Search Results

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 (Lethal and Non-Lethal Arrhythmia Detection, ST Segment Analysis, QT Analysis and heart rate(HR)), Invasive Blood Pressure (IBP), Non-Invasive Blood Pressure(NIBP), Blood Oxygenation (SpO2), Pulse Rate (PR), Respiration Rate (RESP), Respiration Gases(O2, CO2), Temperature(TEMP), Anesthetic Gases (AG), Cardiac Output(C.O.), Bispectral Index (BIS), and Hemodynamics.

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 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 through telemetry include ECG (Lethal and Non-Lethal Arrhythmia Detection, ST Segment Analysis, OT Analysis and heart rate(HR)), blood oxygenation (SpO2), Pulse Rate (PR), Received data is calculated at the Panorama Central Station, and can be displayed, trended, stored and printed at the Panorama Central Station.

The Panorama Patient Monitoring Network is intended for use under the direct supervision of a licensed healthcare practitioner.

The subject Panorama Patient Monitoring Network includes eight Components:

• o Panorama Central Station
• Panorama Telemetry System
• Panorama Telepack ●
• Compatible Physiological Monitor(s) ●
• o ViewStation
• WorkStation ●
• Web Viewer ●
• Gateway ●
• 1、The Panorama Central Station is a device that monitors patients, collects and stores data.and performs alarm notification .The clinical data displayed at the Central Station is derived from compatible physiological monitor(s) or the Panorama Telepack.
• 2、The Panorama Telemetry System is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area.
• 3、The Panorama Telepack is a battery powered ambulatory monitoring device intended for use in a hospital/clinical environment to provide clinicians with patient physiological data, while allowing for patient mobility. Data received from the Telepack is transmitted to the Panorama Telemetry System .
• 4、Mindray's cleared Compatible Physiological Monitors that transmit patient data to the Central Station include:
  • · Passport 12M/17M Monitor(K143195)
  • · Passport 8/12 Monitor(K132662)
  • · T1(K143195)
  • · Passport V Monitor(K091834)
  • · V Series Monitor(K132026)
  • · DPM 6/7 Monitor(K092449)
  • · Spectrum/ Spectrum OR Bedside Monitor(K062098)
  • · Passport 2 Bedside Monitor (K020550)
• 5、The Panorama ViewStation is a software application that allows the user to remotely display and print patient information from the Central Station.
• 6、The Panorama WorkStation is a software application that allows the user to remotely display and print patient information, enter or change patient demographic information, change alarm limits and responses, place patients in standby or discharge patients.
• 7、The Panorama Web Viewer is a software application that provides the user to remotely view patient information from the Central Station through a facilities intranet using a Microsoft Internet Explorer web browser.
• 8、The Panorama Gateway is an embedded Windows XP software application that allows translation of the Mindray proprietary network format into standard formats such as HL7.

Here's an analysis of the provided text regarding acceptance criteria and device performance:

Unfortunately, the provided text does not contain explicit details about specific acceptance criteria or a dedicated study proving performance against those criteria for the Panorama Patient Monitoring Network itself.

The document is a 510(k) summary for a medical device (Panorama Patient Monitoring Network). The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove safety and effectiveness through clinical trials in the same way a PMA (Pre-Market Approval) does.

The closest statements related to testing are:

• "The Panorama Network has been tested and complies with the following recognized consensus standards: ANSI/AAMI ES60601-1, IEC60601-1-2, IEC60601-1-6, IEC60601-1-8, IEC60601-2-27, EC57, ISO80601-2-61"
• "The Panorama Network was tested and complies with established parameter performance specifications."
• "No clinical tests were performed on the Panorama Network. The clinical safety and effectiveness of the central monitoring networks has been long established through analysis of end-user experience and feedback gained through post-market analysis."
• "The device's software has been verified and validated in accordance with the appropriate test requirements."

These statements indicate various types of testing (safety, performance to established specifications, software verification/validation) but do not present a structured study with defined acceptance criteria and reported device performance for specific clinical claims (e.g., accuracy of arrhythmia detection).

Therefore, I cannot populate the table and answer most of the questions as requested. However, I can infer some general information from the document:

Inferred Information from the Document:

While explicit acceptance criteria and a dedicated performance study are not detailed, the text states the device was tested and "complies with established parameter performance specifications." This implies that the device does have internal performance specifications which it met through testing, even if those specifications and the test results are not explicitly provided in this public summary.

The document emphasizes substantial equivalence to predicate devices, particularly regarding indications for use and technological characteristics. The addition of QT Analysis and Bispectral Index (BIS) monitoring seems to be the main technological expansion compared to the primary predicate, and performance for these would likely be shown by demonstrating equivalence to the specified predicate devices (Philips ST/AR ST and Arrhythmia software and Hypervisor central monitoring system, respectively).

Table of Acceptance Criteria and Reported Device Performance:

Answers to Specific Questions:

1. A table of acceptance criteria and the reported device performance:

   • See the table above. Most information is "Not specified" or "Implied" because the document focuses on substantial equivalence rather than explicit performance metrics for clinical claims.

2. Sample size used for the test set and the data provenance:

   • Not specified. The document states "No clinical tests were performed on the Panorama Network." The performance is established through "analysis of end-user experience and feedback gained through post-market analysis" of predicate devices, and through technical standards compliance for the current device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable / Not specified. Given that no clinical tests were performed and the device relies on substantial equivalence and compliance with technical standards, there is no mention of experts establishing ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable / None specified. No clinical test set requiring adjudication is mentioned.

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. This device is a monitoring system and does not involve AI assistance for human readers in a diagnostic interpretation context. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, implicitly. The compliance with "established parameter performance specifications" and recognized standards (e.g., for arrhythmia detection) implies that the algorithms responsible for these functions were tested without human intervention to ensure they meet their design requirements. However, specific separate "standalone studies" with detailed metrics are not described in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Primarily
     technical specifications and standards. For parameters like arrhythmia detection, the "ground truth" would come from reference ECG waveforms or simulated data with known events, against which the device's algorithms are benchmarked according to industry standards like IEC60601-2-27 and EC57. For new parameters like QT Analysis and BIS, the ground truth would be implicitly derived from the established performance of the named predicate devices.

8. The sample size for the training set:

   • Not specified. This document does not discuss machine learning models, so there is no mention of training sets. The device's functionality is based on established algorithms and hardware.

9. How the ground truth for the training set was established:

   • Not applicable. No training set is mentioned as the device does not appear to utilize machine learning in the conventional sense that would require a separate training dataset with established ground truth.

Ask a specific question about this device

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.

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.

Ask a specific question about this device