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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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