(60 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 additionally intended for use in transport situations within hospital environments.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCQz) is restricted to neonatal patients only.
The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors. The modification is the introduction of Release C.01 software for the IntelliVue patient monitor devices.
The provided text describes a 510(k) submission for Philips IntelliVue Patient Monitors (MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90), Release C.01 software. It focuses on demonstrating substantial equivalence to previously cleared predicate devices through verification, validation, and testing activities.
However, the document does not contain specific acceptance criteria, detailed device performance metrics in a quantitative table, or information about a study proving the device meets those criteria in the way typically expected for an AI/CADe device. Instead, it states that "performance criteria were based on the specifications clear for the predicate device and test results showed substantial equivalence."
Based on the provided text, the following information can be extracted/inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table with specific quantitative acceptance criteria or reported device performance metrics in the format requested (e.g., sensitivity, specificity, accuracy with numerical targets). It broadly states:
| Acceptance Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|
| Meet specifications of predicate devices. | Test results showed substantial equivalence to predicate devices. |
| Fulfill performance claims and reliability requirements. | Philips IntelliVue Patient Monitor meets all reliability requirements and performance claims. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The testing involved "system level tests, performance tests, and safety testing from hazard analysis," but the nature of the data (patient data, simulated data, etc.) is not detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided as the validation appears to be against predicate device specifications and internal testing, not explicitly against an expert-established ground truth on a clinical test set.
4. Adjudication Method for the Test Set:
- This information is not provided. The assessment method described is focused on meeting predicate device specifications and internal performance/safety tests, not an expert panel adjudication of results from a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improving with AI vs. without AI assistance:
- No, an MRMC comparative effectiveness study was not explicitly mentioned or implied. The document focuses on the substantial equivalence of the new software release to predicate devices, not on the improvement of human readers with AI assistance. The devices are patient monitors, not specifically AI-driven diagnostic tools in the context of human reader improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document describes "performance tests" and "system level tests." While these imply evaluation of the device's functionality (algorithm only), it doesn't explicitly refer to "standalone performance" in the way it's often used for AI/CADe devices to differentiate it from human-in-the-loop performance. However, given that these are patient monitors, their primary function is to continuously monitor and alarm, which is inherently an "algorithm only" function in terms of detecting physiological parameters and triggering alarms according to programmed thresholds.
7. The Type of Ground Truth Used:
- The ground truth used for validation is implicitly the established performance specifications and accepted functionality of the predicate devices. The new software (Release C.01) was tested to ensure it met these existing benchmarks. It is not based on expert consensus, pathology, or outcomes data from a new clinical study.
8. The Sample Size for the Training Set:
- Not applicable/Not provided. This is a software release for patient monitors, not a machine learning model that undergoes a distinct "training" phase with a large dataset. The "training set" concept is typically associated with AI/ML development, which is not described here.
9. How the Ground Truth for the Training Set was Established:
- Not applicable/Not provided. As there is no mention of a training set in the context of an AI/ML model, the establishment of its ground truth is not discussed.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).