(62 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. | "Testing has been performed to verify the overall performance of the INFINITY Explorer with VF6 modifications and the new MDS III." |
| Not explicitly stated in the document. | "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)." |
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.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).