Search Results

The Infinity Gateway software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

The Infinity Gateway Suite is a suite of software applications that are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

Infinity Gateway Suite is designed to support the unique needs of hospitals, and provide a complete range of options for information connectivity, including:

• Server Software Health Level seven (HL7) Interface Software Options -
• -American society for testing and materials (ASTM) Stat Lab interface
• -Developer Tools
• Pager Interface -
• -Alarm history database
• -Time master functions
• -12-lead electrocardiogram (ECG) export

Infinity Gateway Suite is designed as a client-server application that provides a way for users to view patient information on a hospital workstation that is connected via the hospital network. The server portion runs on a Windows server that is connected directly to the hospital Local Area Network (LAN) and to the Infinity Network. Data access methods are available as options that customers can purchase and enable independently once they install the basic Infinity Gateway application.

The Infinity Gateway Suite facilitates the exchange of important clinical information between the Infinity protocol and existing hospital and patient care systems. The Infinity Gateway Suite is designed to provide flexibility by using common healthcare protocols and data format standards for managing communications between multiple disparate systems. The user may select one or more Infinity Gateway Developer Tools and/or Interface Options to create a seamless flow of information tailored to support clinical workflow.

Infinity Gateway Developer Tools and Interface Options are licensed or unlocked by using option passwords associated with a dongle. An option password is the electronic proof of purchase for the Infinity Gateway software. During the at-hospital setup procedure, the user will be asked for an option or license password which is a unique number associated with the licensing dongle issued. The licenses are always associated with the physical dongle. The Infinity Gateway Developer Tools (such as WinAccess API) enable the development of custom applications to support customers' homegrown applications to support clinical research projects or downstream information systems. Finally, Infinity Gateway provides flexible deployment opportunities by leveraging the virtual machine technology, which facilitates software deployments.

Infinity Gateway also promotes patient safety with efficient workflows for timely decisionmaking by integrating patient data and providing continuity-of-care support. Furthermore, it makes comprehensive clinical data available at the point-of-care by facilitating the exchange of lab reports and admission information between the Infinity Network and other hospital systems.

The subject device is compatible with Infinity Central Station Wide version VG5.0

This document is a 510(k) Premarket Notification from the FDA granting clearance for the Infinity Gateway Suite (VF9.1.1) from Draeger Medical Systems, Inc. It primarily addresses cybersecurity updates and other software improvements to an existing device.

Based on the provided text, the device is software only and does not involve AI/ML capabilities or diagnostic imaging. Therefore, most of the requested information regarding acceptance criteria, study methodologies (like multi-reader multi-case studies, standalone performance), ground truth establishment, expert adjudication, and sample sizes for training/test sets is not applicable in the context of typical AI/ML medical device submissions.

Here's a breakdown of the relevant information from the document as it pertains to the device's performance given its nature:

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

Since this is a software update primarily focused on cybersecurity and feature removal/modernization, traditional performance metrics like sensitivity, specificity, or accuracy (as seen in diagnostic AI devices) are not presented. The acceptance criteria relate to the successful implementation of the software updates and ensuring the device still functions as intended.

• ANSI AAMI ISO 14971:2019 (Risk Management)
• ANSI AAMI IEC 62304:2015 (Software Life Cycle Processes)
• ANSI AAMI IEC 62366-1:2020 (Usability Engineering) |

2. Sample sizes used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated in terms of patient data or specific number of test cases, but the document mentions "All test cases were determined to meet their respective requirements," implying a set of defined test cases were executed.
• Data Provenance: Not applicable in the context of patient data as this is a software update for network communication and data exchange, not a device that processes or analyzes patient-derived data for diagnostic purposes. The testing is functional and performance testing of the software itself. The document does not specify country of origin for testing, nor whether it was retrospective or prospective, as these are not relevant to this type of software update.

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):

• This is not applicable. Ground truth, in the sense of clinical annotations by experts, is not established for this type of software. The "ground truth" here is the expected behavior and functional requirements of the software, verified through standard software V&V processes.

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

• This is not applicable. Adjudication is typically used for ambiguous cases in clinical data annotation (e.g., differentiating between expert opinions on an image). For software functional testing, results are typically binary (pass/fail) based on predefined requirements.

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:

• This is not applicable. The Infinity Gateway Suite is a data exchange and remote viewing software, not an AI/ML diagnostic or assistive device that would be used by human "readers" (e.g., radiologists, pathologists) to interpret medical images or data. Therefore, an MRMC study is irrelevant to this device.

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

• The device is a "standalone" algorithm in a sense that it performs its functions (data exchange, remote viewing) automatically. However, "standalone performance" usually refers to the diagnostic accuracy of an AI model on its own. Since this device doesn't perform diagnoses or predictions, this concept isn't directly relevant in the typical sense for AI. Its performance is about its functionality and interoperability.

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

• This is not applicable in the clinical sense. The "ground truth" for this software is its documented functional and cybersecurity requirements, against which the software's performance is verified.

8. The sample size for the training set:

• This is not applicable. The Infinity Gateway Suite is described as a software suite with specific functionalities (HL7 interface, Pager interface, data exchange, etc.) and cybersecurity updates. It is not an AI/ML model that undergoes a "training" phase with a dataset.

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

• This is not applicable for the same reason as point 8.

Ask a specific question about this device

The Infinity Gateway software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

The Infinity Gateway Suite is a suite of software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

Infinity Gateway Suite is designed to support the unique needs of hospitals, and provide a complete range of options for information connectivity, including:

• Server Software Health Level seven (HL7) Interface Software Options -
• -American society for testing and materials (ASTM) Stat Lab interface
• -Developer's Tools
• -Remote View Applications
• । Pager Interface
• -Alarm history database
• -Time master functions
• -12-lead electrocardiogram (ECG) export
• Service-Oriented Device Compatibility (SDC) interface with encryption -

Infinity Gateway is designed as a client-server application that provides a way for users to view patient information on a hospital workstation that is connected via the hospital network. The server portion runs on a Windows server that is connected directly to the hospital Local Area Network (LAN) and to the Infinity Network. Data access methods are available as options that customers can purchase and enable independently once they install the basic Infinity Gateway application.

The Infinity Gateway Server facilitates the exchange of important clinical information between the Infinity/SDC protocol and existing hospital and patient care systems. The Infinity Gateway Server is designed to provide flexibility by using common healthcare protocols and data format standards for managing communications between multiple disparate systems. The user may select one or more Infinity Gateway Developer's Tools and Interface Options to create a seamless flow of information tailored to support clinical work flow.

Infinity Gateway Developer's Tools and Interface Options are licensed or "unlocked" by using option passwords that are associated with a USB license dongle. An option password is the electronic proof of purchase for the Infinity Gateway software. During the at-hospital setup procedure, the user will be asked for an option or license password which is a unique number associated with the licensing dongle issued. The licenses are always associated with the physical dongle. The Infinity Gateway developer's tools (such as WinAccess API) enable the development of custom applications to support customers' homegrown applications to support clinical research projects or downstream information systems. Finally, Infinity Gateway provides flexible deployment opportunities by leveraging the virtual machine technology, which facilitates cost-effective software deployments and reduces the total cost of ownership.

Infinity Gateway also promotes patient safety with efficient workflows for timely decisionmaking by integrating patient data and providing continuity-of-care support. Furthermore, it makes comprehensive clinical data available at the point-of-care by facilitating the exchange of lab reports and admission information between the Draeger Infinity Network and other hospital systems.

The provided text describes the regulatory clearance of Draeger Medical Systems, Inc.'s Infinity Gateway Suite (K203579) based on its substantial equivalence to a predicate device (K043549). This type of submission (510(k)) focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive de novo clinical trials typical of novel devices.

Therefore, the document primarily details the Device Description, Comparison of Technological Characteristics with Predicate Device, and Verification and Validation Testing necessary to establish substantial equivalence. It does not contain information about a diagnostic AI algorithm study with the typical acceptance criteria and study design details (e.g., sample sizes for test/training sets, blinding, expert adjudication, MRMC studies, ground truth establishment) that would be present in a submission for a novel AI/ML-driven diagnostic device.

The "Performance Data" section specifically states: "The verification and validation that was conducted confirmed the Infinity Gateway product performs according to intended use with no adverse effects upon other medical devices in the Infinity system to which it is connected. Testing confirmed that identified Product Risk mitigations functioned with the new code, with all test cases passing without exception." This refers to software engineering and functional integrity testing, not a diagnostic performance study as outlined in your request.

Given this, I cannot extract the specific information requested in your prompt as it pertains to a diagnostic AI study. However, I can summarize the closest relevant information from the provided text regarding the device's performance and verification:

Summary of Device Performance and Verification based on Substantial Equivalence (510(k) pathway):

The Infinity Gateway Suite (K203579) demonstrated its performance and met acceptance criteria through verification and validation testing confirming substantial equivalence to its predicate device (K043549).

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable / Not Stated: This document describes functional and software interface testing, not a diagnostic study requiring a "test set" of patient data in the typical sense. No mention of data provenance (country of origin, retrospective/prospective) is made.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable: The "ground truth" here is the functional correctness and safety of the software and its interfaces, validated through engineering tests against specified requirements and standards, not through expert clinical interpretation of diagnostic data.

4. Adjudication Method for the Test Set:

• Not Applicable: There was no "test set" requiring clinical adjudication. Software test cases either pass or fail based on predefined expected outcomes.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• No: This was not an MRMC study. The device is a data gateway and communication system, not a diagnostic AI intended to assist human readers in interpreting medical images or signals.

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

• Yes (in a functional sense): The verification and validation testing confirms the standalone functional performance of the software. However, this is not a diagnostic "algorithm only" performance as would be applicable to an AI model detecting disease. The device’s function is to facilitate data viewing and exchange among existing systems.

7. The Type of Ground Truth Used:

• Software Requirements and Engineering Specifications: The "ground truth" for this clearance is the device's adherence to its functional requirements, safety specifications, and relevant industry standards. Testing confirmed that the software met its intended functional specifications and that risk mitigations were effective.

8. The Sample Size for the Training Set:

• Not Applicable: This is not an AI/ML-driven diagnostic device that undergoes training on a data set.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable: As there's no training set for an AI model, this is not relevant.

In conclusion, the provided text details a 510(k) submission for a medical device software system focused on data connectivity and exchange. The "acceptance criteria" and "study" described are in the context of software verification and validation, ensuring functional integrity and safety for its intended use, rather than a diagnostic performance study of an AI algorithm.

Ask a specific question about this device

The Infinity MultiView WorkStation, Infinity Network and Remote Display are intended for use as a central monitoring device, communications network, and remote display for Draeger patient monitoring systems and recorders.

The Infinity Gateway Suite software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

The Infinity Gateway Suite (K014213/K030657) is a server-based software application that provides a connection to the Infinity Network and the hospital network infrastructure for the data exchange of select clinical and administrative information. The Infinity Gateway complies with healthcare information protocols to support data sets of many different sources, including medical devices, hospital information systems, clinical information systems, and laboratory systems.

Infinity Gateway includes a suite of software products to support the unique needs of hospitals, and provide a complete range of options for information connectivity:

• . Server Software
• . Interface Software Options
• Developers Tools .
• Remote View Applications 해
• . Pager Interface

The primary modification included in the VF4 software release of the Infinity Gateway Suite is the visual display of alarms on WinView and WebViewer.

I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, or any studies conducted on the Infinity Gateway Suite. The document is a 510(k) summary and FDA clearance letter, which describes the device, its intended use, and indicates that verification and validation testing was performed to establish equivalence to previous versions, but does not provide details of such testing or specific performance metrics.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

Ask a specific question about this device

Siemens MultiView WorkStation, INFINITY Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Siemens Patient Monitoring Systems and recorders.

The Infinity Gateway Suite software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

The Infinity Gateway Suite (K014213) is a server-based software application that provides a connection to the Infinity Network (K955059) and the hospital network infrastructure for the data exchange of select clinical and administrative information. The Infinity Gateway complies with healthcare information protocols to support data sets of many different sources, including medical devices, hospital information systems, clinical information systems, and laboratory systems.

Infinity Gateway includes a suite of software products to support the unique needs of hospitals, and provide a complete range of options for information connectivity:

• Server Software
• Interface Software Options
• Developers Tools ●
• Remote View Applications
• Pager Interface .

The primary modification included in the VF2 software release of the INFINITY Gateway Suite is the option for the Infinity Gateway Pager Interface. The pager interface transmits select alphanumeric monitor alarm data to paging service providers that support the Telocator Alphanumeric (TAP) Protocol, Revision 1.7 and European Standard Paging Application (ESPA) Protocol. Revision 4.4.4

This document is a 510(k) summary for the INFINITY Gateway Suite, VF2. It focuses on regulatory approval and does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information from the given text. The document primarily describes the device, its intended use, and its classification, concluding with an FDA approval letter based on substantial equivalence to a predicate device. It lacks specific performance metrics that would typically be found in a study summary.

Ask a specific question about this device

Siemens MultiView WorkStation, INFINITY Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Siemens Patient Monitoring Systems and recorders.

The Infinity Gateway Suite software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

The Infinity Gateway Suite is a server-based software application that provides a connection to the Infinity Network (K955059) and the hospital network infrastructure for the data exchange of select clinical and administrative information. The Infinity Gateway complies with healthcare information protocols to support data sets of many different sources, including medical devices, hospital information systems, clinical information systems, and laboratory systems.

Infinity Gateway includes a suite of software products to support the unique needs of hospitals, and provide a complete range of options for information connectivity:

• Server Software 1
• . Interface Software Options
• Developers Tools 내
• Remote View Applications B

I am sorry; this document does not contain the information requested. This document is a 510(k) summary for the INFINITY Gateway Suite, a software application, and as such, it does not include details on acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The document primarily focuses on the device description, intended use, and its substantial equivalence to a predicate device.

Ask a specific question about this device