(29 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients.
Intended use: For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities.
EASI 12-lead ECG is only for use on adult and pediatric patients.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.
The Philips Medical Systems, M1275B Component Compact Monitor is a multi-parameter module.
The provided document, K020531 for the Philips Medical Systems M1275B Component Compact Monitor, does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria in the format typically required for AI/algorithm performance.
This 510(k) submission primarily focuses on establishing substantial equivalence to a previously cleared predicate device (K013199) rather than presenting a detailed performance study as one might expect for a novel AI/ML device. The document describes a traditional medical device (a multi-parameter monitor) and its updated multi-parameter module.
Here's a breakdown of the available information based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a specific table of acceptance criteria with corresponding performance metrics. Instead, it states:
"Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new 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. The results demonstrate that Component Compact Monitor meets all reliability requirements and performance claims."
This indicates that the acceptance criteria were the existing specifications and performance of the predicate device. The performance reported is that the new device met these predicate specifications and achieved substantial equivalence.
Regarding items 2-9, which are typically relevant for AI/ML performance studies, the document does not contain this information because it is not an AI/ML device submission. It's a hardware medical device. Therefore, the following information is not applicable or not provided in this 510(k) submission:
2. Sample size used for the test set and the data provenance: Not applicable. Performance was likely assessed through bench testing, simulated scenarios, and potentially limited clinical verification against existing monitors, but specific "test sets" of patient data as understood in AI/ML are not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physiological monitor would be established by physical measurements and calibrated equipment.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a hardware monitor, not an interpretive AI system that human readers would use in conjunction with.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is standalone in terms of its monitoring function, but this refers to a different context (AI algorithm performance) and is therefore not applicable to the information provided.
7. The type of ground truth used: For a multi-parameter monitor measuring physiological parameters (ECG, blood pressure, etc.), the ground truth would be established by comparison to other validated medical devices, calibrated sensors, and established physical measurement principles. The document states "Pass/Fail criteria were based on the specifications cleared for the predicate device," implying the predicate device's performance served as the benchmark.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
In summary:
This 510(k) submission for the Philips M1275B Component Compact Monitor, Release A.02, with M3001A Multi-Parameter Module, is for a traditional medical device (a physiological monitor). Its "acceptance criteria" and "proof" primarily revolve around demonstrating substantial equivalence to a previously cleared predicate device (K013199) and meeting the existing specifications and performance standards of that predicate. The document explicitly states that "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." The type of detailed performance study and ground truth establishment described in your request is specific to AI/ML devices and is therefore not found in this submission.
§ 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.