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The Infinity Medical Information Bus (MIB) Protocol Converters (MIB, 11 & MIB Duo) are indicated for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that third party medical devices that provide data should be connected to a Draeger Infinity Modular Monitor for display. Such devices include:

Maquet SV 300 ventilator
Maquet Servoi Ventilator
Maquet SV900 ventilator
Draeger Evita 2 ventilator
Draeger Evita 4 ventilator
Draeger EvitaXL ventilator
Draeger Savina ventilator
Draeger Babylog ventilator
Draeger FabiusGS Anesthesia System
Draeger Narkomed 2 Anesthesia System
Draeger Narkomed 4 Anesthesia System
Draeger Narkomed 6000 / 6400 Anesthesia Systems
Draeger Julian Anesthesia Machine
Puritan Bennett 7200 ventilator
Puritan Bennett 840 ventilator
Hamilton Galileo ventilator
Ohmeda 7900 Anesthesia Machine
Abbott Oximetrix 3 Blood Gas Analyzer
Abbott Q2 CCO monitor
AVL Medical Instruments: Opti Critical Care Analyzer, Portable Blood Gas Analyzer
Baxter Vigilance blood gas/continuous cardiac output monitor
Optical Sensors Inc .: OSI - Optical CAM
VIA Medical: VIA V-ABG1 Blood Gas Chemistry Monitor
Aspect A-2000 BIS Monitor*
Sensormedics Micro Gas 7650
Draeger Fabius Tiro
Draeger Primus
Viasys Bear 1000

Note: * The SC 9000 does not support communication with the Aspect BIS Monitor

Draeger's Infinity Medical Information Bus Protocol Converters have received numerous 510(k) clearances for connectivity to third party devices. The release of MIB VF5.1 software enables connectivity of the Viasys Bear 1000 ventilator to the Infinity modular monitors.

This connection enables the display of device specific data on an Infinity modular monitor. Data from the Viasys Bear 1000 ventilator can also be displayed and alarms annunciated on the VentCentral application (K003246) of the MultiView.

The provided text is a 510(k) Summary for a medical device (Draeger's Infinity Medical Information Bus Protocol Converter). This summary outlines device information, intended use, and substantial equivalence, but it does not contain details about acceptance criteria, device performance studies, or clinical trial data.

Specifically, the document states:

• "Assessment of non-clinical performance data for equivalence: Verification and validation testing performed indicates that the modifications implemented with software version VF5.1 are as safe and effective as previous versions and have not altered the fundamental technology of the device(s)." This indicates that some non-clinical testing was done to confirm the software update didn't change the core functionality or safety, but it doesn't provide specific criteria or results.
• "Assessment of clinical performance data for equivalence: Not applicable" This explicitly states that clinical performance data was not required for this 510(k) submission.

Therefore, I cannot fulfill your request for the following information based on the provided text, as it is not present:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, and for this particular device (a protocol converter for medical data display), extensive clinical performance studies or specific acceptance criteria for diagnostic accuracy (as would be seen in an AI/diagnostic imaging device) were deemed "not applicable."

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