(36 days)
The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. The 3160 MRI Patient Monitoring System is intended for use by health care professionals.
The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. It is designed to assist clinicians in monitoring patient vital signs in the MRI the dynamic and evolving Magnetic Resonance environment. A combination of wireless communication, radio frequency (RF) shielding, digital signal processing (DSP), and adaptable mounting technologies address the challenges associated with patient monitoring in the MRI area. Built on Invivo's strong heritage in MRI patient vital signs monitoring, the 3160 MRI Patient Monitoring System provides accurate, continuous, and reliable performance during all phase of MRI applications.
This document describes the 3160 MRI Patient Monitoring System, a device intended to monitor vital signs for patients during MRI procedures. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than a standalone clinical study with expert ground truth or AI performance metrics.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device's acceptance criteria are presented as "Specification" and the reported performance as "Pass" within the tables below.
| Parameter | Specification | Reported Device Performance |
|---|---|---|
| End Tidal CO2 Monitoring (Capnometer) | ||
| Measurement Range | 0-76 mmHg | Pass |
| Accuracy | ±2mmHg + 5% of reading | Pass |
| Flow Rate | 50 mL/min | Pass |
| Respiration Rate | 0 to 100 BPM | Pass |
| Zero Drift Rate | 0.5 mmHg/hr; 1.5 mmHg/24hr | Pass |
| Alarm Limits | Lower: Off, 5 to 60 mmHg; Upper: Off, 5 to 80 mmHg | Pass |
| Inspired CO2 | 25 mmHg | Pass |
| Invasive Pressure Monitoring | ||
| Channels | 1 or 2 simultaneous channels | Pass |
| Bandwidth (-3dB) | 0 to 12 Hz | Pass |
| Range | -10 to +248 mmHg | Pass |
| Sensitivity | 5 uV/V/mmHg | Pass |
| Gain Accuracy | ± 0.5 % | Pass |
| Auto Zero Feature | Zeroes with +/- 300 mmHg offset to 0+/- 5 mmHg within 1 second | Pass |
| Waveform Display Scales | 0 to 45, 0 to 75, 0 to 150, 0 to 200, 0 to 250 mmHg | Pass |
| High Pressure Alarm | 5 to 248 mmHg range; 1 mmHg resolution | Pass |
| Low Pressure Alarm | 5 to 248 mmHg range; 1 mmHg resolution | Pass |
| Temperature Monitoring | ||
| Temperature Range | 25 to 44°C (77° to 111.2°F) | Pass |
| Accuracy | ± 0.5°C (± 0.5°F) | Pass |
| Resolution | ± 0.1°C (± 0.18°F) | Pass |
| Respiration Monitoring | ||
| Range | 4 to 150 BPM | Pass |
| Resolution | 1 BPM | Pass |
| Accuracy | 2% to 60 BPM, 3.4% at 87 BPM, 5.6% at 142 BPM | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of human-reviewed data or a training/validation split common in AI/machine learning studies. The performance data is based on "Validation and Verification Testing" using simulators and test equipment.
- Sample Size: Not applicable in the context of distinct patient data sets. The testing involved "simulators and test equipment under actual use conditions" and two specific MRI scans (TRUE-FISP and PLANAR-ECHO) in a 3.0T MRI system.
- Data Provenance: Not human-derived patient data. The testing was conducted using simulators and test equipment within a specific (3.0T) MRI environment. It is a non-clinical, controlled laboratory/engineering testing environment, not retrospective or prospective patient data from a specific country.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. The performance testing described is engineering verification and validation against specified technical parameters, not a clinical study requiring expert interpretation of medical images or patient outcomes. The "ground truth" here is the known output of the simulators and test equipment against which the device's measurements are compared.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical ground truth established by experts requiring adjudication. The device's measurements were compared against known values from test equipment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission focuses on the technical performance of a vital sign monitoring device and its substantial equivalence to predicate devices, not on the improvement of human reader performance with AI assistance. The device itself is a physiological monitoring system, not an AI diagnostic tool for interpreting medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance data presented is effectively a standalone evaluation of the device's functional modules (e.g., capnometer, invasive pressure, temperature, respiration) against established technical specifications using test equipment. There is no "human-in-the-loop" component in this performance testing as described. The performance data assesses the accuracy of the device's sensors and algorithms in measuring vital signs under simulated conditions.
7. The Type of Ground Truth Used
The ground truth used for the performance testing was derived from simulators and test equipment under controlled, actual-use (MRI environment) conditions. This is a technical or engineering ground truth, where the expected values are known and precisely controlled by the testing apparatus.
8. The Sample Size for the Training Set
Not applicable. This submission describes the performance of a physiological monitoring device, not an AI or machine learning algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an AI/machine learning algorithm.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).