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This device is capable of displaying physiological parameters received from Infinity Modular monitors and visually displaying alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system. The device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The Infinity Explorer is a software-driven application that allows the user to extend the viewing capability of the Infinity modular monitors and integrate additional patient information on a single display. Infinity Explorer is capable of displaying real-time patient data, providing control back to the bedside and integrating other applications with patient data on the PC. This Special submission includes minor modifications to the hardware and software.

The provided text describes a 510(k) summary for the Draeger Medical Systems, Inc. Infinity Explorer, a critical care workstation. However, it does not include detailed information regarding specific acceptance criteria, a standalone study proving device performance against those criteria, or an MRMC comparative effectiveness study with AI.

Here's the information that can be extracted and a clear statement of what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not provide a table with specific, quantifiable acceptance criteria (e.g., accuracy, reliability, latency) and corresponding reported performance metrics for the device. The statements are general and qualitative about overall performance and equivalence to previous versions.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Not applicable as the document does not mention a "test set" in the context of expert review for ground truth establishment. The testing described is for "overall performance" and "verification and validation" of the device's functionality and safety, not for diagnostic accuracy evaluated against expert-established ground truth.

4. Adjudication Method for the Test Set

• Not applicable for the same reason as above.

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

• No MRMC comparative effectiveness study is mentioned. This device is a critical care workstation for displaying physiological parameters and DICOM images, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, an MRMC study with AI assistance is not relevant to the described device.

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

• The document states: "Testing has been performed to verify the overall performance of the INFINITY Explorer with VF6 modifications and the new MDS III." and "Verification and validation testing performed indicate that the modifications implemented are as safe and effective as previous versions and have not altered the fundamental technology of the device(s)."
• This suggests standalone testing of the device's functionality and performance as an integrated system, but it's not a "standalone (algorithm only)" study in the context of AI diagnostic algorithms. It's a system performance validation.

7. The Type of Ground Truth Used

• Not applicable in the context of diagnostic accuracy for this device. The "ground truth" for the verification and validation testing would be the expected functional behavior and safety requirements of the device's components and system as designed.

8. The Sample Size for the Training Set

• Not applicable. This device is a critical care workstation, not a machine learning model that requires a training set.

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

• Not applicable for the same reason as above.

Summary of Missing Information:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and verifying that modifications do not alter the fundamental technology or safety. It lacks specific details regarding quantitative acceptance criteria, explicit performance metrics against those criteria, or any studies involving expert review for diagnostic accuracy or AI performance. The nature of the device (a critical care workstation) explains why many of these specific AI-centric questions are not applicable to the content provided.

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This device is capable of displaying physiological parameters received from INFINITY Modular monitors and visually displaying alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system.

The device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The device is intended for use with the adult, pediatric and neonatal populations.

The INFINITY EXPLORER is a software-driven application that allows the user to extend the viewing capability of the Infinity modular monitors and integrate additional patient information on a single display. INFINITY EXPLORER is capable of displaying real-time patient data, providing control back to the bedside and integrating other applications with patient data on the PC. The VF4 modifications include:

• New MDSII Hardware
• New user interface with enhanced monitor applications

The provided text is a 510(k) summary for the INFINITY Explorer with VF4 and MDS II. It describes a software-driven application that extends the viewing capability of physiological monitors. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria, a common component of performance testing for AI/ML-enabled devices. The submission is for a device modification of an existing product, and focuses on general device functionality, safety, and regulatory compliance rather than performance metrics of the device as related to a specific diagnostic or prognostic task.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
• If a standalone performance (algorithm only) study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

What is present in the document is a statement regarding non-clinical performance data:

"Assessment of non-clinical performance data for equivalence: Testing in accordance with internal design control procedures indicates no new issues relative to safety and efficacy for INFINITY EXPLORER with software version VF4 and the new MDS II."

This statement indicates that internal testing was conducted, but it does not provide specific acceptance criteria, study details, or performance metrics. It also explicitly states "Assessment of clinical performance data for equivalence: Not applicable," implying that no standalone clinical performance study was deemed necessary for this specific device modification under the 510(k) pathway.

This type of submission is common for minor modifications to existing medical devices where the primary focus is to ensure that the changes do not introduce new safety or efficacy concerns, rather than to establish or re-establish performance against specific clinical endpoints.

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