(64 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Unity Network ID device:
The provided text does not contain acceptance criteria presented as quantitative metrics or specific performance thresholds for the Unity Network ID. Instead, it describes general quality assurance measures and states a conclusion that the device performs as well as its predicate. Therefore, much of the requested information cannot be extracted directly from this document.
Here's what can be provided based on the input:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Quantitative) | Reported Device Performance | Comments |
|---|---|---|
| Not specified quantitatively | "as safe" | The document states the device performs "as safe, as effective, and performs as well as the predicate device." However, no specific performance metrics or acceptance thresholds are provided in this summary. |
| Not specified quantitatively | "as effective" | |
| Not specified quantitatively | "performs as well" |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not specified in the provided summary.
- Data provenance: Not specified in the provided summary (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. The document describes testing related to system verification and validation, but not expert-based ground truth establishment for clinical performance.
4. Adjudication method for the test set
- Not applicable/Not specified. The testing described (Risk Analysis, Requirements Reviews, Design Reviews, Subsystem Verification, Integration testing, Final acceptance testing, Performance testing, Safety testing, Environmental testing) does not indicate a need for a clinical adjudication method.
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. An MRMC comparative effectiveness study is not mentioned. The device, Unity Network ID, is a data communication system and not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The listed "Performance testing," "Safety testing," and "Environmental testing," along with "Subsystem Verification," "Integration testing (System verification)," and "Final acceptance testing (Validation)" would constitute standalone testing of the device's functionality and performance as a data communication system. The device itself does not involve a human in the loop for its core function of data transmission.
7. The type of ground truth used
- For the technical and performance testing of a data communication system like Unity Network ID, the "ground truth" would be established by:
- Functional Specifications/Requirements: The device is expected to correctly acquire, convert, and transmit data according to its design specifications.
- Industry Standards: Compliance with relevant voluntary standards (as mentioned in "Section 4.2 Specific Standards and Guidance").
- Predicate Device Performance: The underlying assumption and stated conclusion is that the device performs "as well as the predicate device," implying a comparative baseline for performance.
- Objective Measurements: Performance, safety, and environmental testing would rely on objective measurements against predefined criteria (though these criteria are not detailed in this summary).
8. The sample size for the training set
- Not applicable. The Unity Network ID describes a data communication hardware/software system, not a machine learning or AI algorithm that requires a training set in the typical sense.
9. How the ground truth for the training set was established
- Not applicable, as there is no mention of a training set for an AI/ML algorithm.
§ 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).