(84 days)
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:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Oxygen Saturation and Pulse Rate Measurement (SpO2) | Measures, displays, and records functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. |
| MRI Compatibility | Operates in MR conditional environments at 1.5T and 3T. |
| Patient Populations | For adult, pediatric, and infant patients. |
| Perfusion States | Indicated for continuous monitoring of patients who are well or poorly perfused. |
| Safety in MR Environment | Uses fiberoptic SpO2 sensors, cables, and finger wraps that contain no conductive components, safe for MR environment. |
For the Infusion Pump feature, the document mentions:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| MRI Compatibility (Magnetic Field) | Operates to full specification in magnetic fields up to 10,000 gauss. Magnetic content is minimal to avoid attraction hazard. |
| MRI Compatibility (RF Emissions) | Has RF emissions at 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. |
| Infusion Rate Control | Administers fluids requiring precisely controlled infusion rates (continuous, intermittent, or bolus modes). |
| Dose Rate Calculation | Allows user to set infusion rate based on volume, dose, concentration, weight, and/or time. |
| Drug Library (Optional) | Allows selection of infusion protocols using user-selected parameters; service-activated. |
| Safety (Contraindication) | Contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where negative pressure > -100 mmHz. |
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.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).