(76 days)
The MR Patient Care Portal 5000 is intended for use by healthcare professionals. The device is indicated for use to monitor vital signs of patients undergoing MRI procedures including ECG, pulse oximetry (SpO2), non-invasive blood pressure (NIBP), and optionally, invasive pressure (IP), carbon dioxide (CO2) and respiration rate, anesthetic agents, nitrous oxide (N2O), oxygen (O2), and/or temperature based on the configurations of the host patient monitor with which the MR Patient Care Portal 5000 is wirelessly communicating. The target patient population includes adult, pediatric, and neonatal patients that require monitoring during MRI procedures.
The Philips MR Patient Care Portal 5000 is an information portal that serves as a remote monitor and remote control with electronic medical records capabilities outside the MR Scanner room (i.e. Control Room, Induction Room, or Recovery Room). The Philips MR Patient Care Portal 5000 displays the vital signs of a single patient monitoring system with which the device is communicating with from the MR control room.
The Philips MR Patient Care Portal 5000 is intended to replace the substantially equivalent device, the Expression Information Portal (Model IP5), cleared under 510(k) K121424 as a remote display and remote control for host patient monitoring systems, the Expression Model MR400 MRI Patient Monitoring System and Expression MR200 MRI Patient Monitoring System.
The Philips MR Patient Care Portal 5000 is not designed to be used in the MR Scanner room, does not perform any data collection or processing of data as stand-alone patient monitoring system, and it is not a central station.
The Philips MR Patient Care Portal 5000 system consists of the following primary components:
- Desktop unit;
- Radio Kit, USB;
- . Radio Cradle:
- Display, 18.5 inch;
The provided document is a 510(k) summary for the Philips MR Patient Care Portal 5000. This type of submission focuses on demonstrating substantial equivalence to a previously cleared device, not necessarily on proving novel clinical effectiveness or "improvement" with quantifiable effect sizes from clinical studies. The device in question is a remote display and control unit for vital signs monitors during MRI procedures, not a diagnostic AI device.
Therefore, the acceptance criteria and supporting studies are focused on safety, performance, and functional equivalence, rather than clinical diagnostic accuracy or reader improvement. The document does not contain the kind of detailed information about acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC), nor clinical study results (like MRMC studies for diagnostic accuracy, sample sizes for test sets in that context, ground truth establishment by expert consensus for diagnostic tasks) that your request implies.
Based on the provided document, here's an attempt to extract relevant information according to your template, acknowledging the differences in device type and regulatory pathway:
Device Name: Philips MR Patient Care Portal 5000
Device Type: Remote display and control for vital signs monitors (Cardiac Monitor)
Regulatory Pathway: 510(k) (Substantial Equivalence)
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI diagnostic device, the acceptance criteria are related to safety, functional performance, and equivalence to a predicate, not diagnostic metrics like sensitivity/specificity. The document states that the device "met performance, usability, and safety test acceptance criteria." Specific quantitative thresholds for these tests are not provided in this summary.
| Acceptance Criterion (Implicitly Derived from Regulatory Standards & Equivalence) | Reported Device Performance (Summary from Document) |
|---|---|
| Functional Equivalence to Predicate | - Same intended use and indications for use. |
| (Display of Vital Signs & Alarms) | - Same operating principle and conditions of use. |
| - Displays ECG, SpO2, NIBP, and optionally IP, CO2, respiration rate, anesthetic agents, N2O, O2, and temperature, matching what the host monitor transmits. | |
| - Time for vital sign information to be available between processing and viewing at the display is Less than one second. | |
| - Provides latched and unlatched visual and audible alarms compliant to IEC 60601-1-8. | |
| - Time for alarm conditions to be available between processing and viewing at the display is Two seconds. | |
| Electrical Safety | - Complies with ANSI AAMI ES60601-1 standard for safety. |
| Electromagnetic Compatibility (EMC) | - Complies with IEC 60601-1-2 standard for EMC. |
| Wireless Communication Performance | - Wireless and co-existence testing per US FCC CFR 47 Part 15 and FDA guidance was conducted to ensure safe and effective use. |
| Software Verification & Validation | - Software verification and validation testing conducted, documented per FDA guidance. |
| - Software Level of Concern: Major (due to vital signs/alarms for potentially life-threatening situations). | |
| Human Factors & Usability | - Tests conducted under 'simulated-use' per recognized consensus standards, industry standards, and FDA guidance. |
| - Evaluated user interaction, interpretation, and manipulation. | |
| - The graphical user interface (GUI) was updated to align with other Philips monitors for improved familiarity and ease of use, and this difference was determined not to affect substantial equivalence. | |
| Cleaning & Disinfecting Durability | - Designed to be cleaned and disinfected. Accelerated cleaning tests utilized worst-case scenarios; results support use of listed cleaners/disinfectants during device lifetime. |
| Lifetime/Service Life | - Defined lifetime of "7" years. Supported by worst-case usability scenario and cleaning durability testing under extreme conditions. |
| Environmental Performance (Transport/Storage/Operation) | - Tests conducted against extreme conditions (worst-case usage scenario) for subject device, components, and accessories. Results applicable to transport and storage. Intended environmental usage conditions will not exceed tested ranges. Slight differences in operating humidity, transport/storage, and atmospheric pressure temperatures compared to predicate were deemed not to affect substantial equivalence. |
| Material Composition | - Differences in material composition of main components compared to predicate (modular vs. integrated design) were deemed not to affect substantial equivalence, as no direct/indirect patient contact requires biocompatibility testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of diagnostic performance testing. The "test set" here refers to units of the device itself undergoing various non-clinical performance and safety tests. The document doesn't specify the number of physical devices or components tested for each non-clinical assessment (e.g., how many units were subjected to accelerated cleaning, or how many were involved in human factors testing).
- Data Provenance: The data described is from non-clinical performance testing (bench, safety, EMC, software V&V, human factors, cleaning/disinfecting, lifetime) of the device itself. There is no mention of patient data or clinical images. The testing would have been conducted by Invivo Corporation (a division of Philips Medical Systems) or their designated testing facilities.
- Retrospective/Prospective: All testing described is prospective as it's part of the development and verification/validation of the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This device is a monitor/display, not a diagnostic AI. There is no concept of "ground truth" (e.g., disease presence/absence in imaging) established by experts for a test set in the way you would for an AI diagnostic algorithm. The "truth" for functional tests is simply whether the device operates according to its specifications and regulatory standards.
4. Adjudication Method for the Test Set
- Not applicable. This relates to diagnostic image interpretations, which is not what this device does or what this submission is about.
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
- No. An MRMC study is not relevant for this type of device (a patient vital signs display) and was not conducted or required for this 510(k) submission. This type of study would be for evaluating diagnostic AI's impact on human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, not applicable in the requested context. The device itself is a component in a human-in-the-loop system (healthcare professionals monitoring patients). There is no "standalone algorithm" in the diagnostic sense. The device's "performance" is its ability to accurately display information and meet safety standards.
7. The Type of Ground Truth Used
- Not applicable in the requested context. The "ground truth" for this device's evaluation is primarily its adherence to engineering specifications, recognized safety and performance standards (e.g., IEC 60601 series, FCC), and functional equivalence to its predicate device. This is defined by technical standards and engineering verification, not by expert consensus on clinical cases, pathology, or outcomes data from patients the device is used on.
8. The Sample Size for the Training Set
- Not applicable in the AI sense. This document does not describe an AI/machine learning model that requires a "training set" of data. The device is hardware and software designed to perform a specific data display and control function.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no AI training set, there is no ground truth establishment for such a set described.
§ 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).