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The Medical Information Bus (MIB) Protocol Converters (MIB, II & 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 Siemens INFINITY Modular Bedside Monitor (SC 9000 / SC 8000 / SC 9000XL) for display. Such devices include: Siemens SV 300 ventilator Siemens Servoi ventilator Baxter Vigilance blood gas/CCO monitor Siemens SV900 ventilator Draeger Evita II ventilator Draeger Evita IV ventilator Draeger Babylog ventilator Puritan Bennett 7200 ventilator Puritan Bennett 840 ventilator Hamilton Galileo ventilator Draeger Narkomed II Anesthesia System Draeger Narkomed IV Anesthesia System Draeger Julian Anesthesia Machine 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 Optical Sensors Inc .: OSI - Optical CAM VIA Medical: VIA V-ABG1 Blood Gas Chemistry Monitor Aspect A-2000 BIS Monitor* Sensormedics Micro Gas 7650 Note: * The SC 9000 does not support communication with the Aspect BIS Monitor

Siemens Medical Information Bus (MIB) Protocol Converters have received numerous 510(k) clearances for connectivity to third party devices. The release of MIB VF2 software and MIB II VA2 software, along with device specific accessory cables enables MIB connectivity of the following devices to the INFINITY modular monitors (SC 9000/SC7000/SC9000XL/SC8000): Puritan Bennett 840 ventilator Hamilton Galileo ventilator Abbott Q2 Sensormedics Micro Gas 7650 These connections enable the display of device specific data on an INFINITY modular monitor. Data from the Puritan Bennett 840 and Hamilton Galileo ventilators can also be displayed on the VentCentral application (K003246) of the MultiView WorkStation. The modifications described have not altered the fundamental technology of the MIB/MIBII Protocol Converters.

The provided document describes a Special 510(k) submission for modifications to Siemens Medical Information Bus (MIB/MIBII) Protocol Converters. This type of submission focuses on demonstrating substantial equivalence to a predicate device, particularly when the modifications do not alter the fundamental technology or intended use.

Based on the information given, here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics in the format of a table. This is typical for a Special 510(k) for device modifications where the focus is on a qualitative assessment of whether the modifications altered the fundamental technology or intended use.

Instead, the submission states:

• "The modifications described have not altered the fundamental technology of the MIB/MIBII Protocol Converters."
• "The intended use and indications of the MIB with VF2 software and the MIBII with VA2 software, as described in its labeling, are the same as the intended uses and indications for the MIB/MIBII unmodified predicate devices."

The "reported device performance" is implicitly that the modified device performs equivalently to the legally marketed predicate devices (Siemens INFINITY MIB II Duo: K012461, Siemens INFINITY MIB II Protocol Converter: K010640, etc.) in terms of its function as a protocol converter for displaying third-party medical device data on Siemens modular monitors. The assessment relies on non-clinical performance data (Section J, which is not provided in detail) and the adherence to relevant standards.

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

The document does not specify a "test set" in the context of clinical data. It explicitly states:

• "Assessment of clinical performance data for equivalence: Not applicable"

This indicates that a clinical study with a predefined test set was not conducted as part of this particular submission. The assessment of equivalence was based on non-clinical data and adherence to standards.

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

As no clinical test set was used, there is no information provided regarding experts or ground truth establishment for a test set.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Since no clinical test set was used, there is no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This submission is for a medical information bus protocol converter, which is a device for displaying data from other medical devices. It is not an AI-enabled diagnostic or interpretive device, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

This refers to a protocol converter, not a standalone diagnostic algorithm. Therefore, a standalone performance study in the context of an algorithm's diagnostic accuracy was not performed or applicable. The "performance" of the device is its ability to correctly convert and display data, which is assessed through non-clinical means (likely functional testing and verification of data integrity).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Given that clinical performance data was not applicable, there is no mention of ground truth types like expert consensus, pathology, or outcomes data. The "ground truth" for this device would relate to the accuracy and integrity of the data transmission and display, which is verified through engineering and functional testing against the output of the connected third-party medical devices.

8. The Sample Size for the Training Set

This device is not an AI/ML algorithm that requires a training set. Therefore, there is no training set sample size provided.

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

As there is no training set, this information is not applicable.

In summary, for this particular Special 510(k) submission regarding a device modification:

The "study" proving the device meets acceptance criteria primarily consists of non-clinical performance data assessment (Section J) and demonstrated adherence to relevant standards (1073.3.1 and 1073.3.2). The core argument is that the modifications did not alter the fundamental technology or intended use compared to the legally marketed predicate devices. This approach is common for modifications that are considered minor and do not introduce new risks or change the fundamental operating principle. The FDA's issuance of the 510(k) clearance (K022766) indicates that they concurred with this assessment of substantial equivalence.

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