(86 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-paediatric 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 9 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 with Alert is an adjunct to and is not intended to replace vital sign monitoring and as such does not contain alarms, but alerts the physician to changes in the patient's physiological status.
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® is a software accessory to standard multiple parameter physiological patient v benturs (bedside or ambulatory) or clinical information systems. It operates on a standard PC, or personal computer.
Visensia® is a software device that through advanced signal processing can combine physiological signals in order to produce a single index (Visensia® index) representation of patient condition.
Visensia® is a computerized analysis system that can accept multiple channels of Prisonological data (for example heart rate, respiratory rate, temperature, blood pressure and oxygen saturation as inputs). Through advanced signal processing, Visensia® can identify changes in patient status.
The provided text describes Visensia® with Alert, a software accessory that generates a "patient status index" (Visensia® Index) based on vital signs. It also has an alert function to indicate changes in a patient's physiological status.
Here's an analysis of the acceptance criteria and study information, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for the device's performance (e.g., a specific sensitivity or specificity for detecting patient deterioration). Instead, it focuses on design verification and validation, and clinical data showing effectiveness.
Therefore, the table will reflect the general statements made about performance:
| Acceptance Criteria (Implicit/General Statements) | Reported Device Performance (Summary from text) |
|---|---|
| Device meets specified requirements. | Design verification testing confirmed Visensia® hardware and software meet specifications. |
| Device specifications conform with user needs and intended use. | Design validation testing concluded device specifications conformed with user needs and intended use for the index model. |
| Effectiveness of Visensia® for patient status indexing. | Clinical data illustrates the effectiveness of Visensia® and its usefulness. |
| Effectiveness of the alert function in correlation with patient deterioration. | Clinical data correlates patient deterioration with the alerting function. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical Testing: Clinical data illustrates the effectiveness of Visensia and the usefulness of he alert function. The data correlates patient deterioration with alerting function."
- Sample Size for Test Set: Not specified in the provided text. The document only generally mentions "Clinical data."
- Data Provenance: Not specified in the provided text. It does not mention the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical testing.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided text. The document focuses on the device's standalone performance and its clinical utility rather than comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance assessment was conducted, implied by the "Performance Studies" section.
- "Design verification: Design verification testing of Visensia® hardware and software against the specified requirements has been conducted and Visensia® has been found to meet the specifications."
- "Design validation: Design validation testing of Visensia® index model has been conducted and concluded that device specifications conformed with user needs and intended use."
- "Clinical Testing: Clinical data illustrates the effectiveness of Visensia and the usefulness of he alert function. The data correlates patient deterioration with alerting function."
These statements suggest that the algorithm's performance in generating the index and alerts was evaluated, independently of human interpretation, though the specifics of this evaluation are limited.
7. Type of Ground Truth Used
The document indicates that the "Clinical data illustrates the effectiveness of Visensia and the usefulness of he alert function. The data correlates patient deterioration with alerting function."
This implies that the ground truth for clinical testing was based on observed "patient deterioration" as determined by clinical assessment. However, the specific methodology for defining and confirming "patient deterioration" (e.g., specific clinical outcomes, physician diagnosis, or a composite score) is not detailed.
8. Sample Size for the Training Set
The document makes no mention of a "training set" or its sample size. The description of the device's development implies that the model for the Visensia® Index was developed and refined using historical clinical data, as stated in the substantial equivalence comparison to Sonicaid System 8002: "Visensia®... provides decision support to a clinician in the determination of normality based on a model derived from historic clinical data." However, the size of this historical dataset is not provided.
9. How the Ground Truth for the Training Set Was Established
The document indicates that the model for determining normality was "derived from historic clinical data." Analogous to the predicate device Sonicaid System 8002 where "criteria were established by examination of historical clinical data." This implies that the ground truth for developing the model was based on retrospective analysis of historical clinical data, likely interpreted by experts or defined by established clinical criteria for "normality" or "patient status." However, the specifics of how this ground truth was established (e.g., number of experts, specific criteria) are not detailed.
§ 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.