(64 days)
The indications for use for the Panorama Patient Monitoring Network include:
- Viewing real time patient clinical and demographic data
- Graphical and numeric trending of clinical data
- Storing and printing of clinical and demographic data
- Setting independent alarm limits for data sent by the bedside monitor
The clinical data displayed by the Panorama Patient Monitoring Network is obtained from one or more compatible physiological monitors and includes: ECG waveforms Invasive and Non-Invasive Blood Pressure, Blood Oxygenation (SpO2), Heart Rate, Respiration Rate, Respiration Gasses, Temperature, Carbon Dioxide, inspired and end tidal, Ventricular Arrhythmia analysis,ST Segment analysis, Arrhythmia Detection derived from 3/5 lead measurements, Cardiac Output, and Anesthetic Gas, and Pulse Rate.
The Panorama Patient Monitoring Network is intended for use in a fixed location, in the healthcare facility setting, as a central viewing station. The Panorama Patient Monitoring Network is not intended to be directly connected to the patient at any time or installed in a patient's vicinity.
The Panorama Network includes the Panorama Telemetry System which acquires and monitors physiological data for ambulating patients within a defined coverage area. The system processes the physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The Panorama Telemetry System is intended for installation in a hospital or clinical environment to provide clinicians with patient physiological data, while allowing for patient mobility.
The physiological parameters monitored include ECG, blood oxygenation (SpO2), Heart Rate, Lethal and Non-Lethal Arrhythmia Detection and ST Segment Analysis. Received data is sent to the Panorama Server for ECG processing via Ethernet. This information can be displayed, trended, stored and printed at the Panorama Central Station.
The Panorama Monitoring Network is intended for use under the direct supervision of a licensed healthcare practitioner.
The Panorama Patient Monitoring Network is a Central Station Monitor and Telemetry System. It is intended for use in a fixed location, in the healthcare facility setting, as a central viewing station. It receives clinical data from compatible physiological monitors and displays, trends, stores, and prints this data. It also allows for setting independent alarm limits. The system includes a Telemetry System for monitoring ambulating patients within a defined coverage area, processing physiological data to detect ECG arrhythmia events and parameter limit violations. The system consists of a Central Station, Telemetry Server, TIM Transceiver, Keyboard, Mouse, Display, and operates on Windows XPe (embedded). The Telemetry System includes a TIM Transceiver, operates on WMTS frequency, and uses a Radio Frequency Antenna and Telepack-608(WMTS) with an SpO2 Module.
The provided text describes the Mindray Panorama Patient Monitoring Network, a central monitoring system and telemetry system. However, the document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized safety and performance standards rather than presenting a performance study with detailed acceptance criteria and results for the device's diagnostic capabilities (e.g., arrhythmia detection accuracy).
Based on the provided information, I cannot provide a table of acceptance criteria and reported device performance for specific clinical diagnostic tasks, nor details about sample sizes, expert qualifications, or ground truth establishment for such tasks. The document explicitly states: "No clinical tests were performed on the Panorama Network."
Here's what can be extracted regarding performance testing and regulatory compliance:
1. A table of acceptance criteria and the reported device performance:
The document does not provide specific quantitative acceptance criteria or reported performance metrics (e.g., sensitivity, specificity, accuracy) for clinical diagnostic features like arrhythmia detection accuracy or ST segment analysis accuracy. Instead, it states compliance with general design and electrical safety standards and established parameter performance specifications.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Compliance with recognized safety standards | IEC60601-1, IEC60601-1-2, IEC60601-1-4, IEC60601-1-8 |
| Compliance with recognized performance standards | EC13, EC53, EC57, ISO 80601-2-61, ISO14970, ISO15223 |
| Compliance with established parameter performance specifications | Complies with established parameter performance specifications respecting ECG, Arrhythmia analysis, ST Segment analysis and SpO2. |
| Risk analysis and mitigation | Developed risk analysis to identify potential hazards and document mitigation. |
| Software verification and validation | Software has been verified and validated in accordance with appropriate test requirements. |
| Substantial equivalence | The Panorama Network is equivalent to the predicate device the ViewPoint Central Monitoring System respecting indications for use, basic operation, performance specifications, technology and materials. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document explicitly states, "No clinical tests were performed on the Panorama Network." Therefore, there is no information about a test set size or data provenance for clinical performance evaluation. The "tests" mentioned are related to engineering, safety, and performance standard compliance, not clinical data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. As no clinical tests were performed, no experts were used to establish ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical tests were performed.
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. The Panorama Network is a monitoring system and does not describe AI assistance for human readers in a diagnostic setting. Furthermore, no clinical tests were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device performs "Ventricular Arrhythmia analysis," "ST Segment analysis," and "Arrhythmia Detection derived from 3/5 lead measurements." The document states it "complies with established parameter performance specifications respecting ECG, Arrhythmia analysis, ST Segment analysis and SpO2." However, no specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) are provided for these algorithmic analyses. The compliance is broadly stated without quantitative results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Given the statement "No clinical tests were performed," there is no mention of ground truth derived from expert consensus, pathology, or outcomes data for the device's diagnostic performance. The "established parameter performance specifications" likely refer to internal engineering criteria and adherence to recognized standards for signal processing and parameter measurement.
8. The sample size for the training set:
Not applicable. This is a medical device submission based on substantial equivalence, and the document does not describe the development of an AI/ML algorithm that would typically involve a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set is mentioned in the context of this submission.
§ 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.