparative effectiveness study or human reader improvement with AI.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI/ML.
• Sample size for the training set (for AI/ML).
• How ground truth for the training set was established.

This is because the device described is a physical medical instrument (an angiography injector and syringe), not an AI/ML-driven diagnostic or assistive software. The "performance testing" mentioned refers to engineering and safety bench tests (e.g., force to operate piston, freedom from air/liquid leakage, sterility, biocompatibility etc.), not diagnostic performance on medical images.

In summary, the provided document does not support a response to the specific questions regarding AI/ML device performance or clinical study methodologies.

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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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100 mL/200 mL Syringe: The Disposable Syringe (Kit) (100 mL or 200 mL Syringe for the injection of contrast media orsaline for CT and MR imaging, for use on Nemoto injectors. 150 mL Syringe: The Disposable Syringe (Kit) (150 mL Syringe for the injection of contrast media or saline forangiography. for use on Nemoto injectors. J-Tube: J-Tube is to aid in transferring a media from its container (typically a vial or bottle) into the barrel of the Disposable Syringe (Kit). Extension Tubes: The Extension Tube is to provide a connection between the syringe barrel and the needle or catheter into the patient.

The "Disposable Syringe (Kit)" (Subject Device) is specifically designed for use with the Nemoto power injection systems marketed and sold in the USA using 510(k) references K133189, K071691, K173450, K092896, K091734. The Subject Device is a package provided to the end user that contains one or two plastic syringes, plastic tubing used for connecting syringe to needle or catheter (Extension Tubing) and a plastic J-shaped tube for transferring contrast media or physiological saline into the plastic syringe (J-Tube). The Subject Device, in accordance with the Indications for Use, may be used in conjunction with CT or MRI applications or in conjunction with angiographic applications. The key difference in the application as it relates to the Subject Device is the pressure required and the flow rates required for the Subject Device. The Subject Device when used for the CT and MRI applications must support a maximum pressure of 300PSI and a maximum flow rate of 10mL/second. The Subject Device when used for the angiographic applications must support a maximum pressure of 1200PSI and a maximum flow rate of 30ml/second. The maximum values related to the application are controlled by the Nemoto power injection system which are fully described in the aforementioned 510(k)s.

The provided text is a 510(k) summary for a medical device (Disposable Syringe (Kit)) and does not contain information about an AI/ML device. Therefore, the questions related to AI/ML device acceptance criteria and study details cannot be answered based on the provided input.

However, I can provide a summary of the non-clinical performance data presented for the Disposable Syringe (Kit), which demonstrates it meets its acceptance criteria based on established standards.

Non-Clinical Performance Data for Nemoto Disposable Syringe (Kit)

The Nemoto Disposable Syringe (Kit) underwent extensive non-clinical testing to demonstrate substantial equivalence to its predicate devices. The device passed numerous tests in accordance with internal requirements, national standards, and international standards.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:
The document does not specify the sample sizes used for each non-clinical test. The tests are general performance and materials tests, not based on patient data.

3. Number of Experts and Qualifications for Ground Truth:
Not applicable. These are non-clinical engineering and laboratory tests, not clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method:
Not applicable. This is not a clinical study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI-assisted diagnostic device.

6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is a physical medical device.

7. Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is defined by the specific parameters and thresholds set by the relevant ISO standards (e.g., ISO 10993, ISO 7886-1, ISO 8536-9, ISO 80369-7) and internal requirements. These standards specify acceptable limits for various properties like cytotoxicity, leakage, tensile strength, and dimensions.

8. Sample Size for Training Set:
Not applicable. This is a physical medical device, not an AI/ML system requiring a training set.

9. How Ground Truth for Training Set Was Established:
Not applicable.

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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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Single-use Sterile High-pressure Angiographic Syringe and Accessories are intended for the injection of contrast media or saline, they shall be used with U.S. legally marketed angiographic injectors.

The proposed device is intended for the injection of contrast media or saline. It includes disposable syringes, connection tube, J shape tube, and spike.

Syringe: The syringes are intended to be used with an U.S. legally marketed angiographic injector.

Compatibility is shown in the Table 1 Compatibility between Syringe and Injectors. (Note: the newly added and the difference between K211564 and the proposed device is highlighted in Red.)

Connection tube: it is used to connect the syringe and the catheter. The tubes (extension tube) are also available in various configurations, which are Type B (used with single shot syringe, highlighted in Red mark), renamed "Straight tube" to "Type B" and added a new model (400204) connecting tube in the Table. The product structure, manufacturing process, product materials have not changed. Type Y and type T tube are used with dual shots syringe. The pressure specification for connection tube is provided in Table 2 Pressure Specifications for Connection Tube. (Note: the newly added and the difference between K211564 and proposed device is highlighted in Red)

J shape tube: it is used to draw contrast media/saline into the syringe barrel before installation.

Spike: it is used to draw contrast media/saline into the syringe barrel before the syringe installation. The pressure specification for the spike is provided in the following table as Table 3 Pressure Specifications for Spike (Note: this model is only used to distinguish whether it is made with or without DEHP). The product materials, manufacturing process and product structure have not changed. Spikes not made with DEHP are marked with Red. The new additions of spike models are: 700204- 1, 700204-2,700205-1, 700205-2, 700206, 700207-1, 700207-2)

This document is an FDA 510(k) summary for a medical device, specifically Single-use Sterile High-pressure Angiographic Syringes and Accessories. It outlines the comparison between the proposed device and a legally marketed predicate device to establish substantial equivalence.

Important Note: This document describes a medical device clearance process for physical hardware (syringes and accessories), not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested categories related to AI/MRMC studies, expert consensus on images, ground truth for training/test sets, etc., are not applicable to this type of submission. The 'acceptance criteria' here refer to meeting engineering and biocompatibility standards, and 'proving the device meets the acceptance criteria' is done through non-clinical laboratory testing.

Here's an attempt to answer your questions based on the provided text, while acknowledging that many are not relevant for this device type:

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

The acceptance criteria are primarily defined by adherence to recognized international and ASTM/USP standards for medical devices and the ability to withstand specified pressures. The reported performance confirms compliance with these standards and pressure specifications.

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 states "Nonclinical tests were conducted to verify that the proposed device met all design specifications." and refers to compliance with ISO, ASTM, and USP standards. However, specific sample sizes for each non-clinical test are not disclosed in this summary. The data provenance is internal testing conducted by Shenzhen Boon Medical Supply Co., Ltd. (China). This would be prospective, laboratory-based testing of manufactured units, not retrospective analysis of patient 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)

Not Applicable. This is a hardware medical device; no "ground truth" based on expert medical opinion (like for imaging diagnosis) is established for the purpose of these non-clinical tests. The "truth" is whether the device meets engineering specifications and safety standards as measured by laboratory equipment.

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

Not Applicable. As this is a hardware device undergoing non-clinical engineering and biological safety tests, there is no adjudication process involving multiple human reviewers for a "test set" in the context of diagnostic accuracy. Test results are objective measurements against defined 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

Not Applicable. This device is a physical syringe and accessories, not an AI software or system that assists human readers in diagnosis. No MRMC study was performed.

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

Not Applicable. This is not an algorithm or software device.

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

The "ground truth" in this context is defined by international, national, and industry-recognized standards and specifications (e.g., ISO, ASTM, USP) for medical device performance, safety, and biocompatibility. Compliance is determined by objective laboratory measurements and tests against these established benchmarks.

8. The sample size for the training set

Not Applicable. As this is a hardware device, there is no "training set" in the context of machine learning or AI.

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

Not Applicable. There is no training set.

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The Disposable High-pressure Extension Lines is indicated for use as a connecting line for injection of contrast media or saline during coronary angiographic procedures.

Not Found

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for "Disposable High-pressure Extension Lines," which is a medical device. This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the text does not include:

• Details about acceptance criteria for device performance.
• Results of a study proving the device meets acceptance criteria.
• Information on sample sizes for test sets (or training sets, for that matter).
• Any mention of data provenance (country of origin, retrospective/prospective).
• Details about experts used for ground truth establishment or their qualifications.
• Adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect sizes related to human reader improvement with AI assistance.
• Whether a standalone algorithm performance study was done.
• The type of ground truth used (expert consensus, pathology, etc.).
• How ground truth for a training set was established.

This document specifically concerns a physical medical device (extension lines for angiographic injectors), not an AI/Software as a Medical Device (SaMD) that would typically involve the types of studies and criteria you've asked about (e.g., performance metrics, ground truth, expert readers, training sets).

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.

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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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High Pressure Tubing is indicated for use in PTCA surgery to connect the angiographic catheter and the angiographic syringe to deliver contrast media.

High Pressure Tubing is designed as a connecting line for injection of contrast media during coronary angiographic procedures. The device has a pressure resistance of 1200psi (8.3MPa); It is divided into two series according to the luer connector combination. ETM series consists of tubing and rotating male luer connecters, and the ETF series consists of tubing and rotating male luer connecter; The rotating male luer connector and female luer connector are made of polycarbonate and silica gel; The tubing is made of polyurethane, and the middle of the tube wall also contains nylon braided wire, which does not contact with outside. The High is for single use only, non-pyrogenic, sterilized by EO gas and the sterilization process is validated.

The question asks to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. However, the provided text is a 510(k) Pre-market Notification for a "High Pressure Tubing" device, which describes its comparison to a predicate device and includes information about performance testing, but it does not contain information typically found in a study proving an AI/ML device meets acceptance criteria.

Specifically, the document discusses a medical device that is a physical product (High Pressure Tubing) used in PTCA surgery. It does not mention any AI or machine learning components. Therefore, information regarding "sample sizes used for the test set," "data provenance," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," or "how ground truth for training set was established" is completely absent and not applicable to this document.

The document primarily focuses on establishing substantial equivalence to a predicate device by comparing technological characteristics and presenting results of biocompatibility and bench testing.

Based on the provided text, the following information can be extracted regarding the physical device's performance testing, which is analogous to "acceptance criteria" and "device performance" for a non-AI medical device:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the bench testing section):

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

• Not Applicable. The document describes performance and bench testing of a physical medical device, not a software or AI/ML device. Specific sample sizes for each test are not provided, nor is data provenance in the context of clinical studies (e.g., country of origin, retrospective/prospective). The tests were conducted to assure reliable design and performance.

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. This information is relevant for AI/ML device validation where human experts establish ground truth. For this physical device, the "ground truth" is established by adherence to recognized international standards (e.g., ISO 10993, ISO 8536-4, ISO 80369-7, ISO 80369-20).

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

• Not Applicable. Adjudication methods are used in clinical studies or expert reviews for AI/ML devices to resolve discrepancies in ground truth establishment. This document pertains to physical device testing.

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. MRMC studies are specific to AI/ML devices involving human readers. This document is about a physical high-pressure tubing.

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

• Not Applicable. This concept is only relevant for AI/ML algorithms.

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

• Not Applicable. For this physical device, "ground truth" is adherence to established engineering specifications and international standards for medical device safety and performance.

8. The sample size for the training set:

• Not Applicable. This device is a physical product and does not involve AI/ML models that require training data.

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

• Not Applicable. This device is a physical product and does not involve AI/ML models that require training data.

In summary, the provided document is a 510(k) Pre-market Notification for a conventional (non-AI/ML) medical device. Therefore, most of the questions related to AI/ML device validation are not applicable. The "acceptance criteria" and "device performance" for this specific device are demonstrated through adherence to relevant international standards and successful completion of biocompatibility and bench testing as listed above.

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The Everest 20cc Inflation Device/Survival Kit is to be used to facilitate the use of catheters and guide wires during interventional procedures. The Everest 20cc Inflation Device is designed to inflate/deflate balloon catheters as well as to monitor pressure within the balloon. The Y/Tri-Adapter with Hemostasis Valve is designed to be used on a guiding catheter or dilatation catheter to control backbleeding and to provide a port for introduction of fluids into the interventional system. The Guide Wire Insertion Tool is designed to facilitate placement of a guide wire tip through the Y/ Tri-Adanter and into the wire lumen of an interventional catheter. The Guide Wire Steering Handle is designed to hold a small diameter guide wire and provide a handle for manipulating the wire.

Medtronic's Everest™ Disposable Inflation Device is a sterile 20cc inflation device with a locking mechanism that is operated via a trigger. Normally, the locking mechanism is engaged. Once the trigger is pulled back, the locking mechanism is released and the piston can be manually manipulated. The Everest™ 20 Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20 bars in 0.5bar increments. The Everest™ 30 Device is outfitted with a manometer with measuring pressure reading from vacuum to 30 bars in 1 bar increments. A high pressure connecting tube with a male rotating adapter and a disposable 3-way stopcock are also included to aid in preparation of the device. When purchased as a "Survival Kit", the package includes a Y-/ Tri-Adapter with hemostasis valve, a Guide Wire Insertion Tool and a Steering Handle.

The document describes a 510(k) premarket notification for Medtronic's Everest™ Inflation Device and Survival Kits. This is a medical device, and the submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing related to packaging and shelf-life, rather than clinical efficacy. Therefore, a traditional "study" proving the device meets acceptance criteria in terms of clinical performance or an AI algorithm's performance isn't applicable here.

Instead, the document details the acceptance criteria for packaging performance and shelf-life, and the tests conducted to show the device meets these criteria. The approval is based on the device being "substantially equivalent" to an existing, legally marketed predicate device, not on demonstrating new clinical efficacy.

Here's the information requested, adapted to the context of this device submission:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device relate to its packaging and shelf-life, ensuring it maintains sterility and integrity. The document states that "No new safety or effectiveness issues were raised during the testing. The test data demonstrated that the modified Medtronic's Everest™ Inflation Devices is as safe and effective as the legally marketed predicate device." This implies that all tested criteria were met.

Due to the nature of the document detailing specific tests rather than numerical performance metrics for each acceptance criterion, a direct table of "performance" for each against a criterion is not provided with exact values. However, the document lists the performed tests, which serve as the acceptance criteria. The "Reported Device Performance" is broadly stated as successful.

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

The document does not explicitly state the numerical "sample size" for the non-clinical packaging and shelf-life tests. This type of information is typically found in the full test reports, which are not included in this summary.

The "data provenance" is internal to Medtronic (manufacturer), based on testing performed on the modified Everest™ Inflation Devices. It is retrospective in the sense that the tests are performed on manufactured devices to confirm design and material changes maintain equivalence.

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

This question is not applicable to this type of device submission. The tests are physical and chemical property tests on packaging and product integrity, not diagnostic or clinical assessments requiring expert human interpretation or "ground truth" establishment in the medical sense. The "ground truth" here is the physical measurement or observation of the packaging and device components against engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. Physical performance tests on a device's parts and packaging do not typically involve adjudication methods like those used for interpreting medical images or clinical outcomes. The results are obtained directly from laboratory measurements and observations.

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 (inflation balloon and accessories) is a mechanical tool used in interventional procedures. It is not an AI-powered diagnostic or assistive tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable. This device does not involve an algorithm or AI component.

7. The Type of Ground Truth Used

For the non-clinical tests (packaging and shelf-life), the ground truth is established by engineering specifications, industry standards (e.g., ISO 15223-1 mentioned for symbols), and regulatory requirements for medical device packaging integrity and sterility. The outcome of these tests determines if the device meets these pre-defined physical and performance benchmarks.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable. There is no training set for this device.

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Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline: they shall be used with US legally marketed angiographic injectors.

The subject devices are identical to all models of predicate devices of K192657. It includes disposable syringes, connection tube, J shape tube and spike. Labeling of subject device now includes pediatrics in the patient population.

This document is a 510(k) summary for Sterile High-pressure Angiographic Syringes for Single-use. It primarily focuses on demonstrating substantial equivalence to a predicate device (K192657) and does not contain information about a study proving specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity for AI/ML technologies.

This type of submission typically demonstrates the device meets a set of performance standards or specifications, rather than a "study that proves the device meets the acceptance criteria" in the way a clinical trial or AI performance study would. The acceptance criteria here relate to physical, chemical, and biological properties, as well as compatibility.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance studies, and training set details, are not applicable to this type of device submission.

Here's the available information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various non-clinical tests and standards that the device complies with, along with some performance specifications.

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 does not specify sample sizes for the individual non-clinical tests (e.g., number of syringes tested for pressure, number of samples for biocompatibility).
• Data provenance: Not explicitly stated, but the submission is from Shenzhen Boon Medical Supply Co., Ltd. in China, suggesting the tests were likely conducted in China. The submission itself is dated August 13, 2021, and received August 23, 2021, implying these are retrospective test results for device validation.

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 is not applicable. The "ground truth" for this medical device (angiographic syringes) involves meeting engineering specifications and biological safety standards, not diagnostic interpretations that require expert consensus. The compliance is against defined standards (e.g., ISO, ASTM, USP) and internal specifications.

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

• This is not applicable for this type of device. Adjudication methods are typically used in clinical studies for diagnostic accuracy, where disagreements between readers or algorithms need resolution. Here, the tests yield objective pass/fail results against established 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

• This is not applicable. The device is a physical medical instrument (syringe), not an AI/ML diagnostic or assistive tool.

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 instrument (syringe), not an AI/ML algorithm.

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

• The "ground truth" in this context is defined by international and national standards (e.g., ISO 10993, ASTM F88, USP 41) and the device's own engineering specifications (e.g., maximum pressure resistance, volume, material properties). Compliance is measured against these objective criteria.

8. The sample size for the training set

• This is not applicable. There is no AI/ML component, therefore no "training set."

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

• This is not applicable. There is no AI/ML component, therefore no "training set" ground truth.

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