(62 days)
The 750E Patient Monitor is intended to continuously monitor a patients ECG, heart rate, non-invasive blood pressure (NIBP), functional arterial oxygen saturation (Sp02), respiration rate, temperature and end tidal carbon dioxide (C02). The monitor is designed as a bedside/portable monitor and is intended for use on adult, pediatric and neonatal patients in the care of health care professionals.
The CAS 750E Series Monitor, with ECG Synchronization and Mean Rate Deviation Measurement Trigger is a modification based on the existing 750E monitor. Only the 750E non-invasive blood pressure (NIBP) module portion of the multiparameter monitor is affected by the change. All other parameters of the 750E (Sp02, respiration rate, EtC02 and temperature) remain untouched. The individual module responsible for NIBP is called ND+. ECG Synchronization can use an ECG (R-wave) input signal to time correlate the occurrence of a cardiac contraction with the detection of the oscillometric blood pressure pulses occurring in a cuff wrapped around the patients upper arm. ECG Synchronization is available only when the ND+ module is operating in adult mode. ECG synchronization is taken from the edge of the ECG R-wave synchronization input signal. The delay between the subjects actual R-wave and the edge of the ECG synchronization pulse is user definable through software. This delay can be defined to be from 0 - 80ms in increments of I ms. Once set this delay must remain constant (± 5ms) throughout the blood pressure measurement. If during the NIBP measurement the ECG synchronization input stops providing pulses at a rate equal to 25 beats per minute (BPM), the ND+ module will stop using the ECG synchronization pulse to time correlate cardiac contractions with the detection of the oscillometric blood pressure pulses and complete the blood pressure measurement using only the oscillometric technique. On power-up and following a reset, ECG synchronization is disabled. The Mean Heart Rate Deviation Measurement Trigger functions while in the automatic interval measurement mode and with an ECG synchronization input present. In this mode, the Mean Heart Rate Deviation Measurement Trigger can be enabled to initiate an off-cycle blood pressure measurement when a user defined change in the subject's heart rate is detected by the ND module for a period of approximately 10 seconds. The last NIBP pulse rate measurement is compared to the current heart rate. If the current heart rate exceeds the user defined threshold, for a period of 10 seconds, an off-cycle blood pressure measurement shall be initiated. At all times there will be a minimum time between NIBP measurements of 30 seconds. The off-cycle blood pressure measurement shall restart the automatic interval timer.
The provided text describes the CAS 750E Series Monitor with NIBP modification and a study conducted to demonstrate its substantial equivalence to a predicate device. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ECG Synchronization (R-wave) Delay Adjustment | User definable from 0 - 80ms in increments of 1ms. Once set, delay must remain constant (± 5ms) throughout the blood pressure measurement. | Implicitly met, as the description details this functionality without indicating failure. |
| ECG Synchronization Disablement | If ECG synchronization input stops providing pulses at a rate of 25 BPM, the ND+ module will stop using ECG synchronization and complete measurement using oscillometric technique. | Implicitly met, as the description details this functionality without indicating failure. |
| Power-up/Reset ECG Synchronization | Disabled on power-up and following a reset. | Implicitly met, as the description details this functionality without indicating failure. |
| Mean Heart Rate Deviation Trigger | Initiate an off-cycle blood pressure measurement when a user-defined change in mean heart rate is detected for approximately 10 seconds. Thresholds: fixed value change (1-98 BPM) or percentage change (1-98%). | Implicitly met, as the description details this functionality without indicating failure. |
| Minimum Time Between NIBP Measurements | 30 seconds (even with off-cycle measurements). | Implicitly met, as the description details this functionality without indicating failure. |
| DSP and ND+ Software Evaluation | "Evaluate the DSP and ND+ software in the model 750 monitor" (VP/VR 050041). "Evaluate the DSP software in the model 750 ND+ module for HR deviation functionality" (VR/VP 060059). | "All pass" for both software evaluations. |
| NIBP Accuracy | Compliance with ANSI/AAMI SP10:2002 standard for NIBP monitors. | "Complies with SP10" (as stated in the clinical testing section). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Test Set: Not explicitly stated in terms of number of subjects or measurements within the provided text for the ANSI/AAMI SP10 study. The study refers to "Adult/Pediatric Study."
- Data Provenance: The clinical validation of the 750 monitor with the ND+ NIBP module w/ECG Gating was conducted at the University of Tennessee Medical Center. This indicates U.S. data. The text doesn't specify if it was retrospective or prospective, but clinical validation studies for medical device approvals are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth for the clinical NIBP accuracy study.
- For NIBP monitors, "ground truth" typically involves comparison against an invasively measured arterial blood pressure, often by a trained medical professional (e.g., physician, nurse, or technician) following a standard protocol.
4. Adjudication Method for the Test Set
- The document does not describe any adjudication method (like 2+1 or 3+1) for the clinical testing. For NIBP studies, ground truth is usually established directly through invasive measurements, rather than through expert consensus of subjective interpretations requiring adjudication.
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, an MRMC comparative effectiveness study was not done. This document describes a modification to a patient monitor (specifically the NIBP module) and its standalone performance against a consensus standard (ANSI/AAMI SP10). It does not involve human readers interpreting output or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone study was done for the NIBP accuracy. The clinical study (ANSI/AAMI SP10) evaluates the device's ability to accurately measure blood pressure independently, without human interaction influencing the measurement results beyond proper cuff placement and operation. The software evaluations ("VP/VR 050041" and "VR/VP 060059") are also standalone performance tests of the device's software functionality.
7. The Type of Ground Truth Used
- For the NIBP accuracy study (ANSI/AAMI SP10): The ground truth usually involves invasively measured arterial blood pressure (IBP) from a catheter placed in an artery. This is the gold standard for blood pressure measurement.
- For the software evaluations (VP/VR 050041, VR/VP 060059): The ground truth would be the expected behavior and output of the software based on its design specifications and requirements.
8. The Sample Size for the Training Set
- The document does not mention or specify a training set sample size. This is because the device described is a patient monitor with specific hardware and software functions (like ECG synchronization and heart rate deviation triggers) that are designed and verified against engineering specifications and clinical standards (like AAMI SP10). It is not an AI/Machine Learning algorithm that typically requires a large training dataset.
9. How the Ground Truth for the Training Set Was Established
- Since there is no explicit training set discussed for an AI/ML algorithm, this question is not applicable in the context of the provided information. The "ground truth" for the device's development would be its engineering specifications, design requirements, and the established medical standards it aims to meet.
§ 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).