(163 days)
The ESCORT-LINK® Central Station Monitor is intended to be used to provide, using a wireless LAN for communication, centralized surveillance and documentation of patient vital sign data and arrhythmia/ST monitoring for a variable number of ESCORT® II Bedside Monitors and a variable number of UHF telemetry transmitters in the hospital environment. It is intended for use by healthcare practitioners trained in the use of the equipment only.
The ST algorithm has been tested for accuracy of the ST segment measurement data. The significance of the ST segment changes must be determined by a physician.
The modified ESCORT-LINK® Central Station Monitor Model 20500 is a Central Station Monitor comprised of a standard VGA display, a standard Personal Computer Base and an auxiliary base used to mount the network communications hardware.
The modified ESCORT-LINK® Central Station Monitor Model 20500 can provide centralized display, storage and recording (or printing) of patient vital sign and waveform data that are being monitored at ESCORT® II, 100, 300 or 400 Series Bedside Monitors or UHF Telemetry Receivers.
Data accumulated at ESCORT® II Bedside Monitors is sent via a proprietary Spread Spectrum Local Area Network to the modified ESCORT-LINK® Central Station Model 20500 for display and storage. Data accumulated from any of Medical Data Electronics' analog or digital telemetry transmitters is sent directly to the central station on standard UHF telemetry frequencies. Telemetry transmitter communication may include patient data similar to that described for the ESCORT® II Bedside Monitors. The modified ESCORT-LINK® Central Station Monitor Model 20500 oversees all communications activity, allowing each system component to pass information without interrupting patient monitoring.
The modified ESCORT-LINK® Central Station Monitor Model 20500 can provide alarm detection and reporting for all vital sign parameters available to the central station. This alarm response is in addition to alarms available at the ESCORT® II 100. 300 or 400 Series Bedside Monitors. Also, arrhythmia monitoring, with ST reporting, is available for up to 16 patients at the Central Station to provide the configurable ability to detect and report certain cardiac abnormalities, including ST abnormalities. Parameter alarms, arrhythmia alarms and ST alarms are independently configurable to accommodate the wide range of patients encountered in the hospital environment.
The Central Station provides storage of patient data. Stored patient data includes waveform and vital sign information. Stored waveform and vital sign data can be retrieved for viewing or printing.
The provided 510(k) summary for the ESCORT-LINK® Central Station Monitor Model 20500 with ST Option offers limited details regarding specific acceptance criteria and a comprehensive study to prove those criteria. However, I can extract the available information and structure it according to your request.
Here's an analysis of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria or a direct comparison to reported device performance in a table format. It generally mentions the device was "designed and tested to functional standards developed by independent and regulatory agencies."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| ST Measurement Accuracy | "The ST algorithm has been tested for accuracy of the ST segment measurement data." (No specific metrics provided) |
| Alarm Detection/Reporting | Demonstrated by "performance testing, stressing the areas of alarms detection and reporting." (No specific metrics provided) |
| Arrhythmia Detection/Alarms | Demonstrated by "performance testing, stressing the areas of ... arrhythmia detecting and alarms." (No specific metrics provided) |
| ST Event Detection/Alarms | Demonstrated by "performance testing, stressing the areas of ... ST event detecting and alarms." (No specific metrics provided) |
| Accuracy of Patient Vital Sign and Waveform Data | Demonstrated by "performance testing, stressing the areas of ... accuracy of patient vital sign and waveform data." (No specific metrics provided) |
| Safety and Effectiveness | Concluded to be "a safe, effective Central Station Monitor." (Qualitative conclusion) |
| Substantial Equivalence | Determined to be "substantially equivalent to the unmodified ESCORT-LINK® Central Station Monitor Model 20500." (Regulatory conclusion) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The document mentions validation against "the European ST-T (ESC) database." The size of this database for the specific testing performed is not provided.
- Data Provenance: "European ST-T (ESC) database." This indicates the data is from Europe. It is not specified whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not mentioned in the document.
4. Adjudication method for the test set
Not mentioned in the document.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done based on the provided text. The device is a central station monitor with an ST option, not an AI interpretation tool for human readers. Its primary function is to provide automated ST analysis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, implied. The algorithm comprising the modification (the ST analysis) was "validated against the European ST-T (ESC) database," suggesting a standalone performance evaluation of the algorithm. The device itself operates "without human-in-the-loop performance" for the ST analysis function. The physician's role is to interpret the significance of the changes detected by the device.
7. The type of ground truth used
The ground truth for the ST analysis algorithm's validation was established from "the European ST-T (ESC) database." This database is typically a collection of annotated ECG recordings where ST-T changes (and often associated clinical events like ischemia) are validated, often by expert cardiologists or based on clinical outcomes. However, the specific method of ground truth establishment within that database (e.g., expert consensus, angiography results, pathology) is not detailed in this 510(k) summary.
8. The sample size for the training set
Not mentioned in the document. The document only refers to validation data.
9. How the ground truth for the training set was established
Not mentioned in the document, as no information on a training set is provided.
§ 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.