(31 days)
The 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 MRI Patient Monitoring System (Model 865214) is intended for use by healthcare professionals.
The modified device, MRI Patient Monitoring System (Model 865214), is substantially equivalent to the cleared device. Both devices are multi-parameter patient monitors intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. Both devices provide patient monitoring data for ECG. SpO2, respiration, non-invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature, oxygen (O2), end-tidal carbon dioxide (EtCO2), and anesthetic agents. The modifications to the cleared device are only in regards to the temperature parameter, specifically the reusable temperature sensor.
Here's a breakdown of the acceptance criteria and study information for the Invivo MRI Patient Monitoring System (Model 865214), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Cleared Device) | Modified Device Performance (Acceptance Criteria) |
|---|---|---|
| Temperature Accuracy (outside MR bore) | ±0.5℃ (±0.9ºF) | ±0.5℃ (±0.9ºF) |
| Temperature Accuracy (inside MR system magnet bore) | ±0.5℃ (±0.9ºF) (Implied, as this was the previous spec for the single-use sensor) | Up to a -0.5℃ shift (-1.0℃ to 0.0°C, -1.8°F to 0.0°F) |
Note: The document explicitly states that the modifications only pertain to the temperature parameter, specifically the reusable temperature sensor. Therefore, the acceptance criteria and performance for other vital signs (ECG, SpO2, NIBP, IBP, end-tidal CO2 (ETCO2), oxygen (O2), and anesthetic agents) are presumed to remain unchanged from the cleared device and are not detailed in this submission as they were not re-evaluated.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the "sample size" in terms of number of patients or individual measurements for the performance verification tests. It refers generally to "results of the complete verification and validation" for performance specifications and "the modified device's reusable temperature sensor was evaluated" for MRI conditions of use.
- Data Provenance: The studies were conducted by Invivo Corporation as part of their verification and validation process for the modified device. The studies were likely internal, prospective tests, rather than retrospective analysis of patient data. The country of origin for the data is not specified, but the manufacturer is based in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. The ground truth for this device modification (temperature sensor accuracy) was established against calibrated reference standards and physical measurements, not through expert consensus on medical images or clinical observations.
4. Adjudication Method for the Test Set
- Not Applicable. As the ground truth was established through physical measurements and calibrated equipment, an adjudication method for human reviewers is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This was not an MRMC study. The device is a physiological monitor, not a diagnostic imaging device requiring human interpretation for its primary function. Its performance was assessed against technical specifications and standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes. The performance evaluation was a standalone assessment of the device's measurement capabilities. There is no "human-in-the-loop" performance being evaluated in this context. The device directly measures physiological parameters.
7. The Type of Ground Truth Used
- Calibration Standards and Physical Measurements: For temperature accuracy, the ground truth would have been established using highly accurate, calibrated temperature reference devices and control environments (e.g., water baths, environmental chambers). For MRI conditions of use, physical measurements and established protocols (e.g., using a thermocouple for RF heating, measuring displacement force in a magnetic field) would have constituted the ground truth.
8. The Sample Size for the Training Set
- Not Applicable. This is a hardware device modification and its performance was evaluated through engineering verification and validation, not through machine learning or AI models that require training data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. (See point 8).
§ 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).