(19 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 to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
The Philips SureSigns VSV (Vital Signs Viewer) is a device for central monitoring of multiple patients. The modification is a change that provides support for the Philips SureSigns VM Series Patient Monitors.
The provided text describes a 510(k) summary for the Philips SureSigns VSV (Vital Signs Viewer) and its substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria, study methodologies, or performance metrics in a quantitative sense. The summary primarily focuses on regulatory aspects, substantial equivalence, and general statements about testing.
Therefore, many of the requested details cannot be extracted from the provided input.
Here's what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance
The document explicitly states: "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that Philips SureSigns Vital Signs Viewer (VSV) functionality meets all reliability requirements and performance claims."
However, specific quantitative acceptance criteria (e.g., accuracy percentages, sensitivity, specificity, or error rates for arrhythmia detection) are not provided. Therefore, a table cannot be constructed with reported device performance against specific numerical criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the text. The document refers to "verification, validation, and testing activities" but does not detail the methodology for establishing ground truth or the involvement of experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the text.
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
This information is not provided in the text. The device is a "Vital Signs Viewer" and "Arrhythmia Detector and Alarm," implying automated functions. The text does not mention any studies involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The entire submission is for a device with automated functions ("Physiological Monitor, Patient Monitor," "Arrhythmia Detector and Alarm"). The "verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate." This implies a standalone assessment of the device's capabilities in detecting arrhythmias and monitoring vital signs. However, specific details of this "standalone" performance are not quantitatively reported.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the text.
8. The sample size for the training set
This information is not provided in the text.
9. How the ground truth for the training set was established
This information is not provided in the text.
Summary of available information:
The 510(k) summary indicates that the Philips SureSigns VSV underwent "Verification, validation, and testing activities" including "system level tests, integration tests, environmental tests, and safety testing from hazard analysis." The "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." The overall conclusion is that "Philips SureSigns Vital Signs Viewer (VSV) functionality meets all reliability requirements and performance claims."
However, critically, the document lacks specific numerical acceptance criteria and detailed quantitative performance results that would allow for a comprehensive answer to your request. The provided text is a summary statement for regulatory approval, focusing on substantial equivalence rather than a detailed scientific study report.
§ 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.