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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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The Infinity 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 Draeger INFENTTY 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-ABGI Blood Gas Chemistry Monitor Aspect A-2000 BIS Monitor* Sensormedics Micro Gas 7650

Note: * The SC 9000 does nor support communication with the Aspect BIS Monitor

Draeger's Infinity Medical Information Bus (MIB/MIBII and MIB Duo) Protocol Converters have received numerous 510(k) clearances for connectivity to third party devices. The release of MIB/MIBII VF4 software enables MIB connectivity of the following Draeger devices to the INFINITY modular monitors:

Narkomed 6000 & 6400 Fabius GS Savina Evita XL

These connections enable the display of device specific data on an INFINITY modular monitor. Data from the devices can also be displayed on the VentCentral application (K003246) of the MultiView WorkStation and alarms received from the Evita XL and Savina ventilators annunciated.

This submission, K033807, describes a modification to the Draeger Medical Information Bus (MIB/MIBII and MIB Duo) Protocol Converters. The primary change is the enablement of MIB connectivity for new Draeger devices (Narkomed 6000 & 6400, Fabius GS, Savina, Evita XL) to the INFINITY modular monitors through VF4 software. The key takeaway from the document is that no new clinical or non-clinical performance data was deemed necessary to establish substantial equivalence for this modification.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, and expert adjudication and ground truth establishment is not applicable to this specific 510(k) submission, as it relies on the predicate device's established performance without introducing new performance claims that would require new and extensive testing.

Here's a breakdown of the applicable information based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Since this is a modification to an already cleared device and the submission states "Assessment of non-clinical performance data for equivalence: Section J" and "Assessment of clinical performance data for equivalence: Not applicable," specific acceptance criteria and detailed reported performance for the modified aspects are not explicitly defined in this document. The implicit acceptance criterion is that the modified device maintains the fundamental technology, intended use, and safety/effectiveness of the predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample size for test set: Not applicable (no new testing for this modification was deemed necessary beyond demonstrating functionality of the new connections).
• Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Number of experts: Not applicable.
• Qualifications of experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Adjudication method: 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:

• MRMC study: Not applicable. The device is a protocol converter, not an AI-driven diagnostic system.

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

• Standalone performance study: Not applicable. The device is a hardware/software protocol converter for data display, not an algorithm with standalone performance metrics in the typical sense.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Type of ground truth: Not applicable for new testing specific to this modification. The "ground truth" for the predicate device would have been the accurate transmission and display of physiological data, which, for a protocol converter, relies on functional verification rather than clinical outcomes or expert consensus in the same way a diagnostic imaging device would.

8. The sample size for the training set:

• Sample size for training set: Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

• Ground truth establishment: Not applicable.

In summary, this 510(k) submission is for a device modification that extends connectivity, and it leverages the substantial equivalence of its predicate devices without requiring new, extensive performance studies for clearance.

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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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The Siemens Medical Information Bus (MIB/MIB II and MIB Duo) Protocol Converters are intended for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that a third party medical device that provides data, such as: Siemens SV 300 ventilator, Siemens Servoi Ventilator, Baxter Vigilance blood gas/continuous cardiac output monitor, Siemens SV900 ventilator, Draeger Evita II ventilator, Draeger Evita IV ventilator, Draeger Babylog ventilator, Puritan Bennett 7200 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, 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 should be connected to a Siemens INFINITY Modular Monitor for display.

The Medical Information Bus (MIB) Protocol Converters have received six 510(k) clearances for connectivity with third party devices. Minor software modifications have been implemented in the MIB/MIB II and MIB Duo protocol converters, and a device specific accessory cable is now available that allows an interface connection for Siemens Servoi Ventilator (K010925) to the INFINITY modular moritors (SC 9000/SC7000/SC9000XL/SC8000). This connection enables the display of Servoi Ventilator data on an INFINITY modular monitor and on the VentCentral display (K003246) of the MultiView WorkStation.

This document is a 510(k) summary for the Siemens Medical Information Bus (MIB, MIB II, MIB Duo) Protocol Converter. It outlines the device's purpose, previous clearances, and intended use. The content focuses on regulatory compliance and equivalence to predicate devices, rather than a detailed study demonstrating performance against specific medical acceptance criteria.

Therefore, many of the requested fields cannot be directly extracted or inferred from this document.

Here's an assessment based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or detailed device performance metrics in the way a clinical study would for diagnostic accuracy or treatment efficacy. The assessment for equivalence is based on "non-clinical performance data" without explicit criteria or results mentioned.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document is a regulatory submission for a protocol converter, not a clinical study involving patient data or a test set in the traditional sense for evaluating diagnostic or therapeutic efficacy. The "non-clinical performance data for equivalence" refers to technical characteristics and functionality.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment by medical experts is described, as this is a device for data integration, not for making clinical diagnoses or treatment decisions itself.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is described.

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 protocol converter, not an AI-assisted diagnostic or therapeutic tool. No MRMC study or AI-related performance improvements are mentioned.

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

Not applicable. This device is not an algorithm for standalone performance. Its function is to facilitate data display for human healthcare professionals.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant to this device's function as a protocol converter.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

Not applicable. There is no training set mentioned.

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