(172 days)
The Vyntus ONE / 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 aged 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 ONE / 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 ECG 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 ONE is a full pulmonary function test (PFT) system, consisting of a main unit with the gas analyzers and electronics inside, a patient interface with a Flow Path Valve eDemand and an electronic demand valve inside and an ultrasound flow sensor (USS). The entire equipment is mounted on a cart which includes the isolation transformer and the support arm for the patient interface and the USS.
The Vyntus ONE is connected via USB interface to the desktop PC and enables the following standard measurements:
- Diffusion SB Realtime
- Diffusion SB Intra-breath
- FRC N2 washout
- Slow/forced spirometry and MVV
The Vyntus ONE also supports cardiopulmonary exercise testing (CPET). The specific hardware consists of the light-weight digital volume transducer (DVT) and an optional SpO2 pulse oximeter. It enables the following standard measurement features:
- Breath-by-breath (BxB) gas exchange
- Workload control for bicycle ergometer or treadmills
- Automatic workload protocols
Further optional hardware and software include:
- Vyntus ECG: 12-lead Electrocardiogram (ECG) recording (resting and stress ECG)
- ROcc, P0.1, MIP / MEP measurements
The Vyntus ONE device, a full pulmonary function test (PFT) system, was evaluated through non-clinical tests to determine its substantial equivalence to predicate devices. No clinical tests were performed.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Risk Management | ISO 14971 | Pass applicable tests and standards | The proposed device passes the applicable tests and standards |
| Usability | EN 62366 (IEC 60601-1-6 and related IEC 62366) | Pass applicable tests and standards; Usability Engineering File & Usability report | The proposed device passes the applicable tests and standards |
| Software Life Cycle | ISO 62304 | Pass applicable tests and standards | The proposed device passes the applicable tests and standards |
| Basic Safety | IEC 60601-1 | Pass applicable tests and standards | The proposed device passes the applicable tests and standards |
| EMC Compatibility | IEC 60601-2 | Pass applicable tests and standards | The proposed device passes the applicable tests and standards |
| Biocompatibility | ISO 10993 | Pass applicable tests and standards | The proposed device passes the applicable tests and standards |
| Accuracy Testing | Measurement effectiveness & accuracy | Pass applicable tests and standards | The proposed device passes the applicable tests and standards |
| Climatic Chamber Test | Environmental testing according specifications (Temperature: +10° to 34°C, Relative humidity: 20 to 80%, Barometric pressure: 700 to 1060 hPa) | Pass applicable tests and standards | The proposed device passes the applicable tests and standards |
| ATS / ERS | Standard for lung function testing | Fulfill ATS/ERS standard | The proposed device passes the applicable tests and standards |
| Flow Accuracy (exh.) | Ultrasonic Flow Sensor | 0 to 14 L/S: 1.5% or 0.05 L/S (whichever is greater) | Actual performance met or exceeded this, as the new device is stated to be "more accurate in flow and volume". |
| Flow Accuracy (inh.) | Ultrasonic Flow Sensor | 0 to 14 L/S: 2.5% or 0.05 L/S (whichever is greater) | Actual performance met or exceeded this, as the new device is stated to be "more accurate in flow and volume". |
| Flow Range | Ultrasonic Flow Sensor | 0 to 18 L/S bidirectional | The document states the new technology improved the maximum ranges slightly. "insignificant difference as the ranges are higher than a patient can breathe." |
| Flow Resolution | Ultrasonic Flow Sensor | 1ml/s | Actual performance met or exceeded this, as the new device is stated to have a "higher flow resolution." |
| Volume Accuracy (exh.) | Ultrasonic Flow Sensor | 0 to 14L: 1.5% or 0.05L (whichever is greater) | Actual performance met or exceeded this, as the new device is stated to be "more accurate in flow and volume". |
| Volume Accuracy (inh.) | Ultrasonic Flow Sensor | 0 to 14L: 2.5% or 0.05L (whichever is greater) | Actual performance met or exceeded this, as the new device is stated to be "more accurate in flow and volume". |
| Volume Range | Ultrasonic Flow Sensor | +/- 30 L (software limited) | The document states the new technology improved the maximum ranges slightly. "insignificant difference as the ranges are higher than a patient can breathe." |
| Volume Resolution | Ultrasonic Flow Sensor | 1ml | Actual performance met or exceeded this, as the new device is stated to have a "higher flow resolution." |
| Patient Interface Material | Biocompatibility (ISO 10993) | Tested completely according to ISO 10993 | New FPV (Flow Path Valve) uses new material tested for Cytotoxiticity, sensitization, irritation, intracutaneous reactivity, acute systemic toxicity, material mediated pyrogenicity, and Chemical Characterization (Exaggerated Extraction FTIR HPLC-MS / UPLC-MS GC-MS Headspace GC-MS ICP-MS ICP-OES). |
2. Sample size used for the test set and data provenance:
The document does not explicitly state the numerical sample size for the test set used in the non-clinical studies. However, the study involved various technical tests (risk management, usability, software life cycle, basic safety, EMC, biocompatibility, accuracy, climatic, and ATS/ERS standards).
The data provenance is not explicitly stated as retrospective or prospective, but given the nature of the testing (device performance, safety, and function tests against standards), it would typically be prospective testing conducted as part of the device development and validation process. The manufacturer is Vyaire Medical, Inc. based in Germany, implying the tests were conducted or overseen by German entities.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
This information is not provided within the document. The ground truth for these non-clinical tests would typically be established by comparing the device's performance against recognized international standards (e.g., ISO, IEC, ATS/ERS). Therefore, the "experts" would be the technical committees and bodies responsible for defining these standards.
4. Adjudication method for the test set:
This information is not explicitly mentioned. For non-clinical validation studies against international performance standards, adjudication often involves documented verification and validation processes by the manufacturer and third-party testing labs, where results are compared against predefined criteria set by the standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, an effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was conducted or mentioned in this document. The device is a "Pulmonary-Function Data Calculator" and "Electrocardiograph," which perform measurements and analysis of lung function and ECGs, but there is no indication of AI assistance to human readers or interpretation within the scope of this submission. The device's ECG interpretation statements are explicitly mentioned as "partial qualitative information" and "no therapy or drugs can be administered based solely on the interpretation statements," implying human oversight is always required.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance evaluation was done for the device. The non-clinical tests assess the device's functional performance, safety, and accuracy (e.g., flow, volume, and ECG measurements) independently against established technical standards, without human interpretation in the loop influencing the measurement accuracy itself. The device is intended for use by trained healthcare professionals under the direction of a physician, who then reassesses the measurements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the non-clinical tests used for the Vyntus ONE device is based on established international and national standards and specifications. This includes:
- ISO 14971 (Risk Management)
- EN 62366 / IEC 60601-1-6 (Usability)
- ISO 62304 (Software Life Cycle)
- IEC 60601-1 (Basic Safety)
- IEC 60601-2 (EMC Compatibility)
- ISO 10993 (Biocompatibility)
- ATS/ERS Standardisation of Lung Function Testing
The performance characteristics (e.g., flow and volume accuracy/range/resolution) are also compared against the specifications defined by these standards, particularly the ATS/ERS standard.
8. The sample size for the training set:
This information is not applicable and not provided. The Vyntus ONE device is a medical device for measuring and analyzing physiological parameters, not an AI or machine learning model that requires a "training set" in the traditional sense for learning. Its functionality is based on established engineering principles and algorithms, validated against physical measurements and known standards.
9. How the ground truth for the training set was established:
This information is not applicable. As explained above, the device does not use a "training set" in the context of machine learning. Its internal algorithms and logic are developed and verified against known physical laws and validated measurement techniques, with performance assessed against established medical and engineering standards.
§ 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).