(245 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.
Option Hi/Lo FiO2: The High/low FiO2 option of the Vyntus CPX is designed to measure the ventilation and the gas exchange (02 uptake, CO2 production) of a subject with varying inspiratory concentrations of O2.
This document primarily details a 510(k) premarket notification for the Vyntus/SentrySuite Product Line, specifically focusing on the addition of an option for High/Low FiO2. The submission aims to demonstrate substantial equivalence to previously cleared devices.
Here's an analysis of the provided text with respect to your requested information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a numerical or target performance metric for each characteristic. Instead, it refers to passing "applicable tests and standards" and meeting "user needs and design inputs." The performance data section focuses on demonstrating the device meets the technical specifications and accuracy of its predecessors.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Flow measurement | Range: 0 - 15 L/s, Accuracy: 70 mL/s or 3% | Passed applicable tests and standards; Identical to predicate device |
| Volume measurement | Range: 0 - 10 L, Accuracy: 50 mL or 2% | Passed applicable tests and standards; Identical to predicate device |
| Ventilation | Range: 0 - 300 L/min, Accuracy: 0.5 L/min or 2% | Passed applicable tests and standards; Identical to predicate device |
| V'O2, V'CO2 | Range: 0 - 7 L/min, Accuracy: 0.05 L/min or 3% | Passed applicable tests and standards; Identical to predicate device |
| RER | Range: 0.6 - 2.0, Accuracy: 4% | Passed applicable tests and standards; Identical to predicate device |
| Hi/Lo FiO2 Capability | Premixed inspiratory gases up to 100% O2 from manually filled bag | Passed applicable tests and standards; Identical to reference device (K992214) |
| Basic Safety | Compliance with IEC 60601-1 | Passed the applicable tests and standards |
| EMC Compatibility | Compliance with IEC 60601-1-2 | Passed the applicable tests and standards |
| Risk Management | Compliance with ISO 14971 | Passed the applicable tests and standards |
| Usability | Compliance with EN 62366 | Passed the applicable tests and standards |
| Software life cycle | Compliance with ISO 62304 | Passed the applicable tests and standards |
| Biocompatibility | Compliance with ISO 10993-1 | Passed the applicable tests and standards |
| Accuracy Testing | Accuracy of measurement (specifics not detailed for this general criteria) | Passed the applicable tests and standards |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench performance data and compliance with standards. It does not mention a specific "test set" in terms of patient data or a clinical study for the new High/Low FiO2 option. The testing appears to be centered on engineering and regulatory compliance rather than clinical performance data from a patient sample. Therefore, there is no information provided regarding sample size, country of origin, or retrospective/prospective nature of data for a clinical test set.
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)
Given that clinical testing was not performed (stated explicitly), there is no information about experts used to establish ground truth for a clinical test set. The performance data is based on engineering tests against established technical specifications for pulmonary function devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical test set is described, there is no information on an adjudication method for a test set.
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 submission is for a pulmonary function and cardio-pulmonary exercise testing device, not an AI-assisted diagnostic or interpretive system in the context of "human readers." While the Vyntus ECG component does offer automatic analysis and "suggestions for the interpretation," the document states these are "partial qualitative information" and "no therapy or drugs can be administered based solely on the interpretation statements." Furthermore, for the new option, no MRMC comparative effectiveness study is mentioned, nor is any AI assistance or effect size on human readers discussed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
While the device includes software with automated analysis for ECG, the focus of this submission is on the added High/Low FiO2 option for the CPX system and the overall compliance of the product line. No specific standalone performance study of an algorithm independent of the device's measurement capabilities is detailed. The performance testing section refers to "Accuracy Testing" as a general item but does not specify a standalone algorithm performance study.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the technical performance tests discussed (flow, volume, ventilation accuracy), the ground truth would typically be established by reference standards or highly accurate calibration devices that measure these physical parameters precisely. The document refers to "applicable tests and standards" for accuracy testing. For the non-clinical tests (safety, EMC, risk management, usability, software life cycle, biocompatibility), the ground truth is simply compliance with the respective international standards (e.g., IEC 60601-1, ISO 14971). There is no mention of ground truth based on expert consensus, pathology, or outcomes data, as clinical testing was not performed for this submission.
8. The sample size for the training set
The document states, "Clinical testing was not performed with this device." Therefore, there is no information on a training set or its sample size as no clinical data appears to have been used for an algorithm development for this specific submission's context.
9. How the ground truth for the training set was established
As no clinical training set is mentioned, there is no information provided on how ground truth for a training set was established.
§ 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).