(156 days)
The Biowatch Medical VST3 is indicated for use to monitor adults with abnormal heart rhythms and other symptoms of cardiac disease, such as:
- Arrhythmia or dysrhythmia .
- Skipped beats or pauses ●
- Rapid, slow, or irregular heart rate .
- Lightheadedness or faintness ●
- Palpitations .
The VST records and transmits ECG data to a remote central receiving station for interpretation by certified critical care specialists and/or a licensed over-read physician to identify cardiac rhythm disorders. The device is not intended to sound any alarms
The VST3 is an ambulatory ECG monitor. It is a wearable device capable of monitoring two channels of electrocardiogram. The device monitors each of the input channels and stores the information for later transmission via its cellular modem to a trained critical care specialist located at a remote clinical monitoring center. It provides real-time, continuous, interventional monitoring over extended periods of time. Additionally, upon receipt of appropriate commands, the device is capable of opening a cellular voice channel and/or transmitting its location information.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the VST3 Vital Signs Recorder and Transmitter as an ambulatory ECG monitor. However, it does not specify quantitative acceptance criteria or provide a study detailing the device’s performance against such criteria. The document is a 510(k) summary and clearance letter, primarily establishing substantial equivalence to predicate devices, not reporting on a detailed performance study with specific metrics.
Therefore, I cannot populate a table of acceptance criteria and reported device performance from this document.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific test set with a sample size or data provenance (country of origin, retrospective/prospective). The 510(k) process focuses on demonstrating substantial equivalence, which often relies on comparison to existing legally marketed devices rather than extensive de novo clinical trials for performance metrics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention a specific test set with established ground truth, nor does it specify the number or qualifications of experts involved in such a process. It states that ECG data is transmitted for "interpretation by certified critical care specialists and/or a licensed over-read physician," but this refers to the intended use of the device in clinical practice, not the establishment of ground truth for a performance study.
4. Adjudication Method for the Test Set
As no specific test set is described, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not indicate that an MRMC comparative effectiveness study was performed. The focus is on the device itself as an ambulatory ECG monitor, not on an AI-assisted interpretation system or the improvement of human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The VST3 is described as a "Vital Signs Recorder and Transmitter" that records and transmits ECG data for human interpretation. It does not appear to incorporate an internal algorithm for automated interpretation without human intervention. Therefore, a standalone algorithm performance study is not applicable to this device as described.
7. The Type of Ground Truth Used
The document does not describe any specific ground truth used for performance evaluation, as it doesn't detail such a study. The stated intended use involves interpretation by "certified critical care specialists and/or a licensed over-read physician," implying clinical interpretation as the ultimate reference for the data it collects.
8. The Sample Size for the Training Set
The document does not mention a training set size. As the device is described as an ECG recorder and transmitter rather than an AI-driven interpretive algorithm, the concept of a "training set" in the context of machine learning is not directly relevant to this description.
9. How the Ground Truth for the Training Set Was Established
Since no training set is discussed or implied for an AI algorithm (as this is an ECG recorder), this information is not applicable.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).