(71 days)
The ESCORT Vision Central Station 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 Vision Central Station is a central station monitor comprised of a standard VGA display, a standard personal computer base and an auxiliary base or receiver hub used to mount the network communications hardware. The modified Stickman telemetry transmitter is an RF physiological signal transmitter comprised of an ECG measurement system packaged with a UHF transmitter.
The modified ESCORT Vision Central Station provides 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. The modified Stickman telemetry transmitter provides ECG signal monitoring and RF signal transmission.
The modified ESCORT Vision Central Station with Stickman Telemetry Transmitters communicates in the new WMTS band, providing protection against interference.
This document describes the ESCORT Vision Central Station with Stickman Telemetry Transmitter. The information provided primarily focuses on substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study specifically proving the device meets those criteria for clinical performance.
Here's a breakdown of the available information based on your requested categories:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table as typically seen for AI/ML device evaluations. The focus is on the device's technological characteristics being similar to the predicate and confirmation of testing for safety and accuracy of the ST algorithm.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| ST Algorithm Accuracy | "The ST algorithm has been tested for accuracy of the ST segment measurement data." (No specific metrics or quantitative results are provided in this summary.) |
| Safety Standards Compliance | "V&V testing and testing of the modified device to safety standards include the same ones as performed on the predicate devices with tests added to address issues raised as a result of the new hazard analysis." |
2. Sample size used for the test set and the data provenance
The document does not provide details on the sample size for any test sets or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the "ST algorithm has been tested for accuracy."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The document mentions that "The significance of the ST segment changes must be determined by a physician," but this refers to clinical interpretation, not the establishment of ground truth for a device's performance study.
4. Adjudication method for the test set
This information is not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
This information is not explicitly provided. The summary focuses on the device's technical characteristics and substantial equivalence, not a comparative effectiveness study involving human readers with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document indicates that "The ST algorithm has been tested for accuracy." This suggests a standalone evaluation of the algorithm's performance without a human in the loop, but no specific results or study design for this are detailed.
7. The type of ground truth used
The type of ground truth used for the ST algorithm accuracy testing is not specified. It's implied to be related to clinical ST segment changes, but whether this was expert consensus, pathology, or another method is not stated.
8. The sample size for the training set
This information is not provided. The document predates common AI/ML terminology like "training set."
9. How the ground truth for the training set was established
This information is not provided, as the concept of a "training set" and its ground truth establishment in the context of advanced machine learning is not discussed in this 2001 document. The device's modifications are primarily around communication hardware and software for channel/identifier programming, not a major AI algorithm update requiring extensive new training data.
§ 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.