(449 days)
The North-vision Elegant-1000 Series of Multi-parameter Patient Monitor are intended to monitor, display and record physiological signs of adult, pediatric patients. With the functions of near real-time recording and displaying parameters ECG, heart rate, non-invasive blood pressure, functional oxygen saturation, it allows comprehensive analysis of patient's physiological conditions. This apparatus is applicable for use in hospitals, clinics, and practitioner's office. The operation should be carried out by qualified professionals only.
The Elegant-1000 Series are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. They are modular designed patient Monitors. They can monitor the patient's Electrocardiograph (ECG) by measuring physical parameters with variety modules. It can also measure non-invasive blood pressure (NIBP) including systolic, diastolic and mean by oscillating method. It can detect the blood oxygen saturation (SpO2) and pulse rate (PR) by the photoelectric method. The accessories and the sensors will transfer the physical parameters into electrical signal, which will be collected and amplified by the circuit in the device. After CPU analyzing and calculating the parameters are displayed on the screen in a graphical representation and it can record and/or print if necessary. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.
Let's break down the information regarding the acceptance criteria and the study that proves the device meets them, based on the provided text.
The document discusses the North-vision Elegant-1000 Series of Multi-parameter Patient Monitor. This device monitors and displays various physiological signs like ECG, heart rate, non-invasive blood pressure (NIBP), and functional oxygen saturation (SpO2) for adult and pediatric patients.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the North-vision Elegant-1000 Series are primarily defined by adherence to various international standards for medical electrical equipment. The reported device performance is indicated by the "Passed" status for each test.
| Parameter/Test | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| General Safety & Performance | ||
| Electrical Safety | Compliance to IEC 60601-1:2012 | Passed |
| Electromagnetic Compatibility | Compliance to IEC 60601-1-2:2007 | Passed |
| Multifunction Patient Monitor | Compliance to EN 60601-2-49:2001 | Passed |
| Alarms | Compliance to IEC 60601-1-8:2012 | Passed |
| Biocompatibility | Compliance to ISO 10993-1:2009 | Passed |
| Risk Management | Compliance to ISO 14971:2012 | Passed |
| Software | Compliance to IEC 62304:2015 | Passed |
| Usability | Compliance to IEC 62366:2014 | Passed |
| Batteries | Compliance to IEC 62133 | Passed |
| ECG Trunk Cables & Leadwires | Compliance to ANSI/AAMI EC53:2013 | Passed |
| Specific Physiological Parameters | ||
| ECG | Compliance to IEC 60601-2-27:2011 | Passed |
| Pulse Oximeter (SpO2) | Compliance to ISO 80601-2-61:2011 | Passed |
| NIBP | Compliance to IEC 80601-2-30:2013, ANSI/AAMI/ISO 81060-2:2013 | Passed |
Additional Performance Specifications (Compared to Predicate Device for Equivalence):
| Parameter | Predicate Device (SHENZHEN CREATIVE UP-7000) Performance | North-vision Elegant-1000 Series Performance (Elegant-1100, -1080, -1070) | Equivalence Assessment |
|---|---|---|---|
| NIBP Measuring Range | Systolic: 40-255mmHg | ||
| Diastolic: 10-195mmHg | |||
| Mean: 21-215mmHg | Systolic: 20-290mmHg | ||
| Diastolic: 10-260mmHg | |||
| Mean: 15-275mmHg | Equivalent, but North-vision has wider range | ||
| NIBP Measuring Accuracy | Systolic: ±5 mmHg | ||
| Diastolic: ±5 mmHg | |||
| MAP: ±5 mmHg | Systolic: ±5 mmHg | ||
| Diastolic: ±5 mmHg | |||
| MAP: ±5 mmHg | Equivalent | ||
| SpO2 Measuring Range | 35-100% | 0-100% | Equivalent, but North-vision has wider range |
| SpO2 Measuring Accuracy | 70-100%: ±3% | 70-100%: ±2% | Equivalent, but North-vision has better accuracy |
| SpO2 Pulse Rate Measuring Range | 30-240bpm | 15-300bpm | Equivalent, but North-vision has wider range |
| SpO2 Pulse Rate Accuracy | ±2bpm | ±2bpm | Equivalent |
| ECG Heart Rate Measuring Range | 15-350bpm(±2bpm) | 10-300bpm(±2bpm) - Note: Table on page 5 shows 10-300bpm, table on page 8 shows 15-300bpm. Using 15-300bpm for consistency with general trend of being equivalent or better compared to predicate. | Equivalent |
| ECG Sensitivity Selection | x1/2, x1, x2, x4, Auto | x1/4, x1/2, x1, x2, x4, Auto | Equivalent, but North-vision has one more selection (x1/4) |
2. Sample Size Used for the Test Set and Data Provenance
The document states that clinical testing for NIBP and SpO2 functionality was completed to validate clinical accuracy. However, it does not specify the sample size used for this clinical test set for NIBP and SpO2, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective).
For the non-clinical tests, these typically involve lab-based testing of the device itself rather than patient data, so direct sample size for a "test set" in the context of patient data is not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document mentions "clinical testing for conformance," which implies ground truth was established clinically. However, it does not specify the number of experts used or their qualifications for establishing ground truth in the clinical studies for NIBP and SpO2.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the clinical test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, the document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the device's standalone performance compared to industry standards and general equivalence to a predicate device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies described are primarily standalone performance studies of the device. The non-clinical tests evaluate the device's adherence to various technical and safety standards. The clinical tests for NIBP and SpO2 evaluate the device's accuracy in measuring these parameters, inherently a standalone performance assessment against clinical ground truth. There is no indication of a human-in-the-loop component in the described testing.
7. The Type of Ground Truth Used
For the NIBP and SpO2 clinical performance, the ground truth was implied to be clinical accuracy as determined by reference methods during the clinical testing for conformance with ANSI/AAMI 81060-2:2013 and ISO80601-2-61: 2011. These standards typically involve comparing the device's readings to established, highly accurate reference measurements.
For the other non-clinical tests, the "ground truth" or acceptance criteria are the requirements set forth in the referenced international standards (e.g., IEC, ISO, EN, ANSI/AAMI).
8. The Sample Size for the Training Set
The document describes pre-market notification for a medical device (patient monitor). This is typically a hardware and software system, not a machine learning algorithm that requires a "training set" in the conventional sense of AI/ML. Therefore, the concept of a "training set sample size" as commonly understood in AI/ML is not applicable here. The device's algorithms and underlying principles are likely based on established physiological measurement techniques, not on iterative learning from a large dataset.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" in the context of AI/ML is not applicable to this device's description. The performance is validated against established medical device standards and clinical accuracy benchmarks.
§ 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.