(28 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 healthcare environments. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within healthcare environments. ST Segment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcp02 / tcpCQ2) is restricted to neonatal patients only.
The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitors with 802.11 Wireless LAN. The modification is a change that creates, an optional, 802.11 wireless network adapter for the Philips MPxx IntelliVue patient monitors.
The provided 510(k) summary for the Philips IntelliVue Patient Monitors with 802.11 Wireless LAN does not contain detailed information about specific acceptance criteria and a study proving the device meets those criteria, as typically found for AI/ML-based medical devices.
Instead, this submission is for a modification (the addition of an 802.11 wireless network adapter) to existing patient monitors. The focus is on demonstrating substantial equivalence to previously cleared predicate devices, rather than a de novo evaluation of novel performance.
Here's a breakdown of what can be extracted and what is not present in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly detailed in the provided document in the context of specific quantitative metrics for the wireless LAN performance.
The document states: "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence."
This indicates that:
- Acceptance Criteria: Were based on "specifications cleared for the predicate device." These specific criteria (e.g., latency, throughput, signal strength, reliability) are not listed.
- Reported Device Performance: The summary states "test results showed substantial equivalence" and "The results demonstrate that the Philips IntelliVue Patient Monitor meets all reliability requirements and performance claims." No quantitative performance data for the wireless LAN is given.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided for the specific wireless LAN testing. The document generally refers to "system level tests, performance tests, and safety testing" without detailing the sample sizes (e.g., number of test cases, duration of tests, number of devices tested) or data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/not provided. The device is an integrated patient monitor with a wireless component, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth for its core function. The "ground truth" here would relate to engineering specifications and performance standards for wireless communication and patient monitoring, not clinical expert consensus on interpretations of data.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Similar to point 3, adjudication methods like 2+1 or 3+1 statistical consensus are typically used for clinical image or signal interpretation ground truth, not for evaluating the performance of a wireless network adapter in a medical device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
This information is not applicable/not provided. MRMC studies are used to assess the diagnostic performance of human readers, often with and without AI assistance, usually for interpreting medical images or complex data. This submission is for a hardware modification (wireless LAN) to a patient monitor, not a diagnostic AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/not provided. The device is a patient monitor, which operates with human interaction and is not solely an "algorithm" in the conventional AI sense. The wireless LAN is a component of a larger system.
7. The Type of Ground Truth Used
The "ground truth" for the testing described would be based on engineering specifications and established performance standards for patient monitoring devices and wireless communication. For example, standards for signal integrity, data transmission rates, latency, security, and reliability in a medical environment would serve as the ground truth against which the wireless LAN's performance was measured. No clinical outcomes data or pathology reports would typically be relevant for this type of device modification.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The document describes a hardware modification and associated performance testing, not the development or training of an AI/ML algorithm. Therefore, there is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as point 8.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).