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The Connex® Workstation is intended to be used by clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities.

In addition to the central monitoring of patient data and alarms, the Connex software can include optional modules to provide extended recording of patient data, including full disclosure.

Connex Workstation is a Windows-based product that provides clinicians with a means to remotely monitor the health of several patients simultaneously. The workstation receives patient vital signs and alarm data from patient monitors over a network, then displays the data and sounds audio alarms, acting as a secondary alarm system.

Specific patient populations are determined by the requirements of the devices gathering the patient data.

In the Connex Workstation, there are two possible sources of patient data, namely:

• a. Continuous monitoring devices that are attached to the patient, or
• b. Episodic measurements taken from devices that may or may not be constantly connected to the patient.
  Devices providing the patient data may transfer the data electronically to the hospital network for communication with the Connex Workstation via methods such as USB, wired Ethernet, or wireless communications. The Connex Workstation is wired to the network via Ethernet.

The Connex CS system can be deployed as either a standalone central station or as a server-based deployment where one or more central stations are connected to a Connex server.

Additionally, a kiosk option may be installed on personal computers (PCs) that are running Windows 7, 64 bit, which allows the user to upload episodic data through a USB port to the Server, via the network.

The Welch Allyn Connex® Workstation is a central monitoring system for patient vital signs and alarms. It is not an AI/ML device and therefore does not have acceptance criteria or studies related to AI/ML device performance.

The 510(k) summary explicitly states:
"No clinical studies were utilized for the purpose of obtaining safety or effectiveness data."

Instead, the submission relies on:

• Substantial Equivalence: The device is considered substantially equivalent to a predicate device (Acuity Central Station, Model 020XXXXX, K052160) because it has similar technological characteristics and indications for use.
• Non-Clinical Tests: Verification and validation were conducted to ensure expected performance based on relevant medical device and software safety standards (e.g., IEC 60601 series, IEC 60950, IEC 62304, ISO 14971).

Since this is not an AI/ML device, the following points are not applicable as they pertain to AI/ML performance evaluation:

• Table of acceptance criteria and reported device performance (for AI/ML metrics).
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study.
• Standalone AI performance.
• Type of ground truth used for AI/ML.
• Sample size for the training set.
• How ground truth for the training set was established.

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