(267 days)
The Expression MRI Patient Monitoring System (Model 865214) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. The Expression MRI Patient Monitoring System (Model 865214) is intended for use by healthcare professionals.
The Expression MRI Patient Monitoring System (Model 865214) is designed to assist clinicians in monitoring patient vital signs in the midst of the dynamic and evolving magnetic resonance (MR) 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 MR environment. The Expression MRI Patient Monitoring System (Model 865214) includes monitoring capabilities for wireless electrocardiogram (ECG), wireless pulse oximetry (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature, respiration, end-tidal CO2 (EtCO2), oxygen, and anesthetic agents.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance Study for Expression MRI Patient Monitoring System (Model 865214)
1. Table of Acceptance Criteria and Reported Device Performance
The device underwent verification and validation testing of its performance specifications. The results are summarized below:
| Parameter | Specification | Reported Device Performance (Conclusion) |
|---|---|---|
| Pulse Oximetry (SpO2) | ||
| Saturation Range | 1-100% | Pass |
| Saturation Accuracy | ± 3% at 70-100% | Pass (ARMS specification of 3 for 70-100% saturation) |
| Pulse Rate Range | 30-250 BPM | Pass |
| Pulse Rate Accuracy | ± 2% or 1 BPM, whichever is greater | Pass |
| Temperature | ||
| Measurement Range | 20-44°C | Pass |
| Accuracy | ±0.5°C | Pass |
| Anesthetic Agents Monitoring | ||
| Measurement Range | ||
| Halothane | 0-5.0 Vol% | Pass |
| Enflurane | 0-5.0 Vol% | Pass |
| Isoflurane | 0-5.0 Vol% | Pass |
| Sevoflurane | 0-8.0 Vol% | Pass |
| Desflurane | 0-18.0 Vol% | Pass |
| CO2 | 0-10.0 Vol% | Pass |
| Nitrous Oxide | 0-100% | Pass |
| Accuracy | Halothane: ±0.15 Vol% at 0-1.00 Vol%, ±0.20 Vol% at 1.00-5.00 Vol% | Pass |
| Enflurane: ±0.15 Vol% at 0-1.00 Vol%, ±0.20 Vol% at 1.00-5.00 Vol% | Pass | |
| Isoflurane: ±0.15 Vol% at 0-1.00 Vol%, ±0.20 Vol% at 1.00-5.00 Vol% | Pass | |
| Sevoflurane: ±0.15 Vol% at 0-1.00 Vol%, ±0.20 Vol% at 1.00-5.00 Vol%, ±0.40 Vol% at 5.00-8.00 Vol% | Pass | |
| Desflurane: ±0.15 Vol% at 0-1.00 Vol%, ±0.20 Vol% at 1.00-5.00 Vol%, ±0.40 Vol% at 5.00-10.00 Vol%, ±0.60 Vol% at 10.0-15.0 Vol%, ±1.0 Vol% at 15.0-18.0 Vol% | Pass | |
| CO2: ±0.10 Vol% at 0-1.00 Vol%, ±0.20 Vol% at 1.00-5.00 Vol%, ±0.30 Vol% at 5.00-7.00 Vol%, ±0.50 Vol% at 7.00-10.00 Vol% | Pass | |
| Flow rate | Adult mode: 200mL/min (+/-20mL/min); Neonatal mode: 150mL/min (+/-15mL/min) | Pass |
| Respiration Rate | 2 - 60 rpm (+/-1 rpm) | Pass |
| Auto ID Threshold | (Primary agent ID) 0.15% | Pass |
| Zero Drift Rate | Automatically zeroes at least every four hours or for every ±1°C temperature change from the last stored stable operating temperature | Pass |
| Display Resolution | 0.1% Volume | Pass |
| Multiple Agents Alarm Threshold | Upon detection of more than one agent of >0.15 Vol% | Pass |
MRI Susceptibility (MR Compatibility):
- 1.5T MR Imaging System (T1W FFFE, T1W IR, T2W SE EPI scans): Met performance specifications.
- 3.0T MR Imaging System (T1W FFE, T1W IR TSE, T2W SE EPI scans): Met performance specifications.
- Conditions of use (static magnetic field strength, specific absorption rate, scan duration, gradient field switching rate, device proximity to the magnet bore): Met MR conditions of use stated in labeling.
The document also mentions compliance with various voluntary standards for safety and performance (e.g., IEC 60601 series, ANSI/AAMI, ASTM, ISO) and hazard analysis/risk management (ISO 14971), all of which were "Pass."
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size used for the test set in the performance specification verification and validation. It mentions:
- General Performance Verification: "All patient monitoring parameters of the Expression MRI Patient Monitoring System (Model 865214) were verified according to the performance specifications."
- SpO2 Accuracy Validation: "Pulse oximetry (SpO2) accuracy... compared to arterial blood CO-oximetry for validation."
The data provenance is not specified (e.g., country of origin, retrospective or prospective), but the tests appear to be laboratory-based verification and validation studies using "patient simulators and test equipment" under "worst-case environment" and "actual use conditions."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set. For the SpO2 accuracy, the ground truth was established by "arterial blood CO-oximetry." For other physiological parameters, the ground truth was likely derived from calibrated test equipment or patient simulators.
4. Adjudication Method for the Test Set
No adjudication method is mentioned, as the testing described is primarily objective verification against predetermined specifications (e.g., "Pass" or "Fail" based on whether the device met the numerical specifications).
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 MRMC study was reported. This device is a physiological patient monitor, not an AI-assisted diagnostic tool, so such a study would not be applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance testing described ("Verification and Validation of Performance Specifications" and "Validation of SpO2 Accuracy") represents standalone algorithm performance through testing the output specifications of the device against known inputs from simulators or blood analyses. Human interaction is for setup and interpretation, but the core measurement and display of parameters is algorithmic.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- SpO2 Accuracy: Arterial blood CO-oximetry.
- Other Physiological Parameters (Temperature, Pulse Rate, Anesthetic Agents, CO2, Respiration Rate): Implied to be established by calibrated reference standards, patient simulators, or test equipment.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning. The device's underlying technology and algorithms for physiological monitoring are based on established scientific principles and engineering, not a machine learning training paradigm.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for machine learning, this question is not applicable. The device's functionality relies on established physiological measurement principles.
§ 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).