(119 days)
The INFINITY Modular Monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. These devices will connect to an R50 Bedside recorder, either directly or via the INFINITY Network.
The INFINITY Modular monitors are capable of monitoring:
- Heart rate
- Respiration rate
- Invasive pressure
- Non-invasive pressure
- Arrhythmia
- Temperature
- Cardiac output
- Arterial oxygen saturation
- Pulse rate
- Apnea
- ST Segment Analysis
- 12-Lead ST Segment Analysis
- tcp02/tcpC02
- EEG signals
- FiO2
The SCIO and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas modules continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, halothane, isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.
With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored. The monitors can interface with specific third party devices via an MIB protocol converter.
The VF4 release of the INFINITY Modular monitors supports the "look and feel" of the Draeger Medical product line, including the Draeger logo, colors, menu structure, and physical form. An alarm indicator has been added to the top center of the device that illuminates in red or vellow for the purpose of displaying both life threatening and serious alarms respectively.
Additional minor software modifications have been implemented that primarily address customer requested enhancements.
The provided text is a 510(k) summary for the INFINITY Modular Monitors with VF4 Modifications. This document describes a modification to an existing medical device and focuses on demonstrating that the modified device is as safe and effective as its predicate device. It does not contain information about the development and testing of a new AI/Machine Learning algorithm for a diagnostic or predictive task.
Therefore, many of the requested criteria related to performance metrics, sample sizes for AI model training/testing, expert consensus for ground truth, and MRMC studies are not applicable to this document as it describes a software and hardware update to a physiological monitor, not an AI-powered diagnostic device.
Here's an analysis of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, or accuracy) for any particular function. This is because it is a submission for modifications to an existing physiological monitor, not a new diagnostic algorithm. The acceptance "criteria" in this context would be that the modified device remains "as safe and effective" as the predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| "as safe and effective as the previous released versions of the monitors" | "Testing in accordance with internal design control procedures has verified that the INFINITY Modular Monitors with VF4 modifications are as safe and effective as the previous released versions of the monitors." |
Other Requested Information (Not Applicable or Not Provided in this Document)
The following points are largely not applicable to this 510(k) submission, as it focuses on demonstrating equivalence of a modified physiological monitor rather than the performance of a new AI-powered diagnostic or predictive algorithm.
- Sample size used for the test set and the data provenance: Not applicable. The document refers to "testing in accordance with internal design control procedures" but does not specify sample sizes of patients or data, nor the provenance of such data, as would be expected for an AI performance study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of expert consensus for ground truth as this is not a diagnostic AI device.
- Adjudication method for the test set: Not applicable.
- 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. The device is a physiological monitor, not an AI assistance tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for a standalone AI algorithm performance, however, the "Verification and validation testing of VF4 software, as well as testing applicable to the hardware modifications" implies standalone testing of the modified device's functionality.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of a diagnostic ground truth. The "ground truth" would be the expected functional performance of the monitoring parameters based on engineering specifications and validated medical standards.
- The sample size for the training set: Not applicable. This document does not describe the development of an AI model, and therefore, no training set for an algorithm.
- How the ground truth for the training set was established: Not applicable.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.