(204 days)
The Dyna-Vision Telemontoring System is a wreless monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings and for normal daily activities. Physiological data recorded include: Electrocardiography (EGG), Heart Rate variability (R-R interval), Peripheral capillary Oxygen saturation (SpO2), Skin Temperature and respiration effort Data is transmitted wirelessly in near real time to a central location where it is stored for analysis. The Dyna-Vision™ system can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters. Data from the Dyna-Vision™ system is intended to be used by healthcare professionals as an aid to diagnosis and treatment.
The device is intended for use on general care patients aged 18 years or more, as a general patient monitor, to provide physiological information. It is not intended for use on critical care patients.
The Dyna-Vision system is a wireless multi-parameter data collection systems that monitors physiological data such as: Electrocardiography (EGG), Heart Rate, Heart Rate variability (R-R interval), Peripheral capillary Oxygen saturation (SpO2), Skin Temperature and Rate of respiratory effort.
The system consist of:
• A body-worn unit with sensor input modules for the near real time acquisition of the physiological data with built-in wireless communication for data transmission.
• A telemetry server to receive the physiological data and transmit the physiological data to
• A workstation installed on a central server (or PC) equipped with software with which the physician can process the physiological data and create reports regarding the transmitted data, and read and configure alerts/notifications when a threshold value is exceeded. The alert function is an adjunct to and not intended to replace vital sign monitoring.
The software includes algorithms for Heart Rate, Heart Rate variability (R-R interval) and rate of respiratory effort.
The device is intended to be used by clinicians and medically qualified personnel in healthcare facilities. The body-worn unit for data acquisition, is a transportable battery-operated unit to record Electrocardiograph (ECG), Heart Rate variability (R-R interval), Peripheral capillary Oxygen saturation (SpO2), Skin Temperature and Rate of respiratory effort to be also used by the patient in the home setting and anywhere where WIFI or cell communication is available.
The Dyna-Vision system works with 3rd party 510(k) cleared SpO2 module (Nonin OEM III, K092101), and ECG patient lead (Scottcare K092947).
The device is intended for use on general care patients aged 18 years or more.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dyna-Vision Telemonitoring System:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a quantitative table format with corresponding performance metrics like a typical validation study report. Instead, the "Substantial Equivalence Comparison Table" (Pages 7-10) compares the Dyna-Vision system's features and specifications against multiple predicate devices. The "acceptance criteria" are implied by the features and performance characteristics of the predicate devices. The non-clinical tests section (Page 5) lists the characteristics tested.
Based on the provided information, I can infer the "acceptance criteria" through the comparison with predicate devices and the performance "reported" by the Dyna-Vision system's specifications.
| Feature / Acceptance Criteria (Inferred from Predicate Performance & Device Specifications) | Reported Dyna-Vision Performance |
|---|---|
| ECG Monitoring | |
| Method | ECG lead wires attached to disposable electrodes to the skin |
| Resolution | 24 bit |
| Input Impedance | > 20 Mohm |
| Common Mode Rejection | -80dB - 100dB |
| Sampling Frequency | 1,000, 800, 400 and 200 Hz |
| Channels | 3, 5 and 12 channels |
| QRS Detection / AF Detection Accuracy | Yes - 99.8% |
| Heart Rate Monitoring | |
| Method | QRS detection |
| Range | 25-300 bpm |
| Accuracy | ± 2 bpm |
| Respiration Monitoring | |
| Method | Impedancy Pneumography |
| Impedance dynamic range | >20 ohms |
| Resolution | 5 seconds |
| Range | 2 - 150 breaths/min |
| Skin Temperature Monitoring | |
| Method | Skin thermistor |
| Range | 0° to +50°C |
| Accuracy | >10°C to +50°C: ±0.1°C; >50° to +122°F: ±0.2°F |
| Oxygen Saturation (SpO2) Monitoring | |
| Method | Photoplethysmogram on finger |
| Infrared | 910 nanometers @ 1.2 mW maximum average |
| Red | 660 nanometers @ 0.8 mW maximum average |
| Range | 0-100% |
| Accuracy | ± 2 digits (from 70-100%) |
| Alert/Notification Functionality | System can be configured to notify healthcare professionals when physiological data falls outside selected parameters. |
| Communication, Data Transmission & Storage | Wireless (Wi-Fi, Cellular), USB, 4 GB SD card memory, 60 days recording period. Central monitoring & data sent to central server. |
| Reliability (QoS) Wireless Quality of Service | Bench testing completed |
| Electromagnetic compatibility (EMC) | Meets IEC 60601-1-2 requirements |
| Electrical safety testing | Meets IEC 60601-1 requirements |
| Wireless Coexistence Wi-Fi testing | Bench testing completed |
| Software verification and validation testing | Bench testing completed |
| Biocompatibility verification | Bench testing completed |
| Usability testing | Usability validation is part of the Clinical Performance data |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical studies were utilized for the purpose of obtaining safety and Clinical Performance effectiveness data." This indicates that no patient-based "test set" in the traditional sense was used for clinical performance evaluation. The evaluation was based on non-clinical (bench) testing and substantial equivalence to predicate devices. Therefore, sample size and data provenance (country of origin, retrospective/prospective) for a test set of patient data are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical studies or patient-based test sets were used, there were no experts establishing ground truth for such a set. The "ground truth" for the non-clinical tests would have been established by the standards and methodologies used in the bench testing.
4. Adjudication Method for the Test Set
As no clinical test set was used, no adjudication method was employed.
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
The document does not mention any MRMC comparative effectiveness study. The device is a "Telemonitoring System," not an AI diagnostic tool designed to assist human readers in interpreting medical images or complex data in an MRMC study context. Its purpose is continuous collection of physiological data and alerting based on parameters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document details extensive standalone (algorithm only/device only) performance testing through "Bench testing" and adherence to "Referenced Standards and Performance Testing." This includes:
- Electrocardiograph (ECG)
- Heart rate variability (R-R interval)
- Heart rate
- SpO2
- Skin Temperature
- ECG impedance for Rate of respiratory effort
- Notification (alert function)
- Measurement accuracy
- Communication, data transmission and storage
- Reliability (QoS) Wireless Quality of Service
- Electromagnetic compatibility (EMC)
- Electrical safety testing
- Wireless Coexistence Wi-Fi testing
- Software verification and validation testing
- Biocompatibility verification
The device's algorithms for Heart Rate, Heart Rate variability (R-R interval), and rate of respiratory effort were also implicitly tested in this standalone context against the performance claims.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical bench testing, the ground truth would have been established by:
- Reference measurement equipment/systems: Calibrated medical devices or simulators that provide known, accurate physiological signals for comparison.
- Established engineering and medical standards: The device was tested against standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-47, AAMI/ANSI EC38, AAMI/ANSI EC57, ISO 80601-2-61, and IEC 80601-2-59. These standards define the acceptable performance limits and test methodologies for medical electrical equipment, including physiological monitors.
8. The sample size for the training set
The document explicitly states "No clinical studies were utilized for the purpose of obtaining safety and Clinical Performance effectiveness data." This implies that patient data was likely not used for training any machine learning or AI models in a traditional sense. The device appears to rely on established signal processing algorithms for its physiological measurements rather than complex, data-trained AI. Therefore, a "training set" in the context of machine learning is not discussed or implied.
9. How the ground truth for the training set was established
Since no clinical training set is mentioned or implied, the question of how its ground truth was established is not applicable. The algorithms for Heart Rate, Heart Rate variability, and respiratory effort are likely based on well-understood physiological principles and signal processing techniques, rather than being "trained" on a large dataset with annotated ground truth.
§ 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.