(93 days)
The Unity Network ID is 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 text describes the Unity Network ID, a device designed for data collection and clinical information management. The information mainly focuses on its regulatory submission and general testing, rather than a specific study proving its performance against acceptance criteria in the context of an AI/human reader evaluation.
Therefore, many of the requested categories regarding acceptance criteria and a specific study cannot be fully answered from the provided document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance/Safety/Effectiveness | "The results of these measurements demonstrated that the Unity Network ID is as safe, as effective, and performs as well as the predicate devices." |
| Compliance with Voluntary Standards | "The Unity Network ID complies with the voluntary standards as detailed in Section 9 of this submission." |
| Quality Assurance Measures | - Risk Analysis |
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Final acceptance testing (Validation)
- Performance testing
- Safety testing
- Environmental testing |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly stated for a specific "test set" related to performance metrics. The document describes general "testing on unit level," "integration testing," and "final acceptance testing," but no details on sample size or data provenance for these tests are provided.
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. The device is a "physiological patient monitor" communication system, not one that requires expert interpretation for a "ground truth" like medical imaging or diagnostics. The validation seems to be against engineering and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is mentioned as there's no indication of interpretation by multiple experts.
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. This is not an AI-based device, nor is there any mention of a human-reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Partially. The device itself is "standalone" in its function as a data communication system. Its performance evaluation would be based on its ability to accurately acquire, convert, and transmit data, rather than an "algorithm only" performance in the context of diagnostics or interpretation. The document mentions unit-level, integration, and final acceptance testing, which imply standalone functional evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated in terms of a "ground truth" for diagnostic purposes. For this type of device, "ground truth" would likely refer to the correct functioning of data communication protocols and accurate data transfer, which would be measured against engineering specifications and validated data streams, rather than medical ground truth like pathology.
8. The sample size for the training set
- Not applicable. This device does not appear to use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. This device does not appear to use a "training set" in the context of machine learning.
§ 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).