(77 days)
The Escort M8 Vital Signs Patient Monitor Model 3810 is intended for use as a vital signs monitor for adult and pediatric patients in a hospital setting.
The Escort M8 Vital Signs Patient Monitor Model 3810 is a multiparameter patient monitor intended to monitor adult and pediatric patient vital signs for general hospital use. The Escort M8 contains the hardware and software needed to perform complex data gathering and signal processing tasks that allow it to produce accurate and reliable measurements of physiological parameters such as heart rate, ECG, non invasive blood pressure, temperature, respiration, SPO2, and capnometry (eTCO2 and FiCO2), provides arrhythmia detection and displays this information on an LCD display.
The provided text describes the acceptance criteria and performance of the Escort M8 Vital Signs Patient Monitor Model 3810, which is a multiparameter patient monitor.
Here's the breakdown of the requested information:
1. Acceptance Criteria and Reported Device Performance
Note: The document primarily focuses on technical parameters and compliance with standards rather than clinical performance metrics like sensitivity/specificity for disease detection. The "Performance" is reported as Pass/Fail against specified requirements.
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General | ||
| Electrical Safety | UL 60601-1:2003, IEC 60601-1-1:2000 | Pass |
| EMC | IEC 60601-1-2 | Pass |
| Biocompatibility | ISO 10993-1 | Pass |
| Shock | IEC 60068-2-27 | Pass |
| Vibration | IEC 60068-2-64 | Pass |
| Invasive Pressure Monitoring | ||
| Measurement range | -10 to 300 mmHg | Pass |
| Measurement accuracy | ± 2 mmHg or ± 2% | Pass |
| Heart Rate Range | 30 to 240 bpm. | Pass |
| Heart Rate Accuracy | ± 4 bpm | Pass |
| Sensitivity | 5 uV/V/mmHg | Pass |
| Standard | IEC 60601-2-34: 2000 | Pass |
| Capnometer | ||
| Accuracy 0 to 20 min (0-38 mmHg) | ± 4 mmHg | Pass |
| Accuracy 0 to 20 min (39-99 mmHg) | ± 12% | Pass |
| Accuracy 20 min and up (0-38 mmHg) | ± 2 mmHg | Pass |
| Accuracy 20 min and up (39-99 mmHg) | ± 5% of reading +0.08% for every 1mmHg above 38 mmHg | Pass |
| Measurement Range | 0 to 99 mmHg ; 0 to 13.0 Vol%; 0 to 13.0 kPa | Pass |
| Flow Rate | 50ml per min. | Pass |
| Respiration Rate | 0 to 150 bpm | Pass |
| Respiration Accuracy (0-70 bpm) | ± 1 bpm | Pass |
| Respiration Accuracy (71-120 bpm) | ± 2 bpm | Pass |
| Respiration Accuracy (121-150 bpm) | ± 3 bpm | Pass |
| Standard | ISO 21647:2004 | Pass |
| Transmitter and Receiver | ||
| Frequency | Spread spectrum 902 to 928 MHz | Pass |
| Transmission | Bidirectional with seamless auto-retry | Pass |
| FCC Licensing | 47 CFR Part 15 | Pass |
| Arrhythmia Detector and Alarm | ||
| Heart Rate Range | 15 to 300 bpm. | Pass |
| Heart range accuracy | ± 2 bpm or ± 1%, whichever is greater | Pass |
| Pacer rejection | Rejects all pulses of amplitude ± 2mV to ± 700mV and duration 0.1 to 2 ms with no tail | Pass |
| Tall T-Wave rejection (Without Arrhythmia Option) | Rejects all T-Waves less than or equal to 120% of 1mV QRS. | Pass |
| Tall T-Wave rejection (With Arrhythmia Option) | Rejects T-Waves less than or equal to 60% of 1mv QRS. | Pass |
| Arrhythmia analysis | Asystole, Couplets, Bigeminy, Trigminy, Ventricular Tachycardia, Ventricular Fibrillation, Ventricular Rhythm, Ventricular runs, Multi-focal PVC's, and R-on-T. | Pass |
| Standard | AAMI/ANSI EC 57: 1998 | Pass |
| Oximeter | ||
| Saturation Range | 1% to 100% | Pass |
| Saturation Accuracy (70-100%, no motion) | ± 2 digits | Pass |
| Saturation Accuracy (70-100%, motion) | ± 3 digits | Pass |
| Saturation Accuracy (0-69%) | unspecified | Pass |
| Saturation Resolution | 1% | Pass |
| Pulse rate range | 25 to 240 Bpm | Pass |
| Pulse rate accuracy (25-240, no motion) | ± 3 digits | Pass |
| Pulse rate accuracy (25-240, motion) | ± 5 digits | Pass |
| Pulse rate resolution | 1 BPM | Pass |
| Display | ||
| Type | Color Active Matrix TFT LCD | Pass |
| Size | 8.4 in./21.3 cm diagonal | Pass |
| Resolution | 640 x 480 pixels | Pass |
| Number of Traces | 4 channels | Pass |
2. Sample size used for the test set and the data provenance
The document states: "Validation and Verification Testing confirmed that this device operates as designed and intended. The specifications for this device were verified in bench testing under simulated use conditions. Compliance to performance standards was confirmed by bench testing. This device was validated using patient simulators under simulated use conditions."
- Sample size for test set: The document does not specify a numerical sample size for "patient simulators" or "simulated use conditions." It implies that various scenarios within the specified ranges for each parameter were tested.
- Data provenance: The testing was conducted internally by the manufacturer (Invivo Corporation) as part of their validation and verification process. It's not explicitly stated if it's retrospective or prospective in detail, but standard bench and simulator validation is typically prospective for device approval. The "country of origin of the data" would implicitly be the USA, where the company is located.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this type of vital signs monitor performance testing is based on the known, precise outputs of patient simulators and calibrated measurement equipment used in bench testing, not expert consensus on interpretations of medical data.
4. Adjudication method for the test set
Not applicable. As the testing relies on objective measurements against pre-defined technical specifications, there is no need for an adjudication method by human experts.
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. This is a vital signs patient monitor, not an AI-powered diagnostic imaging device that involves human readers interpreting cases. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, effectively. The performance testing described (bench testing, patient simulators) assesses the device's algorithmic and hardware performance independently of direct human interpretation, focusing on its ability to accurately measure and display vital signs. The "Pass/Fail" results reflect the standalone performance against the technical requirements.
7. The type of ground truth used
The ground truth used for performance validation is instrumentation-based and simulated, derived from patient simulators and calibrated test equipment. This refers to precisely controlled inputs (e.g., specific blood pressure values, heart rates, SpO2 levels) generated by simulators, against which the device's measurements are compared for accuracy and precision.
8. The sample size for the training set
Not applicable. This device is a physiological patient monitor, not an AI/ML device that requires a "training set" in the context of machine learning model development. Its functionality is based on established signal processing algorithms and hardware engineering, not a learned model from a large dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this device.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.