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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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The Datex-Ohmeda S/5 Device Interfacing Solution, DIS, is intended to be used with a Datex-Ohmeda monitoring systems for transferring data between external devices and a monitor.

The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01, 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.

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 and in $/5 Compact Anesthesia Monitor, $/5 Compact Critical Care Monitor, and S/5 FM monitor it 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. 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.

Acceptance Criteria and Study for Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01

The provided documentation describes a 510(k) premarket notification for the Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01, and focuses on demonstrating substantial equivalence to a legally marketed predicate device (N-DISxxxx..00). As such, the "acceptance criteria" and "study" are framed within the context of demonstrating this equivalence rather than establishing the performance of a novel device against predefined clinical metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

The documentation does not specify a "test set" sample size or data provenance in the way one might expect for a clinical performance study of an AI/ML device. The focus is on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical characteristics.

The "testing" mentioned is likely internal validation and verification activities against engineering specifications and recognized standards. No patient data (retrospective or prospective) is mentioned for a "test set" for the purpose of evaluating data transfer accuracy or clinical performance.

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

This section is not applicable as there is no mention of a "test set" requiring expert-established ground truth in the context of clinical performance for this device. The device's function is data transfer, not diagnostic or predictive, which typically requires expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

This section is not applicable as there is no mention of a "test set" and thus no adjudication method for establishing ground truth for such a set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human reader performance is being evaluated, often with or without AI assistance. The Datex-Ohmeda S/5 Device Interfacing Solution is a data transfer device and does not involve human interpretation of medical images or data in a way that an MRMC study would be relevant.

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

The device is a hardware and software system for data transfer. Its "performance" is inherently standalone in the sense that it automatically converts and transfers data. There is no "human-in-the-loop" for the primary function of data conversion and transfer; it's a device that facilitates the display and use of data by humans, but its core function is automated.

The "study" that proves the device meets its "acceptance criteria" (i.e., substantial equivalence) is the "summary of nonclinical testing for the device" which includes:

• Validation and verification of specifications: This refers to internal testing conducted by the manufacturer to ensure the device performs as designed.
• Assessment against recognized standards: The device was tested for compliance with specific electrical safety, electromagnetic compatibility (EMC), and labeling standards (e.g., EN 60601-1, IEC 60601-1-2).

These non-clinical tests serve as the "standalone" performance evaluation, demonstrating that the device functions correctly and safely in its intended environment.

7. The Type of Ground Truth Used

For the non-clinical testing and substantial equivalence claim, the "ground truth" would be:

• Engineering Specifications: The design and functional requirements of the device itself.
• Standard Requirements: The explicit requirements outlined in the referenced electrical safety, EMC, and labeling standards.
• Predicate Device Characteristics: The known, legally marketed characteristics and performance of the predicate device (N-DISxxxx..00), against which the new device (N-DISxxxx..01) is compared for equivalence.

8. The Sample Size for the Training Set

This section is not applicable. The Datex-Ohmeda S/5 Device Interfacing Solution is a data transfer device, not an AI/ML algorithm that requires a "training set" of data to learn or develop its capabilities. Its functionality is based on pre-programmed logic for converting data formats.

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

This section is not applicable as no training set is used for this device.

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The Datex-Ohmeda S/5 Device Interfacing Solution, DIS, is intended to be used with a Datex-Ohmeda monitoring systems for transfering data from external devices.

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

The Device Interfacing Solution (DIS) has the following key components: Device specific converter module, device specific cable, bus cable to another DIS converter module, if needed, and Datex-Ohmeda monitor bus cable.

External devices are connected to the monitoring system by using 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 S/5 Anesthesia Monitor, S/5 Critical Care Monitor, S/5 Compact Anesthesia Monitor, or S/5 Compact Critical Care Monitor.

The DIS converter module is connected to to the socket at the rear of the Datex-Ohmeda monitor with a bus cable. The bus cable is also used for connecting DIS converter modules to each other. Specific modules can be connected to the different type of external devices. Up to ten DIS converter modules can be connected in series. Each external device has its own specific DIS converter module that can be used only with that device. One DIS converter module is needed for interfacing one external device.

The use of a DIS system consists of making physical connections: connecting external devices to DIS and linking DIS modules together to make a complete bus, and sending the converted data to the S/5 monitoring system. The user can then select the source of measurement data for physiologic parameters displayed in the Datex-Ohmeda monitor.

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.

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.

The provided text describes a medical device, the "Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx," and its regulatory clearance process (510(k)). However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through empirical data (e.g., accuracy, sensitivity, specificity studies).

Instead, the document focuses on:

• Substantial Equivalence: The primary assertion is that the device is substantially equivalent to a predicate device (AS/3 Interface Board, B-INT (K935477)).
• Compliance with Standards: The study mentioned is a nonclinical one demonstrating compliance with various electrical safety, electromagnetic compatibility, mechanical, environmental tolerance, and software validation standards.
• Functional Description: Details about what the device does (e.g., converts data, interfaces with external devices) and what it does not do (e.g., perform physiological measurements itself, transfer alarms).

Therefore, I cannot populate the requested table or answer most of the questions directly from the provided text. The document is a regulatory submission demonstrating safety and effectiveness based on equivalence and adherence to general engineering and safety standards, not a performance study as typically understood in the context of diagnostic or AI-driven medical devices.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. The "study" refers to compliance testing against engineering standards, not a clinical or performance validation study with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic performance study involving expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The document describes "nonclinical testing" including "software validation and verification of specifications." This suggests some form of standalone testing was done for the software's functionality, but no specific performance metrics (like accuracy of data conversion, latency, error rates) are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the nonclinical testing, the "ground truth" would be the expected output or behavior of the device as defined by its specifications and the requirements of the standards (e.g., correct data format conversion, adherence to electrical safety limits). There's no biological or clinical "ground truth" in this context.

8. The sample size for the training set: Not applicable. This device does not use machine learning or AI that would involve a training set.

9. How the ground truth for the training set was established: Not applicable.

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