(65 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 Philips MP60, MP70, and MP90 IntelliVue Patient Monitor with Portal Technology and Wireless LAN. The modification is primarily a hardware based change that offers, as an option, the addition of an externally mounted wireless network connection to the Philips Medical System MP60, MP70 and MP90 IntelliVue patient monitor devices.
The provided text is a 510(k) summary for the Philips MP60, MP70, and MP90 IntelliVue Patient Monitors with Portal Technology and Wireless LAN. It describes the device, its classification, and asserts substantial equivalence to previously cleared devices. However, it does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria in the way a clinical performance study would.
Instead, the summary focuses on verification testing activities to establish performance and reliability characteristics, and safety testing from the risk analysis. This type of submission (510(k)) for a patient monitor and its wireless adapter typically relies on demonstrating substantial equivalence to existing devices through engineering and functional testing, rather than a clinical efficacy study with specific performance metrics against a ground truth as one might expect for an AI/ML diagnostic device.
Therefore, many of the requested fields cannot be filled from the provided text because such a study was not described.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Verification testing activities were conducted to establish the performance and reliability characteristics of the new device. Testing involved functional level tests and safety testing from the risk analysis."
However, no specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy for a particular physiological parameter) or their corresponding performance results are reported in this 510(k) summary. The submission focuses on demonstrating substantial equivalence to predicate devices, implying that if the new device performs similarly and meets safety standards, it is acceptable.
2. Sample size used for the test set and the data provenance
Not applicable. The document describes "functional level tests and safety testing," which are typically internal engineering and validation tests, not clinical studies with a "test set" in the context of diagnostic performance. There is no mention of patient data being used for a performance evaluation in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" derived from expert consensus for a clinical performance study is described.
4. Adjudication method for the test set
Not applicable. No clinical performance study requiring adjudication is described.
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
Not applicable. This device is a patient monitor with a wireless adapter, not an AI-based diagnostic tool. No MRMC study or AI-assistance evaluation is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a patient monitor, and its "performance" is inherent to its sensors and measurement capabilities, not a standalone algorithm in the sense of an AI/ML product.
7. The type of ground truth used
Not applicable. For this type of device (patient monitor), "ground truth" would generally refer to highly accurate reference measurements from calibrated equipment during functional testing, or clinical reference standards for physiological parameters. The summary doesn't detail the specifics of such ground truth used in their verification activities.
8. The sample size for the training set
Not applicable. This document pertains to a medical device (patient monitor with wireless capabilities), not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this document does not describe an AI/ML model with 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.