(148 days)
Indicated for use in data collection and clinical information management through networks with independent bedside devices.
The Unity Network ID is not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices (independent bedside devices/ information systems) it is connected to.
The Unity Network ID system communicates patient data from sources other than GE Medical Systems Information Technologies equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies patient monitors.
The Unity Network ID acquires digital data from eight serial ports, converts the data to Unity Network protocols, and transmits the data over the monitoring network to a Unity Network device such as a patient monitor, clinical information system or central station.
The provided documentation does not contain information about acceptance criteria, device performance metrics, or a study that evaluates the device's diagnostic performance for medical insights in the way one would typically assess an AI/ML medical device.
The GE Medical Systems Information Technologies Unity Network ID (K021454) is a data communication and management system, not a diagnostic device that generates interpretations or analyses of patient data. Its purpose is to acquire digital data from various medical devices, convert it to a common protocol, and transmit it to other systems like patient monitors, clinical information systems, or central stations.
The "Test Summary" section describes quality assurance measures applied during development, such as risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, acceptance, performance, safety, environmental). However, these are developmental tests to ensure the system functions as designed and is safe and effective in its intended role as a data conduit, not to assess its ability to provide clinical insights or make diagnoses.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable to this device and are not present in the provided submission.
Based on the provided text, here’s a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functionality | Acquire digital data from 8 serial ports, convert to Unity Network protocols, transmit data over the network to a Unity Network device. | Device described as performing this function. No specific numerical performance metrics (e.g., data transfer speed, error rates) are provided beyond the general statement that "The Unity Network ID acquires digital data from eight serial ports, converts the data to Unity Network protocols, and transmits the data over the monitoring network." |
| Safety | Compliance with voluntary standards (as detailed in Section 9 of the submission, but not provided here). Risk analysis conducted. | Safety testing performed. Conclusion: "The results of these measurements demonstrated that the Unity Network ID is as safe... as the predicate device." |
| Effectiveness | Perform as well as the predicate device (Phillips Medical Systems, Inc., M2376A Device Link System – K012094) in terms of data collection and clinical information management. | Performance testing performed. Conclusion: "The results of these measurements demonstrated that the Unity Network ID is... as effective, and perform as well as the predicate device." |
| Connectivity/Protocol Conversion | Employ same functional scientific technology as predicate device for data acquisition and conversion. | "The Unity Network ID employs the same functional scientific technology as its predicate device." |
| Quality Assurance | Adherence to specified development processes (Risk Analysis, Requirements Reviews, Design Reviews, Unit testing, Integration testing, Final acceptance testing). | All listed quality assurance measures were applied. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The device is a data communication system. The testing described includes unit, integration, and final acceptance testing, as well as performance, safety, and environmental testing. These types of tests typically involve controlled lab environments and specific test cases designed to test system functionality, communication integrity, and adherence to power/environmental standards, rather than a "test set" of patient data in the context of diagnostic performance. There is no mention of patient data being used for device performance evaluation in this context.
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 / Not provided. Ground truth for diagnostic accuracy is not relevant for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided.
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 / Not provided. This device is not an AI/ML diagnostic tool; it's a data network interface.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. The device's function is purely data transmission and conversion; it does not provide an "algorithm only" diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided. The "truth" for this device relates to whether data is accurately acquired, converted, and transmitted without corruption, and whether it functions according to its specifications and regulatory standards. There is no diagnostic ground truth.
8. The sample size for the training set
- Not applicable / Not provided. This device is not an AI/ML model that would require a "training set" of data in that sense.
9. How the ground truth for the training set was established
- Not applicable / Not provided.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).