(14 days)
Indicated for central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
M3290A IntelliVue Information Center Software Release G.00 (for DataBase Server with Alert Data Integration)
The provided 510(k) summary (K050742) for the M3290A IntelliVue Information Center Software Release G.00 primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain specific acceptance criteria and detailed study results in the format requested.
The summary 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, integration tests, environmental 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 web software interface functionality meets all reliability requirements and performance claims."
This indicates that testing was performed and that pass/fail criteria existed, but these criteria and the specific performance results are not detailed in the provided document. The document primarily attests to the fact that such testing was done and that the device was found to be substantially equivalent to its predicate.
Therefore, I cannot populate the table or provide detailed responses to most of the specific questions as the information is not present in the provided text.
The following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: While the document states "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence," the specific criteria and performance metrics are not provided.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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 mentioned. This device is described as software for an "Information Center" and "Physiological Monitor," not specifically an AI-powered diagnostic tool, so an MRMC study might not be applicable or expected in this context.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not mentioned.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
§ 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.