(126 days)
The ViewPoint Central Monitoring System is intended for use in a fixed location, in the health care facility setting, as a central viewing station. The ViewPoint Central Monitoring System is not intended to be directly connected to the patient at any time, or installed in a patient's vicinity.
The ViewPoint Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations.
The ViewPoint Telemetry System is intended for installation in the hospital or clinical environment to provide clinicians with patient physiological data, while allowing for patient mobility.
The ViewPoint Telemetry System is an expansion to the ViewPoint Central Monitoring System, previously cleared by FDA under K011540. There have been no significant changes to ViewPoint Central Monitoring System since its clearance. The standard configuration of the ViewPoint Central Monitoring System consists of the ViewPoint Central Station, network printers, displays, keyboard, speakers, universal power supply and a mouse.
The ViewPoint Telemetry System is an ambulatory monitoring system that is designed to be used in the hospital/clinical environment to acquire and transmit ECG data derived from wireless physiological monitor(s) via RF telemetry transmitter(s) and receiver(s). The ViewPoint Telemetry System consists of three components: the ViewPoint Server (Server), Access Point, and ViewPoint Telepack 2.4 (Telepack). The ViewPoint Telemetry System uses the capability of bi-directional communication with the Server, via an Access Point network installed throughout the specified coverage area. These Access Points interface with the Server through an Ethernet connection. The Server does not collect data directly from patients; rather, it receives data through the Access Point from monitors, such as a Telepack, performs ST/Arrhythmia analysis, and then forwards it to the ViewPoint Central Station.
The provided text describes the ViewPoint Telemetry System, a cardiac arrhythmia monitor. However, it does not explicitly detail specific acceptance criteria or a dedicated study with performance metrics that directly prove the device meets particular criteria. Instead, it outlines the device's intended use, its components, and its substantial equivalence to predicate devices, supported by a general statement about completed development activities and testing.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in what can be inferred and note when information is not available.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance | Comments |
|---|---|---|---|
| Safety | As safe as predicate devices | Deemed "as safe" | Based on overall development activities and testing. No specific quantitative safety metrics are provided. |
| Effectiveness | As effective as predicate devices | Deemed "as effective" | Based on overall development activities and testing. No specific quantitative effectiveness metrics (e.g., sensitivity, specificity for arrhythmia detection) are provided. |
| Performance | Performs as well as predicate devices | Deemed to "perform as well" | Based on overall development activities and testing. No specific quantitative performance metrics are provided. |
| Physiological Monitoring | Acquire and monitor ECG | Yes | Stated as a capability. |
| Monitor Heart Rate from ECG | Yes | Stated as a capability. | |
| Detect Lethal Arrhythmia | Yes | Stated as a capability. | |
| Detect Non-Lethal Arrhythmia | Yes | Stated as a capability. | |
| Perform ST Segment Analysis | Yes | Stated as a capability. | |
| Networking/Communication | Bi-directional communication with Server via Access Point | Yes | Stated as a capability. |
| Use 2.4 GHz ISM wireless band | Yes | Stated as a capability. | |
| Frequency hopping spread spectrum transmission | Yes | Stated as a capability. | |
| Ambulatory Use | Allow for patient mobility | Yes | Stated as a design feature and intended use. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document refers to "Performance testing" and "Hardware and Software validation" but does not provide details on sample sizes for any specific test sets.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The document does not describe the establishment of a ground truth for performance evaluation in a clinical study.
4. Adjudication method for the test set
- Not specified.
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, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device described appears to be a monitoring system that processes data, not an AI-assisted diagnostic tool for human readers in the context of image interpretation or similar tasks.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The device performs "ST/Arrhythmia analysis" and detects "various ECG arrhythmia events and select physiological parameter limit violations" autonomously. The document implies that this processing is done by the system, and then the information is displayed to clinicians. While not explicitly called a "standalone performance study," the system's ability to perform these analyses without direct human intervention suggests an inherent standalone algorithmic function. However, no specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) are provided for these algorithmic detections.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. Given the context of a 510(k) submission and substantial equivalence for a monitoring system, it's highly likely that engineering tests and comparisons to predicate device behavior were used. Clinical ground truth (e.g., confirmed arrhythmia diagnoses by cardiologists) for performance metrics is not detailed in this summary.
8. The sample size for the training set
- Not applicable. The document describes a medical device for monitoring, not an AI/ML algorithm that requires a distinct "training set" in the modern sense. The "development" process included "Hardware and software testing" and "Code design and code reviews," which would typically involve internal testing and validation against known standards and specifications, rather than machine learning training.
9. How the ground truth for the training set was established
- Not applicable, as there's no mention of a "training set" for an AI/ML algorithm.
§ 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.