(71 days)
Visensia® with alert is an accessory to multi-parameter patient monitors (bedside, ambulatory, or centralized location) or clinical information systems and is indicated for use by health care professionals with those non-pediatric high dependency care patients for whom multi-parameter patient monitoring has been routine.
Visensia® provides the clinician with a patient status index (Visensia® Index) based on a weighted average of five or (four) vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The Visensia® Index is a single measure of a patient's condition and represents how different the patient's vital signs are with respect to normality. Visensia® is an adjunct to and is not intended to replace vital sign monitoring.
When a Visensia® alert has activated, it means that the Visensia® Index has reached and/or surpassed the default threshold and indicates that attention should be brought to the patient.
Visensia® software is a computerized analysis software program designed as an adjunct to standard patient monitors or medical information systems. It operates by forming an aggregate score of patient status based on five vital signs; heart rate; respiratory rate; temperature; noninvasive blood pressure and arterial oxygen saturation. The aggregate score, the Visensia® Index, is displayed on a scale of 0-5, with 0 representing the normal end of the scale and 5 representing extreme physiological deterioration. An audible and visual alert is provided when the Visensia® index exceeds a threshold value for a period of time. The Visensia® Index is calculated whenever new data is received.
The Visensia® display consists of a combination of the following:
- An identifier for each monitored patient and location .
- The Visensia® Index value for each patient (shown as a number, trend or other graphical . representation).
- The vital signs for each patient (shown as a number, trend or other graphical . representation).
- A status bar area showing the state of the system .
Visensia® may also be implemented as a data processing server with no graphical interface.
The provided document is a 510(k) summary for the Visensia® device, which is an adjunct to multi-parameter patient monitors for calculating a patient status index. However, it does not contain the specific details required to answer your request about acceptance criteria and the study that proves the device meets those criteria.
The document states:
- "The Visensia® Index is displayed on a scale of 0-5, with 0 representing the normal end of the scale and 5 representing extreme physiological deterioration."
- "An audible and visual alert is provided when the Visensia® index exceeds a threshold value for a period of time."
- "Visensia® provides the clinician with a patient status index (Visensia® Index) based on a weighted average of five or (four) vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The Visensia® Index is a single measure of a patient's condition and represents how different the patient's vital signs are with respect to normality."
It also mentions "Performance Testing" with "satisfactory results for the release" which involved:
- Unit Testing
- Integration Testing
- System Testing (on the completed product operating on representative hardware and communicating with a Philips MP30 patient monitor and an emulated clinical information system).
The document focuses on demonstrating substantial equivalence to its predicate device (K081140) by describing changes to features like alerts, the algorithm (re-factored but no change to design), data handling, and labelling, and confirming those changes did not alter the intended use.
Therefore, I cannot provide the detailed information requested regarding:
- A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) for the Visensia® Index or its alerts, nor does it present specific performance metrics from a study against such criteria.
- Sample size 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: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. The device is an "adjunct" and not replacing human monitoring.
- If a standalone study was done: The document describes system testing on the "completed product" but does not provide details of a standalone clinical performance study assessing its accuracy against a ground truth.
- The type of ground truth used: Not mentioned. Given the device provides an "index of patient status," a ground truth would likely involve clinical outcomes, expert assessment of patient deterioration, or some other validated metric of patient health status correlated with vital signs.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
In summary, this document is a Special 510(k) submission, confirming that modifications to an existing device (Visensia®) do not alter its safety or effectiveness compared to the predicate. It does not present new clinical study data with acceptance criteria for the device's diagnostic performance.
§ 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.