(17 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP20, MP30, MP40 and MP50 are intended for use in transport situations within additionally hospital environments.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.
The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitors. The modification is the introduction of Release B.1.2 software for the IntelliVue patient monitor devices and incorporating a ITS wireless interface.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
The provided document is a 510(k) summary for the Philips IntelliVue Patient Monitors, specifically for the introduction of Release B.1.2 software and a wireless interface. It focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel performance claims with specific acceptance criteria that would require a detailed standalone study.
Key takeaway: This submission relies on proving the updated device functions similarly to its predicates, implying that the predicate devices already met established performance standards. Therefore, the information typically requested for a de novo device's acceptance criteria and studies (like specific accuracy metrics, sensitivity/specificity, etc.) is not explicitly present in this summary.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or specific reported device performance metrics in the way a new device would for novel claims. Instead, it states that:
- "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate."
- "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence."
- "The results demonstrate that the Philips IntelliVue Patient Monitor meets all reliability requirements and performance claims."
This means the "acceptance criteria" were essentially that the modified device performed at least as well as the predicate devices for their established specifications. The "reported device performance" is implicitly that it achieved this equivalence across all tested aspects.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set in terms of patient data or specific clinical cases. The testing described is more focused on system-level validation and verification rather than clinical performance against a diagnostic gold standard in a typical study.
- Sample Size: Not specified.
- Data Provenance: Not specified. Since the testing is described as "system level tests, performance tests, and safety testing from hazard analysis," it's likely a mix of internal engineering tests, simulated data, and potentially some real-world operational testing, but not a large-scale clinical study with patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This type of submission, focused on software and interface modifications for an existing patient monitor, primarily involves engineering and regulatory assessment, rather than expert clinical review of novel diagnostic outputs.
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
Not applicable. As no human-in-the-loop diagnostic task or a specific clinical test set requiring expert adjudication is described, there's no mention of an adjudication method like 2+1 or 3+1.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document does not describe any study involving human readers or AI assistance, as the device is a patient monitor, not an AI-powered diagnostic tool.
6. If a Standalone Performance Study Was Done
A standalone performance study with explicit metrics (like sensitivity/specificity against a clinical gold standard) for a new algorithm was not performed or described. The performance assessment was centered on validating that the modified device maintains the performance, functionality, and reliability characteristics of its predicate devices. This includes "performance tests" at a system level.
7. The Type of Ground Truth Used
Given the nature of the device (patient monitor) and the submission's focus on substantial equivalence through software and interface updates:
- Ground Truth Type: For the "performance, functionality, and reliability," the ground truth would be the specifications and established performance of the predicate devices. This implies that the internal workings and outputs (e.g., heart rate readings, blood pressure measurements, alarm triggers) of the modified device were compared against the known, validated behavior of the older versions. It's an engineering and functional ground truth rather than a clinical diagnostic ground truth like pathology or outcome data.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device (patient monitor) with software updates, not an AI/Machine Learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of an AI/Machine Learning model or a training set.
§ 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.