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The Iradimed Corporation's MRidium 3860+ MRI Infusion Pump/Monitoring System is intended for:

• General hospital or clinical use by medical professionals whenever it is required to infuse patients with subcutaneous, intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans, functioning while either in a stationary or mobile position.

• The system is useful in the administration of fluids requiring precisely controlled infusion rates. The system can operate in either continuous, intermittent, or bolus delivery mode.

• The Infusion Pump can be used inside the MRI room mounted outside the 10,000 Gauss line (1 Tesla line), and with shielded magnets of field strength of 3.0 Tesla or less.

• This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.

• The Pulse Oximeter is used to measure, display, and record functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. Testing of the Oximeter was performed in MR conditional environments at 1.5T and 3T. It is indicated for spot checking and/or continuous monitoring of patients who are well or poorly perfused in the MRI.

The infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -100 mmHg as the high negative pressures can result in uncontrolled fluid flow.

The MRidium 3860+ MRI Infusion Pump/Monitoring System with software version 3.5.3 is an MRI compatible IV pump intended for use within the MR Scan room. The device operates to full specification in magnetic fields of up to 10,000 Gauss and has RF emissions at Larmor frequencies up to and including 3.0 Tesla MR scanners (132 MHz) such that image signal to noise is not visibly affected with the pump within 1 foot from the MRI bore opening. The magnetic content of the device is such that there is no hazard of magnetic attraction.

The pump unit is designed with an integral single peristaltic pump channel utilizing an ultrasonic (nonmagnetic) motor. This integral channel is vertically oriented to the right side of the main assembly of the pump unit shall contain the controls, display, power supply, battery, processor/memory functions suitable to meet the complete and expanded system requirements.

The left side of the unit is designed to accommodate attachment of an optional second peristaltic pump channel (Model 3861) which is controlled through the main pump assembly's display and controls. A remote display (Model 3865) is also available for independent viewing and control from the adjacent MRI Control areas.

The Dose Rate Calculator feature, allows the user to set up a patient's infusion rate based upon user selected parameters, including volume to be infused, dose, concentration, weight, and/or time.

The Dose Rate Calculator feature also provides a Drug Library, allowing the user to program a patient's infusion protocol from selected parameters, including volume to be infused, dose, concentration, weight and/or time.

The Drug Library includes a small drug library consisting of 5 drugs (four common medications most frequently infused during MRI procedures, and one customizable drug) and with the DERS library card, can hold up to 50 customizable drugs. The optional DERS library card also includes the ability of setting hard and soft limits for each drug. This Drug Library feature can only be activated/de-activated with a service-related, limited user access menu.

The Dose Error Reduction System (DERS) option (P/N 1145) to the Dose Rate Calculator feature allowing user facilities to program custom drug names, doses, and limits for use in the Dose Rate Calculator. A user programmable drug library memory card stores the specific infusion protocols established by the hospital facility. This library is accessed using the pump's Dose Rate Calculator Menu. The drug library card supports a number of separate user-programmed infusion protocols for either primary and/or primary/bolus infusions, retrievable by drug/protocol name. The library can be programmed with nominal starting values for: Dose, Concentration, and Time. Also, hard limits (maximum and minimum) and soft limits (high and low limits that require a user confirmation to exceed) for: Dose, Concentration, Time and Patient Weight can be programmed. Programming the custom medications and limits is performed with the pump and a dedicated drug library SD Memory Card in the limited access service mode.

The Pulse Oximeter feature of the 3860+ MRI Infusion Pump/Monitoring System is used in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. It is indicated for continuous monitoring of patients in the MRI who are well or poorly perfused. The 3860+ System displays the patient's pulse rate and SpO2 values, as well as applicable alarm limits. The 3860+ System includes adjustable and visual pulse rate and oxygen saturation (SpO2) alarms. It also includes a variety of additional features, including low battery alarms, status indicators and sensor-related alarms. The 3860+ System only uses fiberoptic SpO2 sensors. These fiber optic sensors, cables, and associated finger wrap accessories contain no conductive components; they can be applied safely to the patient while inside an MR (magnetic resonance) environment. The 3860 model number is used for the same infusion device with no SpO2 module.

This document describes the Iradimed Corporation's MRidium 3860+ MRI Infusion Pump/Monitoring System, which is a medical device intended for infusing fluids to patients before, during, or after MRI scans, and for monitoring pulse oximetry. The submission is for a 510(k) premarket notification, claiming substantial equivalence to a predicate device (MRidium 3860 MRI Infusion Pump/Monitoring System, K090087).

Here's the information requested based on the provided text, focusing on the changes from the predicate device (software update and pulse oximeter):

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of an AI/ML device. The testing described is verification and validation (V&V) for the infusion pump and pulse oximeter, and it focuses on the safety and performance of the device's functions, not on a diagnosis or prediction task from a specific dataset. Therefore, information regarding sample size for a test set and data provenance (country of origin, retrospective/prospective) as typically understood for an AI/ML study is not applicable to this submission. The "test set" would typically refer to the data used to evaluate AI model performance, which isn't the primary focus here.

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

As this is not an AI/ML device study involving ground truth establishment by experts on medical imaging or similar data, this information is not applicable. The ground truth for device performance would be established by validated test methods and reference measurements or standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable as there is no mention of a human-adjudicated test set in the context of an AI/ML 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 information is not applicable. The submission is for a medical device (infusion pump/monitoring system) and does not involve AI assistance for human readers in diagnostic tasks.

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

This information is not applicable. This is not an AI algorithm being evaluated for standalone performance. The device itself (infusion pump and pulse oximeter) operates with software, and that software's performance is verified and validated as part of the device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the specific performance testing detailed in this document:

• Software V&V: The ground truth is the design input and safety requirements for the software. This would be established through a rigorous software development lifecycle and adherence to recognized software engineering standards.
• Human Factors: The "ground truth" for human factors is compliance with the usability engineering guidance (FDA guidance). This would involve testing with representative users performing intended tasks.
• Risk Management: The "ground truth" for risk management is adherence to ISO 14971 and the FDA guidance for infusion pumps, ensuring identified risks are mitigated.
• Pulse Oximeter: The "ground truth" for the pulse oximeter's performance (SpO2 and pulse rate measurement accuracy) would be based on established physiological measurement standards and reference devices. The document states that performance specifications are "identical" to the predicate and that the OEM Masimo Set Technology (K053269) for pulse oximetry was previously cleared.

8. The Sample Size for the Training Set

This information is not applicable. The device is an infusion pump and monitoring system, not an AI/ML model that is "trained" on a dataset in the conventional sense. The software development process involves coding and internal testing, not machine learning training.

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

This information is not applicable for the same reasons as point 8.

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The Iradimed Corporation's MRidium 3860 MRI Infusion Pump/Monitoring System is intended for:

• General hospital or clinical use by medical professionals whenever it is required to infuse patients with subcutaneous, intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans, functioning while either in a stationary or mobile position.
• The system is useful in the administration of fluids requiring precisely controlled infusion rates. The system can operate in either continuous, intermittent, or bolus delivery mode.
• The Infusion Pump can be used inside the MRI room mounted outside the 10,000 Gauss line (1 Tesla line), and with shielded magnets of field strength of 3.0 Tesla or less.
• This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.
• The Pulse Oximeter is used to measure, display, and record functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. Testing of the oximeter was performed in MR conditional environments at 1.5T and 3T. It is indicated for spot checking and/or continuous monitoring of patients who are well or poorly perfused in the MRI.

The infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -100 mmHz as the high negative pressures can result in uncontrolled fluid flow.

The MRidium 3860 MRI Infusion Pump/Monitoring System is an MRI compatible IV pump intended for use within the MR Scan room. The device shall operate to full specification in magnetic fields of up to 10,000 gauss and have RF emissions at the Larmor frequencies up to and including 3.0 Tesla MR scanners such that image signal to noise is not visibly affected with the pump within 1 foot from the MRI bore opening. The magnetic content of the device is minimal so as to avoid any hazard of magnetic attraction.

The pump unit is designed with an integral single peristaltic pump channel utilizing an ultrasonic (non-magnetic) motor. This integral channel is vertically oriented to the right side of the unit. The main assembly of the pump unit shall contain the controls, display, power supply, battery, and processor/memory functions suitable to meet the complete and expanded system requirements.

The left side of the unit is designed to accommodate attachment of an optional second peristalitic pump channel which is controlled through the main pump assembly's display and controls. A remote display is also available for independent viewing and control from the adjacent MRI Control areas.

The Dose Rate Calculator feature, allows the user to set a patient's infusion rate based upon a user selected parameters, including volume to be infused, dose, concentration, weight, and/or time.

Additionally, the Dose Rate Calculator feature with the Drug Library option, allows the user to choose a patient's infusion protocol using user selected parameters, including volume to be infused, dose, concentration, weight, and/or time. The Drug Library includes common medications most frequently infused during MRI procedures. This Drug Library option feature can only be activated with a service-related, limited user access menu.

The Pulse Oximeter feature of the 3860 MRI Infusion Pump/Monitoring System is used in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. Testing was performed in MR conditional environments at 1.5T and 3T. It is indicated for continuous monitoring of patients in the MRI who are well or poorly perfused. The 3860 System displays the patient's pulse rate and SpO2 values, as well as applicable alarm limits. The 3860 System includes adjustable audible and visual pulse rate and oxygen saturation (SpO2) alarms. It also includes a variety of additional features, including low battery alarms, status indicators and sensor-related alarms. The 3860 System only uses fiberoptic SpO2 sensors. These fiber optic sensors, cables, and associated finger wrap accessories contain no conductive components, they can safely be placed on the patient's finger while inside an MR (magnetic resonance) environment.

The provided document is a 510(k) Summary of Safety and Effectiveness for the Iradimed Corporation MRidium 3860 MRI Infusion Pump/Monitoring System. It details the device's features, intended uses, and a comparison to predicate devices. However, it does not contain a specific study demonstrating direct acceptance criteria for the device's performance as an AI/ML system, nor does it specify any performance metrics or statistical results typically found in such studies.

This document is from 2009, long before the widespread use and regulatory guidelines for AI/ML in medical devices became prevalent. It primarily focuses on demonstrating substantial equivalence to predicate devices through functional and safety testing, rather than an AI/ML specific performance study against defined acceptance criteria.

Therefore, many of the requested items regarding acceptance criteria and an AI/ML performance study cannot be filled from the provided text.

Here's an attempt to answer based on the available information, noting the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific performance metrics for the overall device's functionality (infusion pump, pulse oximeter, and MRI compatibility) as a standalone AI/ML system. Instead, it states that the device "conforms with national and available international product safety standards for medical device general safety, infusion therapy, pulse oximetry, electrical safety, and electromagnetic compatibility."

For the Pulse Oximeter feature, the document mentions:

For the Infusion Pump feature, the document mentions:

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

The document states that for the pulse oximeter feature, "both bench and clinical testing" were performed. However, it does not provide any specific sample sizes (number of patients or measurements) for this testing. The data provenance is broadly implied to be from "clinical testing" in MR environments (1.5T and 3T), but further details on country of origin or whether it was retrospective or prospective are not mentioned.

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

This information is not provided in the document. Given that the device is an infusion pump and pulse oximeter, "ground truth" would likely refer to measurements from reference devices, established physiological parameters, or clinical outcomes rather than expert consensus on interpretive tasks.

4. Adjudication Method for the Test Set

This information is not provided in the 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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as described. This type of study is relevant for AI-powered diagnostic aids where human interpretation is assisted by AI. The MRidium 3860 is a medical device for infusion and monitoring, not an AI diagnostic tool that assists human "readers".

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

The device is a hardware system for infusion and monitoring, which includes programmable features for dose calculation and drug libraries. While these features involve algorithms, the document describes them as integral functions of the pump that require human input and oversight. It is not an "algorithm-only" standalone system in the context of typical AI/ML devices where the algorithm performs an interpretive or diagnostic function independently. The testing conducted would have been performance validation of the integrated system.

7. The Type of Ground Truth Used

For the pulse oximeter, the ground truth would likely have been established using:

• Reference Instrumentation: Comparison to established, highly accurate pulse oximeters or other validated methods for measuring SpO2 and pulse rate.
• Physiological Parameters: Assessment against expected physiological responses under controlled conditions.

For the infusion pump, ground truth would involve:

• Gravimetric or Volumetric Measurements: Verifying the actual fluid delivery rate against the programmed rate using precise measurements.
• Pressure Sensors: Monitoring pump pressure to ensure safe operation.
• Electrical and Mechanical Testing: Ensuring the pump's components function within specified tolerances.

The document does not explicitly state the specific "ground truth" methods used, but these are standard for such devices.

8. The Sample Size for the Training Set

This information is not applicable/not provided in the document. The device, according to the provided text, does not appear to be an AI/ML system that undergoes a "training phase" in the conventional sense with a distinct training set of data. Its functions are based on explicitly programmed algorithms and physical principles, not learned patterns from a large dataset.

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

This information is not applicable/not provided for the reasons stated in point 8.

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