(204 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
The Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP5 is also intended for use during patient transport outside of a hospital environment. The monitors are not intended for home use. They are intended for use by health care professionals.
The provided 510(k) summary (K093268) is for the Philips IntelliVue Patient Monitors, specifically for the introduction of software release G.08 which includes "enhancements in the Respiration algorithm." However, the document does not provide specific acceptance criteria or a detailed study proving the device meets those criteria for the respiration algorithm enhancement.
Instead, it states:
"Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicate. Testing involved system level and regression tests as well as testing from the hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results demonstrate that the Philips IntelliVue Patient Monitors meet all reliability requirements and performance claims."
This generic statement indicates that the new software release G.08 was evaluated against the existing specifications and performance claims of the predicate devices. It does not offer a new study with specific acceptance criteria, sample sizes, ground truth methodologies, or expert qualifications for the enhanced Respiration algorithm.
Therefore, many of the requested details cannot be extracted from this specific 510(k) summary. I will answer what is available and explicitly state when information is not present in the document.
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document. The document states "Pass/Fail criteria were based on the specifications cleared for the predicate devices," but it does not specify what those criteria are for the enhanced respiration algorithm or report specific performance metrics against them.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided document. The summary mentions "system level and regression tests" but does not provide details on the sample size or the nature of the test data (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable/available. This 510(k) summary does not describe a study involving expert-established ground truth for the enhanced respiration algorithm. The testing described is against existing predicate device specifications.
4. Adjudication Method for the Test Set
Not applicable/available. No information on an adjudication method is provided, as no expert review or medical decision-making process is described in the testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe a multi-reader, multi-case comparative effectiveness study involving human readers with and without AI assistance. The enhancement is to a "Respiration algorithm," which is typically a standalone calculation, not an AI-assisted interpretation for human readers in the context of this document.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, implicitly. The testing described ("system level and regression tests") would inherently evaluate the standalone performance of the algorithm against its specifications. However, specific details of a standalone study or its results are not provided in this summary. The statement "The results demonstrate that the Philips IntelliVue Patient Monitors meet all reliability requirements and performance claims" implies standalone testing for the algorithm's function.
7. Type of Ground Truth Used
Implicitly, engineering specifications/clinical standards of the predicate device. The document states "Pass/Fail criteria were based on the specifications cleared for the predicate devices." This suggests that the "ground truth" for evaluating the enhanced respiration algorithm would be its adherence to established performance parameters and accuracy benchmarks relevant to those predicate device specifications, rather than new pathology, expert consensus, or outcomes data.
8. Sample Size for the Training Set
Not applicable/available. As this document concerns a software enhancement to an existing device, and the testing is described as against predicate specifications, there is no mention of a "training set" in the context of, for example, a machine learning algorithm being developed from scratch. If the "enhancements" included adaptive or machine learning components (which is not stated), details about a training set would typically be provided.
9. How the Ground Truth for the Training Set Was Established
Not applicable/available. See point 8.
§ 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.