(199 days)
The intended use of the Philips Patient Information Center iX software application is to:
Receive, aggregate, process, distribute and display physiologic waves, parameters, alarms and events at locations other than at the patient, for multiple patients.
Determine alarm conditions and generate alarm signals for Philips approved medical devices, that send physiological data and do not have the ability to determine the alarm condition.
- Algorithms present in the software are limited to the ST/AR ECG (for arrhythmia, ST Segment and QT Segment Monitoring) and SpO2.
Generate alarm signals for user notification, based on the alarm signal determined and sent by Philips approved medical devices.
Perform diagnostic 12-Lead analysis and interpretation based on raw ECG data samples provided from Philips approved medical devices. Result may be displayed, printed and/or distributed to Philips approved medical devices.
Provide review and trend application data, designed to contribute to the screening of patient condition or visual indications provided are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making, thus these applications are not intended for diagnoses or active patient monitoring where immediate action is required.
Provide connection to other systems not associated with active patient monitoring, such as information systems. The software performs the action to transfer, store, convert from one format to another according to to display medical device data.
The Information Center Software is intended for use in professional healthcare facilities by trained healthcare professionals. The Information Center Software is not intended for home use.
Indicated for use when monitoring adult and/or specified pediatric subgroups (Newborn (neonate), Infant, Child, Adolescent) patients as indicated by labeling of the medical device providing the data. Rx only.
The Philips Patient Information Center uses off-the-shelf Windows PCs and servers, combined with the Patient Information Center iX M3290B software Release C.01 to provide centralized display of physiologic waves, parameters, and trends, format data for strip chart recordings printed reports, and secondary annunciation of alarms from other networked medical devices. The M3290B Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. Additionally, the M3290B Software provides primary annunciation of alarms and configuration and control access for networked telemetry monitors.
Compatible Accessories include: Mobile Caregiver – a medical device data system, viewing only, mobile application associated with the Enhanced Web Viewing feature cleared in the predicate. This is not a new mobile application, and it has no changes that introduce significant risks for the PIC iX C.01 release.
The provided document, a 510(k) premarket notification for the Philips Medical Systems "M3290B Patient Information Center iX Release C.01," primarily focuses on establishing substantial equivalence to a predicate device (M3290B Philips IntelliVue Information Center iX software Revision C.0). The document asserts that the changes in the new device do not introduce significant risks or new clinical applications requiring clinical performance testing. Therefore, it does not describe a clinical study in the traditional sense, particularly one involving an AI algorithm that would have specific acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or human-AI reader performance.
The device described is a patient information center software, which functions to receive, aggregate, process, distribute, and display physiological data, determine alarm conditions, generate alarm signals, and perform diagnostic 12-Lead analysis and interpretation. The algorithms mentioned (ST/AR ECG for arrhythmia, ST Segment, and QT Segment Monitoring) are present in the software but the performance evaluation described focuses on system-level testing and verification/validation to ensure it functions as intended and is as safe and effective as its predicate.
Based on the provided text, here is an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria in the form of specific performance metrics (like sensitivity, specificity, accuracy) for a new clinical application or AI algorithm, nor does it present reported device performance against such metrics. Instead, the acceptance criteria are implicitly tied to the system-level functional and safety requirements, and the reported performance is that the device "meets all defined reliability requirements and performance claims" and "test results showed substantial equivalence."
| Acceptance Criteria (Implicit from document) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device performs functions (receive, aggregate, process, distribute, display data, generate alarms, 12-Lead analysis) as intended and as demonstrated by the predicate device. | "Performance, functionality, and reliability characteristics of the new device with respect to the predicate are performed." |
| Safety: Device operates without introducing new or significant safety risks compared to the predicate. | "Testing involved system level tests, performance tests, and safety testing from hazard analysis." |
| "The M3290B Philips IntelliVue Information Center iX software Release C.01 meets all defined reliability requirements and performance claims." | |
| Reliability: Device maintains consistent and dependable operation. | "The M3290B Philips IntelliVue Information Center iX software Release C.01 meets all defined reliability requirements and performance claims." |
| Substantial Equivalence: Device is equivalent to the predicate in design, technology, intended use, safety, and effectiveness. | "M3290B Philips IntelliVue Information Center iX software Release C.01 is substantially equivalent to the predicate device M3290B Philips IntelliVue Information Center iX software Release C.O (K153702)." |
| Adherence to Specifications/Standards: Device complies with Philips' verification and validation processes, and relevant consensus standards. | "Tested in accordance with Philips verification and validation processes." |
| "Complied with the requirements specified in the international and FDA-recognized consensus standards." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states: "Clinical Performance testing for M3290B Philips IntelliVue Information Center iX software Release C.01 was not performed, as there were no new clinical applications that had hazards or risk mitigations that required a clinical performance testing to support equivalence."
Therefore, there is no specific test set or clinical data (sample size, provenance) described for evaluating the performance of the integrated algorithms. The testing was non-clinical, focusing on system-level verification and validation.
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)
Since no clinical performance study was conducted to evaluate the algorithms' diagnostic performance, there was no ground truth established by experts for a test set. The validation was against the defined specifications and the performance of the predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring expert adjudication was used.
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. The document explicitly states that clinical performance testing was not performed. This device is an information center, not an AI-powered diagnostic tool intended to directly assist human readers in image interpretation or a similar task where MRMC studies are typically conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document alludes to "Algorithms present in the software are limited to the ST/AR ECG (for arrhythmia, ST Segment and QT Segment Monitoring) and SpO2," and "Perform diagnostic 12-Lead analysis and interpretation". However, it does not describe a standalone performance study for these algorithms. The testing described is system-level verification and validation. The 12-lead analysis is stated to be "based on raw ECG data samples provided from Philips approved medical devices" and the "Result may be displayed, printed and/or distributed". The output data (e.g., from 12-lead analysis) is explicitly stated to "not be the sole source of information for decision making," indicating a human-in-the-loop context, but no study of this combined performance is presented.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical performance study requiring ground truth was conducted. The assessment relied on verifying that the system's output aligned with predefined functional specifications and matched the performance of the predicate device in a non-clinical testing environment.
8. The sample size for the training set
Not applicable. This document describes a software update for a patient information center, not a machine learning model requiring a training set. The existing algorithms are presumed to be validated from prior predicate device clearances.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning model is described.
§ 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.