(141 days)
The Vyntus/SentrySuite Product Line is intended to be used for measurements, data collection and analysis of lung function (PFT) and cardio-pulmonary (CPET) parameters, aiding in the diagnosis of related conditions. The results of the test can be viewed online with the help of a computer screen and can be printed after the test results can be saved for future reference or report generation purposes.
The products can be utilized with patients age 4 years and older as long as they can cooperate in the performance - no special limit to patient's sex or height exists. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities).
A qualified physician has to reassess all Vyntus/SentrySuite measurements. An interpretation by Vyntus/SentrySuite is only significant if it is considered in connection with other clinical findings.
Additional for Vyntus ECG:
The Vyntus ECG is intended for measuring the surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on the screen or printed on paper. 12-lead ECGs are analyzed automatically and suggestions for the interpretation of the resting ECG can be made by the software. ECG interpretation statements made by the Vyntus/ SentrySuite represent partial qualitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.
The Vyntus ECG can be used for non-interpretive applications in patients age 4 years and older and a weight of 20 kg or higher. The Vyntus ECG is intended to be used for routine ECG collection, recording both under resting and stress conditions. The measurement is performed by trained healthcare professionals under the direction of a physician in healthcare facilities (e.g. the doctor's office or hospital). The Vyntus ECG is not intended for intracranial use. The Vyntus ECG is not intended for use in an EMS environment (Emergency Medical Services Environment). The Vyntus ECC is not intended for use in home healthcare environments. Automatic interpretation of the ECG is not possible for pediatric and adolescent patients below 16 years of age and for patients with pacemakers.
The Vyntus ECG is the perfect 12-Lead PC-ECG extension for the Vyntus CPX via secure Bluetooth® communication. One integrated solution through the SentrySuite platform helps laboratories ease procedures and integration to reduce costs.
The Vyntus ECG records the full 12-lead resting and stress ECG via its wireless, battery operated ECG amplifier. The evaluation and interpretation is using the proven Hannover ECG System (HES).
Scientific Concept:
The surface electrodes of the Vyntus ECG record the electrical signals that are mainly generated by the heart muscle activity and repolarization. The small voltages are amplified and A/D converted. A low frequency high-pass filter is applied and the recorded signals are transmitted to the PC for recording, storing, evaluation, interpretation, display and reporting.
Significant performance characteristics:
- Full 12 lead ECG
- Small, low weight (
The provided text is a 510(k) Pre-Market Notification for the CareFusion Vyntus/SentrySuite Product Line, specifically for the Vyntus ECG component. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria in a detailed clinical study.
Therefore, the input document does not contain the detailed information required to fully answer the request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:
- A table of acceptance criteria and reported device performance for specific clinical metrics. The "Summary Table of Comparison" compares technological characteristics with predicate devices, not performance against acceptance criteria.
- Details on sample size, data provenance, number of experts, adjudication methods, or ground truth for a test set.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Details on the training set size or how its ground truth was established.
The document states: "Clinical testing was not performed with this device." This explicitly means there isn't a clinical study proving the device meets acceptance criteria in a real-world patient setting.
However, the document does list non-clinical tests and standards the device passed to demonstrate substantial equivalence, which can be interpreted as fulfilling certain "acceptance criteria" related to safety and technical performance.
Here's an attempt to answer based on the available (albeit limited for the specific request) information in the document, focusing on the non-clinical tests as proxies for "acceptance criteria" in the context of this 510(k) submission:
1. Table of acceptance criteria and the reported device performance
Based on the "Summary of Device Testing" section, the acceptance criteria are adherence to specified international standards, and the reported performance is that the device passed these applicable tests.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 14971 (Risk Management) | Passed |
| EN 62366 (Usability) | Passed |
| ISO 62304 (Software Life Cycle) | Passed |
| IEC 60601-1 & IEC 60601-2-25 (Basic Safety) | Passed |
| IEC 60601-2 (EMC Compatibility) | Passed |
| ISO 10993-1 (Biocompatibility) | Passed |
2. Sample size used for the test set and the data provenance
The document explicitly states: "Clinical testing was not performed with this device." Therefore, there is no clinical test set of patients, data provenance, or sample size described for evaluating clinical performance against acceptance criteria. The non-clinical tests are against the device itself and its components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical testing was performed, there was no clinical test set requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As no clinical testing was performed, there was no clinical test set requiring adjudication.
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
No MRMC study was mentioned or performed, as "clinical testing was not performed with this device." The device provides "suggestions for the interpretation" but the document states, "A qualified physician has to reassess all Vyntus/SentrySuite measurements. An interpretation by Vyntus/SentrySuite is only significant if it is considered in connection with other clinical findings." This implies the device is an aid, but no study on human improvement with this aid was presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions that the Vyntus ECG uses the "proven Hannover ECG System (HES)" for evaluation and interpretation. It states, "12-lead ECGs are analyzed automatically and suggestions for the interpretation of the resting ECG can be made by the software." This indicates a standalone algorithm for interpretation. However, the document does not provide performance metrics (e.g., sensitivity, specificity) for this standalone algorithm against a ground truth dataset. It only confirms the algorithm is incorporated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests (ISO, EN, IEC standards), the "ground truth" is adherence to the definitions and requirements specified within those objective technical and safety standards. For the built-in Hannover ECG System (HES) algorithm, the document does not specify how its internal ground truth was established or validated for its interpretation capabilities as part of this submission.
8. The sample size for the training set
Not applicable to this 510(k) submission. The document identifies the integrated "Hannover ECG System (HES)" as the evaluation and interpretation algorithm. The training set size for the development of HES itself is not provided in this regulatory document.
9. How the ground truth for the training set was established
Not applicable to this 510(k) submission. The method for establishing ground truth for the training set of the "Hannover ECG System (HES)" is not described in this regulatory document.
§ 868.1880 Pulmonary-function data calculator.
(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).