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The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01 with N-DISVENT..02, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heart-lung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is indicated for use by qualified medical personnel only.

S/5 Device Interfacing Solution (later referred to as DIS) is a module that transfers data between an external device and S/5 monitor. External devices are connected to the monitoring system by using small plug-in converter modules that handle the communication between the device and S/5 monitoring system. These DIS converter modules convert the data coming from the connected device to a format that can be utilized in the Datex-Ohmeda S/5 Anesthesia Monitor, Datex-Ohmeda S/5 Critical Care Monitor, Datex-Ohmeda S/5 Compact Anesthesia Monitor, Datex-Ohmeda S/5 Compact Critical Care Monitor, or Datex-Ohmeda S/5 FM. The use of a DIS system consists of making the physical connections connecting external devices to DIS and linking DIS modules together to make a complete bus. Then the DIS transfers data between a device and the S/5 monitoring system. The user can then select the source of measurement data for physiologic parameters displayed on the Datex-Ohmeda monitor. The first DIS converter module is connected to the socket at the Datex-Ohmeda S/5 monitor. In S/5 Anesthesia Monitor and S/5 Critical Care Monitor the DIS socket is located at the rear of the monitor in the F-CU8 monitor frame option and at the front of the monitor in the F-CU5(P) monitor frame option. In S/5 Compact Anesthesia Monitor, S/5 Compact Critical Care Monitor, and S/5 FM monitor the DIS socket is located in left hand side of the monitor. Additional DIS converter modules in a system are connected to each other with the bus cable. The external device is connected to the DIS converter module with a device specific cable. Up to ten DIS converter modules can be connected in the system. The maximum number of simultaneous interfaces is ten. The maximum length of interface cable is 10 meters (33ft). The number of DIS interfaces that can be used depend on the length of the interface cables and the particular monitor used. The Device Interfacing Solution supports interfacing of the following device categories: ventilators/anesthesia machines, stand-alone monitors, blood gas analyzers and heart-lung machines. The Device Interfacing Solution can interface numerical, waveform and event type of data from the external device. Alarms are not transferred but alarm status events are transferred. Interfaced data can be displayed on the monitor screen, trended, printed and used for record keeping purposes. Also, interfaced physiologic data is sent to the network to be viewed at the Central station monitor.

Since this is a submission for a medical device data converter (Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01 with N-DISVENT..02), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily focused on compliance with established medical device standards and verification/validation testing, rather than clinical performance metrics like sensitivity, specificity, or reader improvement typically seen with AI algorithms.

Therefore, many of the requested fields related to AI, ground truth, and expert evaluation are not directly applicable or reported in this type of submission. I will address the relevant sections based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

The document does not detail specific "test set" sample sizes in terms of patient data or case numbers. The testing described is primarily non-clinical verification and validation against technical standards for device functionality and safety. This involves testing the hardware and software functionality of the data converter itself.

• Sample Size (Test Set): Not applicable in the context of clinical "test cases." Verification and validation would involve a variety of interfaced devices and scenarios, but no specific numerical sample size for "test cases" is provided.
• Data Provenance: Not applicable in the context of patient data. The testing pertains to the operational performance of the device itself, not the analysis of patient-derived data by the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. "Ground truth" in this context refers to the correct functioning of the device according to its specifications and the standards it aims to meet. This is established by engineering and quality control experts during verification and validation, not by medical experts for clinical truth.

4. Adjudication Method for the Test Set

Not applicable. This concept is for resolving discrepancies in expert interpretation of clinical data, which is not the type of testing performed here. Adjudication in device testing would be internal to engineering and quality assurance processes for resolving test failures or anomalies.

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 device is a data converter, not an AI diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The device is inherently "standalone" in its function as a data converter; it performs its data transfer function independently. However, it's not an "algorithm-only" device in the AI sense. Its primary function is a passive one – converting and relaying data, not interpreting or processing it in a complex algorithmic way that would have standalone diagnostic performance metrics.

7. The Type of Ground Truth Used

The "ground truth" used for this type of device is:

• Engineering Specifications: The device must accurately transfer data as specified in its design documents.
• Compliance with Standards: The device must meet the requirements of the listed national and international safety, EMC, and labeling standards (e.g., IEC 60601-1, IEC 60601-1-2).
• Functional Verification: Data transferred from connected devices must match the source data precisely and accurately for parameters like patient demographics, ventilator alarm status events, and gas consumption events.

8. The Sample Size for the Training Set

Not applicable. This device does not employ machine learning or AI that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of medical device.

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