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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, Inc. equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies Inc. 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.

Accessories include device specific interface cables and mounting hardware.

The provided document, a 510(k) Premarket Notification for the Unity Network ID v8, does not contain any information about acceptance criteria or a study proving that an AI/device meets specific performance metrics.

The device, Unity Network ID v8, is described as a data collection and clinical information management system that communicates patient data from various medical devices to a clinical information system. It is explicitly stated that this device is not intended for monitoring purposes, nor is it intended to control any clinical devices.

The document focuses on demonstrating substantial equivalence to a predicate device (Unity Network ID v7). This involves showing that the new version has similar technological characteristics and performance. The changes in v8 primarily involve software updates to support new third-party medical devices.

Therefore, many of the requested elements for describing acceptance criteria and a performance study (especially in the context of AI or advanced device performance) are not applicable to this submission.

Here's a breakdown of why this document doesn't provide the requested information, and what it does provide:

• No AI/Algorithm Component: This device is a data integration and communication system, not an artificial intelligence or an algorithm with diagnostic or prognostic capabilities that would require performance metrics like sensitivity, specificity, or reader studies.
• Focus on Substantial Equivalence: The entire submission is built around demonstrating that Unity Network ID v8 is substantially equivalent to its predecessor. This means focusing on hardware and software changes, and ensuring basic safety and functionality.

However, to address the prompt's structure based on the absence of the requested information:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: No specific numerical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) are stated because the device's function is data collection and management, not diagnostic interpretation. The acceptance criteria would likely revolve around successful data transfer, protocol compatibility, and absence of data loss or corruption.
• Reported Device Performance: No quantitative performance metrics are reported. The "performance data" section in the document refers to compliance with electrical safety, EMC, and software verification/validation standards.

Table:

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. This device does not use a "test set" of patient data in the sense of a machine learning model. Testing consists of software verification and validation (V&V) through bench tests, ensuring the software correctly performs its intended functions (receiving, converting, and transmitting data) and complies with design inputs. These are functional and non-functional tests of the software itself and its interfaces, not performance on a clinical dataset.

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. There is no "ground truth" in the clinical sense for this device. Its function is data transfer, not interpretation. Software verification does not involve expert clinical review of "ground truth."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No adjudication method is necessary as there's no clinical "ground truth" to establish or interpret.

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. This is not an AI-assisted diagnostic or interpretive device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an algorithm that produces a clinical output or diagnosis. Its "standalone" function is data integration and transfer, which is addressed through software and hardware verification.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. There is no "ground truth" as it pertains to clinical outcomes or diagnoses. The "truth" in testing relates to the correct functioning of the software and hardware according to specifications (e.g., "does data get transferred correctly?", "does the system comply with electrical safety standards?").

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or a "training set."

9. How the ground truth for the training set was established

• Not applicable. As there is no training set, this is not relevant.

In summary: The provided 510(k) submission for the Unity Network ID v8 describes a data communication and management device. It does not present performance data or studies typical for AI/ML-driven medical devices that output diagnostic or prognostic information. The "study" mentioned in the document refers to software verification and validation testing, and compliance with general medical device safety and quality standards, rather than clinical performance studies against a "ground truth."

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