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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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