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The Iradimed Corporation's MRidium 3870 MRI Infusion Pump System is indicated for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intravenous fluids where a large magnetic field could be present such as Magnetic Resonance Imaging (MRI). The MRidium 3870 MRI Infusion pump can also be used during transport within the clinical environment as part of the periprocedural care before or after the MRI exam. The MRidium 3870 MRI Infusion Pump can be used with up to a 3.0 Tesla MRI system when placed as close as clinically possible to the MR system, without being placed within the magnet's bore, up to a 15,000 Gauss magnetic field line.

The pump and infusion sets are designed to deliver saline and IV medication. The system is useful in the administration of fluids requiring precisely controlled infusion rates. The system can operate in primary, loading, bolus, or KVO delivery mode.

The dedicated Iradimed 1056, 1058, and 1059 Infusion Sets for the MRidium 3870 MRI Infusion Pump are intended for single patient use up to 6 hours.

The device is intended for Adult and Pediatric patients, including Neonates. Careful clinical considerations involving drug and dosing should always be applied especially with regard to neonatal subpopulations (i.e., low and extremely low birth weight).

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 MRidium 3870 MRI Infusion Pump System is indicated for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intravenous fluids where a large magnetic field could be present such as Magnetic Resonance Imaging (MRI). The MRidium 3870 MRI Infusion Pump can also be used during transport within the clinical environment as part of the periprocedural care before or after the MRI exam. The MRidium 3870 MRI Infusion Pump can be used with up to a 3.0 Tesla MRI system allowing placement as close as physically possible to the MRI scanner without being placed within the magnet's bore, up to a 15,000 Gauss magnetic field line. The magnetic content of the Pump is such that there is no hazard of magnetic attraction, up to 3T (30,000 gauss).

The pump unit is designed with an integral single peristaltic pump channel utilizing an ultrasonic (non-magnetic) motor. The integral infusion set mounting channel is horizontally oriented in the front of the pump with position detection sensors and graphical user feedback to aid the user in the correct infusion set loading process. The main assembly of the pump unit contains the controls, display, power supply, battery, and processor/memory functions suitable to meet all system requirements.

A remote display (3875) is also available as an option for independent viewing and control from the adjacent MRI Control Room area (Zone III).

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 with soft and hard limits for each drug. These Drug Library inputs can only be created or modified by the Iradimed in-house clinical team based on input and validation from the healthcare facility. Once programmed, the library is digitally signed requiring proper verification by a software 'key' within the 3870 MR IV pump upon loading. Loading of the drug library requires access to the Password protected Service Menu.

The Dose Error Reduction System (DERS) feature allows user-facilities to provide input to custom names, and doses, with hard and soft limits for use in the Drug Library. The Drug Library supports care area specific infusion protocols for primary, bolus, loading dose, and KVO delivery modes, retrievable by drug/protocol name. The library, as prescribed by the healthcare facility, is programmed with nominal starting values for: Dose, Concentration, and Time. Also, hard limits (maximum and minimum allowable) and soft limits (high and low limits that require a user confirmation to exceed) for Dose, Concentration, Time and Patient Weight can be programmed.

The provided FDA 510(k) clearance letter for the MRidium 3870 MRI Infusion Pump System focuses on demonstrating substantial equivalence to a predicate device (MRidium 3860+ MRI Infusion Pump/Monitoring System) through non-clinical performance testing. It does not describe a study involving human readers or the establishment of ground truth by expert consensus, as might be typical for AI/ML-driven medical device submissions.

Therefore, I will extract information related to the device's functional performance, which serves as its "acceptance criteria," and the "study" (non-clinical testing) that proves it meets these criteria. Many of the requested points (e.g., number of experts, adjudication methods, MRMC studies, sample sizes for training sets) are not applicable to this type of device and submission.

Here's the breakdown based on the provided document:

Acceptance Criteria and Study Proving Device Performance for MRidium 3870 MRI Infusion Pump System

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance specifications and indicates that the device meets them, primarily by demonstrating substantial equivalence to the predicate and through various verification tests. The "acceptance criteria" are implied by the specifications themselves, and the "reported device performance" is that it complies with these specifications and has been tested to perform as intended.

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The IRadimed Corporation's 3880 MRI Patient Monitoring System is intended to monitor a single patient's vital signs for patients undergoing Magnetic Resonance Imaging (MRI) procedures.

The 3880 MRI Patient Monitoring System is intended for use by healthcare professionals.

The 3880 MRI Patient Monitoring System is intended for use in Adult and Pediatric, including Neonatal populations, for monitoring of Electrocardiogram (ECG), Pulse Oximetry (SpO2), Non-Invasive Blood Pressure (NIBP), Temperature, Anesthetic Agents, Respiration, Capnography (CO2), and Oxygen (O2).

The 3880 MRI Patient Monitoring System, also referred to as the 3880, cleared October 25th, 2017, is a multi-parameter vital signs monitor designed for use in the Magnetic Resonance (MR) environment by trained healthcare professionals. The 3880 processes and displays multiple parameters, waveforms, measurement numeric values and alarms. The device is powered by either AC line power or its internal battery. It is light weight making it a practical intra-department patient transportation monitor for use within the MRI suite. The device can be carried by its handle, mounted to a wheeled cart/stand, or attached to a patient bed. The 3880 provides monitoring for the following parameters:

• Electrocardiogram (ECG) ●
• Heart rate (HR- ECG, SpO2, and NIBP derived) ●
• Blood oxygen saturation/pulse oximetry (SpO2) ●
• Non-invasive blood pressure (NIBP)
• End-tidal and fractional inspired CO2 (EtCO2 and FiCO2) ●
• Anesthetic agents (AGENTS) (requires 3886 Multi-Gas Unit) ●
  • Desflurane (DES) O
  • Enflurane (ENF) O
  • Halothane (HAL) O
  • Isoflurane (ISO) O
  • Sevoflurane (SEV) O
• Fractional inspired O2 (FiO2), and end-tidal and fractional inspired N2O (EtN2O and FiN2O) ● (requires 3886 Multi-Gas Unit)
• Temperature (TEMP) ●
• Respiration rate (CO2-derived) ●

The provided text describes a 510(k) premarket notification for the Iradimed Corporation's 3880 MRI Patient Monitoring System. The purpose of this submission is to expand the indications for use to include neonatal populations for Pulse Oximetry (SpO2), Capnography (CO2), and Anesthetic Agents (AGENTS). The manufacturer claims substantial equivalence to previously cleared devices.

Based on the provided text, the device itself is a patient monitoring system, and the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the non-clinical and potentially clinical testing performed to demonstrate substantial equivalence for the expanded indications.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by conformance to FDA-recognized consensus standards for medical electrical equipment. The "reported device performance" is indicated by a "Pass" for each standard.

Notes from the document:

• *All FDA Recognized Consensus Standards test reports listed above were provided and reviewed with the primary predicate device, which was cleared to market under K172200. The test reports provided in this submission, identified with asterisks in the table above, have been supplied in Section 18 to support substantial equivalence with the parameter specific predicates for the SpO2 and CO2/AGENTS parameters.
• ** Additional bench testing comparing performance of the Masimo SET Rad 8 was conducted to demonstrate equivalence of the subject device which integrates Masimo MS Series Module and sensor technology. The testing demonstrated equivalence of both systems when configured for use in neonates.

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

The document explicitly states: "The proposed modifications to the 3880 MRI Patient Monitoring Systems labeling does not require non-clinical performance testing. The non-clinical performance testing provided in K172200 has not changed since the submission and is still applicable to the modified device."

• Sample Size for Test Set: Not directly specified in the provided text for the current submission (K180903). The reliance is on prior testing from K172200 and the specified predicate devices (K050399, K053269, K171121). For the SpO2 performance, "The SpO2 volunteer blood study testing results using ISO 80601-2-61:2011 were submitted with K172200." This suggests human subject data for SpO2 accuracy, but the sample size is not stated here. "Additional bench testing comparing performance of the Masimo SET Rad 8 was conducted" for neonatal SpO2, but again, the sample size (e.g., number of test points, subjects) is not provided.
• Data Provenance: The data is primarily from non-clinical performance testing (bench testing) and possibly a volunteer blood study. The origin (country, retrospective/prospective) of this data is not specified, but typically, premarket testing for FDA clearance is conducted under good laboratory practices (GLP) and may involve international standards but is intended for the US regulatory context. The nature of the submission (510(k) for an expanded indication) suggests this isn't a large-scale clinical trial with geographical data.

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

This type of information is typically relevant for studies involving subjective interpretations (e.g., image analysis for AI diagnostic devices). For a vital signs monitor, the "ground truth" would be established by validated reference measurement devices or controlled physiological conditions. The document does not describe the use of experts to establish ground truth in the way one would for diagnostic imaging.

4. Adjudication Method for the Test Set

Not applicable in the context of this submission. Adjudication methods (e.g., 2+1, 3+1) are common in studies where multiple human readers assess cases and their disagreements need to be resolved to establish a "ground truth" or reference standard. For a vital signs monitor, the performance is typically assessed against a known standard or reference measurement, not through human consensus.

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

No, an MRMC comparative effectiveness study was not done. This type of study is primarily for diagnostic medical devices (e.g., AI for radiology) to compare the performance of human readers with and without AI assistance. This submission is for a vital sign monitoring system, and the equivalence is established through conformance to performance standards and comparison to predicate devices, not improvement in human reader performance.

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

The device is a patient monitoring system, which intrinsically involves a human-in-the-loop (healthcare professional) for operation and interpretation. The "performance" refers to its accuracy and reliability in measuring physiological parameters, which is assessed against objective standards, not as a standalone AI algorithm independent of human use. The performance data is essentially "standalone" in the sense that the device's measurements are validated against reference measurements, assuming correct operation by a human, but it's not an AI algorithm in the typical sense of generating a diagnosis or recommendation.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on:

• Validated Reference Measurement Devices: For parameters like SpO2, NIBP, temperature, CO2, and anesthetic agents, the "ground truth" is typically obtained from highly accurate, calibrated reference instruments under controlled conditions (e.g., volunteer blood study for SpO2, calibrated pressure sources for NIBP, known gas concentrations for CO2/agents).
• Consensus Standards: Conformance to recognized international and national standards (e.g., ISO 80601 series) dictates the methods for validation and the acceptable ranges of error, effectively serving as the definition of acceptable "ground truth" performance.

8. The Sample Size for the Training Set

The provided document does not mention "training sets" in the context of machine learning or AI algorithms. This device is a physiological monitor, not an AI/ML-based diagnostic or prognostic tool. Therefore, there is no "training set" in the sense of data used to train an algorithm. The development of such devices relies on engineering design, validation against physical and physiological models, and adherence to established measurement principles, not data-driven machine learning.

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

As there is no mention of an AI/ML training set, this question is not applicable.

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The IRadimed Corporation's 3880 MRI Patient Monitoring System is intended to monitor a single patient's vital signs for patients undergoing Magnetic Resonance Imaging (MRI) procedures. The 3880 MRI Patient Monitoring System is intended for use by healthcare professionals. The 3880 MRI Patient Monitoring System is intended for use in Adult and Pediatic, including Neonatal populations, for monitoring of Electrocardiogram (ECG), Non-Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) and Temperature. The 3880 MRI Patient Monitoring System is also intended for use in Adult and Pediatric, not including Neonatal populations, for monitoring of Pulse Oximetry (SpO2), Anesthetic Agents, Respiration, Capnography (CO2) and Oxygen (O2). The 3880 MRI Patient Monitoring System provides monitoring for three distinct patient types as defined below (Note: Pediatric group excludes Neonates):

1 - Adult (greater than 22 years).
2 - Pediatric (Infant 29 days - 2 years), Child (2 - 12 years), Adolescent (12 - 21 years),
3 - Neonate (28 days).

The 3880 MRI Patient Monitoring System, also referred to as the 3880, is a multi-parameter vital signs monitor designed for use in the Magnetic Resonance Imaging (MRI) environment by trained healthcare professionals. The 3880 processes and displays multiple parameters, waveforms, measurement numeric values and alarms. The device is powered by either AC line power or its internal battery. It is light weight making it a practical intra-department patient transportation monitor for use within the MRI suite. The device can be carried by its handle, mounted to a wheeled cart/stand, or attached to a patient bed. The 3880 provides monitoring for the following parameters: Electrocardiogram (ECG), Heart rate (HR- ECG, SpO2, IBP and NIBP derived), Blood oxygen saturation/pulse oximetry (SpO2), Non-invasive blood pressure (NIBP), Invasive blood pressure (IBP), End-tidal and fractional inspired CO2 (EtCO2 and FiCO2), Anesthetic agents (AGENTS) (requires 3886 Multi-Gas Unit) - Desflurane (DES), Enflurane (ENF), Halothane (HAL), Isoflurane (ISO), Sevoflurane (SEV), Fractional inspired O2 (FiO2), and end-tidal and fractional inspired N2O (EtN2O and FiNzO) . (requires 3886 Multi-Gas Unit), Temperature (TEMP), Respiration rate (CO2-derived).

The document provided is a 510(k) premarket notification for the IRadimed Corporation's 3880 MRI Patient Monitoring System, specifically for the addition of Invasive Blood Pressure (IBP) monitoring. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria with clinical studies. As such, much of the requested information (like sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) is not explicitly provided in the context of proving performance against numerical acceptance criteria using clinical data for the IBP feature.

However, the document does contain information about performance testing against recognized consensus standards. Here's a breakdown of what can be extracted:

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

The document does not present specific numerical acceptance criteria for IBP performance (e.g., accuracy +/- X mmHg) directly within a table. Instead, it indicates compliance with recognized consensus standards. For IBP, the relevant standard mentioned is:

This implies that the device met all the requirements outlined in this standard for invasive blood pressure monitoring. The detailed numerical specifications within this standard would constitute the acceptance criteria.

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 explicitly states: "Clinical data is not required to substantiate claims of safety and effectiveness for the modification of the proposed device to include invasive blood pressure monitoring." Therefore, no sample size for a clinical test set is provided, nor is data provenance from such a study. The performance evaluation relied on non-clinical (laboratory/engineering) testing against standards.

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, as no clinical study with expert-established ground truth was performed for the IBP addition.

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

Not applicable, as no clinical study requiring adjudication was performed for the IBP addition.

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. The device is a patient vital signs monitor, not an AI diagnostic tool used by human readers. Its function is to display vital signs, not to interpret images or aid human decision-making in a way that an MRMC study would assess.

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

The performance of the IBP monitoring functionality was assessed in a "standalone" fashion in the sense that the device's ability to measure and display IBP was evaluated against engineering standards without requiring human interpretation as part of the primary performance evaluation. The "Pass" result for IEC 60601-2-34 indicates it met the specified performance requirements of this standard.

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

For the non-clinical performance evaluation, the "ground truth" would be the reference measurements or established benchmarks against which the device's IBP readings were compared in a controlled laboratory setting, as mandated by the IEC 60601-2-34 standard. This standard specifies methods for testing the accuracy and performance of invasive blood pressure monitors.

8. The sample size for the training set

Not applicable. The device is a monitoring system, not an AI algorithm that undergoes a training phase with a dataset.

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

Not applicable, as no training set was used for an AI algorithm.

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The IRadimed Corporation's 3880 MRI Patient Monitoring System is intended to monitor a single patient's vital signs for patients undergoing Magnetic Resonance Imaging (MRI) procedures.

The 3880 MRI Patient Monitoring System is intended for use by healthcare professionals.

The 3880 MRI Patient Monitoring System is intended for use in Adult and Pediatric, including Neonations, for monitoring of Electrocardiogram (ECG). Non-Invasive Blood Pressure (NIBP), and Temperature.

The 3880 MRI Patient Monitoring System is also intended for use in Adult and Pediatric. not including Neonatal populations, for monitoring of Pulse Oximetry (SpO2), Anesthetic Agents, Respiration, Capnography (CO2), and Oxygen (02).

The 3880 MRI Patient Monitoring System provides monitoring for three distinct patient types as defined below (Note: Pediatric group excludes Neonates):

The 3880 MRI Patient Monitoring System, also referred to as the 3880, is a multi-parameter vital signs monitor designed for use in the Magnetic Resonance (MR) environment by trained healthcare professionals. The 3880 processes and displays multiple parameters, waveforms, measurement numeric values and alarms. The device is powered by either AC line power or its internal battery. It is light weight making it a practical intra-department patient transportation monitor for use within the MRI suite. The device can be carried by its handle, mounted to a wheeled cart/stand, or patient bed. The 3880 provides monitoring for the following parameters:

• Electrocardiogram (ECG)
• Heart rate (HR- ECG, SpO2, and NIBP derived)
• Blood oxygen saturation/pulse oximetry (SpO2)
• Non-invasive blood pressure (NIBP)
• End-tidal and fractional inspired CO2 (EtCO2 and FiCO2)
• Anesthetic agents (AGENT) (requires 3886 Multi-Gas Unit)
  • Desflurane (DES)
  • Enflurane (ENF)
  • Halothane (HAL)
  • Isoflurane (ISO)
  • Sevoflurane (SEV)
• Fractional inspired O2 (FiO2), and end-tidal and fractional inspired N2O (EtN2O and FiN2O) (requires 3886 Multi-Gas Unit)
• Temperature (TEMP)
• Respiration rate (CO2-derived)

The 3880 MRI Patient Monitoring System can be ordered with the following configurations:

Standard Configuration:

Optional Configuration (Requires 3880 and 3886):

The 3880 consists of the following key components:

• Patient monitor with buttons and touch screen display
• Wireless ECG POD, "ePOD"
• Wireless SpO2 POD, "oPOD"
• Battery for patient monitor
• Power supply and cables
• Operation Manual

Accessories to the 3880 are offered to accommodate various patient sizes. Key standard and optional accessories include:

• ECG cables and electrodes
• SpO2 sensors and grips
• NIBP cuffs and hoses
• Temperature sensor
• Cannulas
• Remote monitoring tablet (3885-T)
• Remote monitoring tablet docking base, including printer (3885-B)
• Multi-Gas Unit (3886)
• Mounting hardware and stand

The provided text is a 510(k) summary for the IRadimed Corporation's 3880 MRI Patient Monitoring System. It focuses on demonstrating substantial equivalence to a predicate device, the MIPM Tesla M3 MRI Patient Monitoring System (K142032). The device performance is primarily established through non-clinical testing and conformance to recognized consensus standards, with limited clinical data for a specific function.

Here's an analysis based on your requested information:

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

The document does not explicitly present a table of "acceptance criteria" for overall device performance in the way one might expect for a diagnostic AI device (e.g., predefined sensitivity/specificity thresholds). Instead, the acceptance criteria are implicitly tied to conformance with various recognized consensus standards (largely related to safety, essential performance, and electromagnetic compatibility) and functional equivalence to the predicate device. For the NIBP function specifically, the acceptance criterion was meeting the requirements of ISO 81060-2.

Here's a summary derived from the "SUMMARY OF NON-CLINICAL PERFORMANCE DATA" and "SUMMARY OF CLINICAL PERFORMANCE DATA" sections within the provided text:

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

The document mentions "clinical performance data provided in Section 20" for NIBP. However, Section 20 is not included in the provided text. Therefore, details regarding the sample size, data provenance (country of origin, retrospective/prospective nature) for the NIBP clinical test set are not available in this document.
For the non-clinical performance data, the "test set" would refer to the physical devices and simulated conditions used for testing against the consensus standards. No sample sizes are specified for these tests. Their provenance is implied to be IRadimed Corporation's testing facilities.

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 section is not applicable in the context of this 510(k) submission. The 3880 MRI Patient Monitoring System is a vital signs monitor, not a diagnostic imaging AI device. Its performance is evaluated against physiological measurement accuracy standards and safety/performance standards, not against expert consensus on images. For the NIBP clinical data, the "ground truth" would be established by a reference NIBP measurement method, not human experts evaluating images.

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

This is not applicable for this device type and evaluation. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human readers of diagnostic images where consensus among experts is needed to establish ground truth for ambiguous cases. This device measures physiological parameters.

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 3880 MRI Patient Monitoring System is a vital signs monitor and does not involve AI assistance for human readers of diagnostic images. Therefore, an MRMC comparative effectiveness study is not relevant to its regulatory submission.

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

The device itself is a standalone vital signs monitor. Its performance in measuring vital signs (ECG, NIBP, SpO2, Temperature, CO2, Anesthetic Agents, O2) is assessed as an algorithm/device-only performance in relation to established physiological measurement standards. The non-clinical testing referenced demonstrates this standalone performance. The NIBP clinical study also evaluates the device's standalone accuracy against a reference.

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

For the non-clinical performance testing (conformance to IEC/ISO standards), the "ground truth" is effectively the defined specifications and measurement accuracy requirements within those standards. These are objective, measurable criteria.
For the NIBP clinical validation, the ground truth would be established by a reference method for blood pressure measurement, as per ISO 81060-2. This standard specifies how clinical validation should be performed and what constitutes an accurate reference measurement.

8. The sample size for the training set

This information is not applicable. The 3880 MRI Patient Monitoring System is a traditional medical device (vital signs monitor) and not an AI/Machine Learning device that undergoes a "training" phase with a dataset in the conventional sense. Its design and performance are based on engineering principles and compliance with established standards, not on learning from a large dataset.

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

This information is not applicable for the same reason 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 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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The Iradimed Corporation's MRIDIUM 3850 Infusion Pump System is intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with 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 specific MRidium 3850 Series MRI Infusion Pump System (including the MRidium 1000 Series of Infusion Sets) indications for use are as follows:

1. Useful in the administration of fluids requiring precisely controlled infusions and including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
2. Useful in the following delivery routes: arterial, intravenous, spinal, subcutaneous, and enteral.
3. Useful in the following delivery modes: continuous, intermittent and bolus.
4. Although specifically intended for use in the MRI, this product can be useful in critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the pump can be monitored or supervised by a clinician.
5. Used inside the MRI room mounted outside the 10,000 Gauss line and with MRI magnets of field strength of 3.0 Tesla or less.

The MRidium 1000 Series Infusion Sets are intended as accessories to the MRidium 3850 Series MRI Infusion Pump for use in the administration of fluids for precisely controlled infusion rates.

The infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -250 mmHg and could result in uncontrolled fluid flow.

The MRidium 3850 MRI Infusion Pump 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 the 10.000 gauss-line of a 3.0 Tesla MR Scanner, 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 peristaltic pump channel which is controlled through the main pump assembly's display and controls.

The MRidium 1000 Series Infusion Sets utilize medical-grade PVC tubing with a medical-grade silicone rubber pumping segment that fits into a custom housing within the Pump. These Infusion Sets also contain the necessary flow stop/prevention devices, needle-free access ports, and fluid bottle/bag insertion devices required for safe and effective fluid delivery.

The provided text describes a 510(k) premarket notification for the MRidium™ 3850 Infusion Pump System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's absolute performance against established acceptance criteria for a novel technology. Therefore, many of the requested elements (like effect size of human readers with AI, adjudication methods for ground truth, or specific details of a comparative effectiveness study) are not applicable or directly derivable from this type of regulatory submission.

However, based on the provided text, here’s an interpretation of the available information:

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

The document doesn't explicitly list "acceptance criteria" in a typical quantitative, pass/fail table format as would be seen for a new, unproven technology. Instead, it refers to conformity with national and international product safety standards and functional equivalence to predicate devices. The "performance" is primarily demonstrated through meeting these standards and showing that its technology is comparable.

• Uses a piezo-electric/ultrasonic motor, which possesses inherent MRI-compatibility due to its immunity to magnetic fields. |
  | - RF emissions at Larmor frequencies up to 3.0 Tesla MR scanners such that image signal-to-noise ratio is not visibly affected with the pump within 1 foot of the MR bore opening. | - "...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 MR bore opening." |
  | - Minimal magnetic content to avoid hazard of magnetic attraction. | - "The magnetic content of the device is minimal so as to avoid any hazard of magnetic attraction." |
  | Functional Equivalence to Predicates: | "The MRidium™ 3850 MRI Infusion Pump System (including the MRidium 1000 Series Infusion Sets) is functionally identical and substantially equivalent to the Medrad Continuum MRI-Compatible System and Alaris PC-1 Infusion System..."
• Similar in: Patient Infusion Sets, AC/Battery Power Systems, Pump Drive and Control System, Air Bubble Detection System, Fluid Overpressure Limit System, Alarm Detection System, Keypad/Information Display System, Communication System. |
  | Compliance with Safety Standards: | |
  | - Conforms to national and international product safety standards for infusion therapy, electrical safety, and electromagnetic compatibility. | - "conforms with national and available international product safety standards for infusion therapy, electrical safety, and electromagnetic compatibility. Nonclinical testing has been performed using these standards to establish the device's performance. These include: IEC 60601-1-1; IEC60601-1-2; AAMI/ANSI ID26 (1998); IEC 60601-2-24; and UL2601." |
  | - Mitigation of identified potential hazards. | - "Additionally, tests demonstrating consideration and mitigation of the identified potential hazards for this device were completed, along with the design reviews, prior to product release." |

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

The document does not specify a "test set" in the context of clinical data or patient samples. The testing described is non-clinical testing based on engineering standards. Therefore, concepts like country of origin for data or retrospective/prospective don't apply here. The "sample size" would refer to the number of devices or components tested according to the listed standards. This is not explicitly stated but implied by the successful completion of the tests.

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

This information is not provided because the "ground truth" for this type of regulatory submission is typically defined by established engineering and medical device safety standards (e.g., IEC 60601 series, AAMI/ANSI ID26, UL2601), not by expert clinical consensus on a specific dataset.

4. Adjudication method for the test set

Not applicable. The testing described is non-clinical, hardware/software performance validation against standards, not clinical data 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 not a study involving human readers or AI assistance. It's a 510(k) submission for an infusion pump, establishing substantial equivalence to existing predicate devices.

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

This concept is not directly applicable. The device is an infusion pump, and its "standalone performance" is assessed by its ability to meet the specified engineering and safety standards, and to perform its intended function equivalently to predicate devices. There isn't an "algorithm only" component in the context of a diagnostic or AI-driven decision support system.

7. The type of ground truth used

The "ground truth" here is embodied in:

• Established engineering and medical device safety standards: (e.g., IEC 60601-1-1, IEC60601-1-2, AAMI/ANSI ID26 (1998), IEC 60601-2-24, and UL2601).
• Functional specifications of predicate devices: The functionality of the Medrad Continuum Infusion Pump System and Alaris PC-1 Infusion System serves as a benchmark for equivalence.
• Physical laws and principles related to MRI compatibility (magnetic fields, RF emissions).

8. The sample size for the training set

Not applicable. The device is an infusion pump, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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