Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments.
Additionally the M1011A S02 module together with the Philips S02 optical module is indicated whenever there is a need for continuous and invasive monitoring of the venous oxygen saturation.
The Philips 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 MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The monitors are not intended for home use. They are intended for use by health care professionals.
This 510(k) summary does not contain the specific details required to complete all sections of your request comprehensively. The document focuses on demonstrating substantial equivalence to predicate devices for patient monitors and the introduction of a new SO2 module and software revision. It largely relies on "verification, validation, and testing activities" without explicitly detailing the acceptance criteria, specific study design, or nuanced results you're asking for.
Here's an attempt to answer your questions based on the provided text, with significant caveats where information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific acceptance criteria (e.g., specific accuracy ranges for physiological parameters, alarm response times) or detailed reported device performance metrics in a quantitative manner.
Instead, it states: "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 means the acceptance criteria were implicitly those of the predicate devices, and the "reported performance" is a general statement of compliance rather than explicit numbers.
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 does not specify the sample size for any test set or the data provenance (country of origin, retrospective/prospective). It generally refers to "testing involved system level and regression tests, safety and performance tests, EMC and environmental tests."
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)
This information is not provided. The nature of the device (patient monitor) suggests that ground truth would likely be established through reference instruments or established clinical standards rather than expert consensus on interpretation of, for example, images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not indicated in this document. This type of study is typically used for diagnostic or interpretive AI devices where human readers would be involved in interpreting outputs. The Philips IntelliVue Patient Monitors are monitoring devices, and the evaluation would focus on the accuracy and reliability of the physiological parameter measurements themselves and the associated alarms. There is no mention of "human readers" or "AI assistance" in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes testing of the "modified devices" (which include a new SO2 module and software revision G.07 for the patient monitors). The testing described ("system level and regression tests, safety and performance tests, EMC and environmental tests") would inherently be a standalone evaluation of the device's performance against its specifications without explicit human-in-the-loop performance being a primary evaluation point. The device itself is designed to perform monitoring functions independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth is not explicitly stated. For physiological monitors, ground truth would typically come from:
- Reference standard instruments: Highly accurate and calibrated medical devices used to establish true physiological values.
- Simulated physiological signals: Controlled inputs representing various patient conditions.
- Clinical data paired with highly accurate manual measurements: In some cases, direct manual observation or measurement by trained clinicians using gold-standard techniques.
The document refers to "specifications cleared for the predicate devices," implying that the ground truth would be based on established measurements and performance expectations for the physiological parameters being monitored.
8. The sample size for the training set
This information is not provided. The document describes a "software revision G.07" but does not mention the use of machine learning or AI models that would typically require a training set in the way you might expect for an AI diagnostic device. The "software revision" is more likely related to traditional software engineering updates and bug fixes rather than an AI model requiring a training set of patient data.
9. How the ground truth for the training set was established
Since the document does not indicate the use of a "training set" in the context of machine learning/AI, this question is not applicable based on the provided text. The ground truth for the testing, as inferred above, would be based on reference standards for physiological measurements.
§ 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.