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510(k) Data Aggregation
(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.
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(30 days)
The GEM is intended to be used for diagnostic use in the treatment of pulmonary illnesses with an intended use and indication for use as a configurable, non-invasive pulmonary function tester (PFT) testing system.. The GEM is indicated for use in: pulmonary function testing.
The Collins GEM (Gas Exchange Module) is a Pulmonary Function Test System. is intended as a configurable, non-invasive pulmonary function tester (PFT). These tests are suitable for both pediatric and adult patient testing. Compatible with the Collins' Body Plethysmograph as an optional module.
The GEM (Gas Exchange Module) is a configurable, non-invasive pulmonary function tester (PFT) testing system. It includes a spirometer (pneumotach), gas analyzers (infrared for CO, CO2, CH4 and electrochemical for O2), and associated electronics.
The Collins GEM (Gas Exchange Module) is a diagnostic spirometer intended for use in pulmonary function testing.
Here is a summary of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Parameter | Acceptance Criteria (Standard/Reference) | Reported Device Performance |
|---|---|---|
| Spirometer Metrics | ||
| Resistance (Pneumotach) |
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(96 days)
The VentNet system consists of a PC based Central Monitoring Station and either a hardwire or wireless communication means allowing the remote monitoring of up to 24 continuous mechanical ventilators. VentNet further has a means of communication via paging system for the remote notification of alarms or changes in ventilator status. The VentNet automatically records ventifator setting changes and alarm events with patient physiological data from the monitored ventilators. The user may then review this information in a ventilator flowsheet format or print it as pre-formatted reports.
VentNet's intended use is to supplement the operation of dispersed or remotely located mechanical ventilators. VentNet allows the remote monitoring of multiple ventilators from a central station. VentNet displays ventilator settings, ventilator alarm status and physiological patient information as communicated from the monitored mechanical ventilator. VentNet also includes an optional feature which causes automatic notification, via paging system to defined users of certain ventilator alarms. VentNet is not intended to replace on-hand competent medical staff in monitoring for, or responding to ventilator alarms but is intended to support that staff by notifying other respiratory care staff or ventilator specialists in the event of certain alarm conditions.
VentNet's secondary intended use is the automation of some of the record keeping and reporting functions performed during mechanical ventilation.
The VentNet system consists of a PC based Central Monitoring Station and either a hardwire or wireless communication means allowing the remote monitoring of up to 24 continuous mechanical ventilators. VentNet further has a means of communication via paging system for the remote notification of alarms or changes in ventilator status. The VentNet automatically records ventifator setting changes and alarm events with patient physiological data from the monitored ventilators. The user may then review this information in a ventilator flowsheet format or print it as pre-formatted reports.
The provided document is a 510(k) Premarket Notification summary for the VentNet Central Monitoring Station. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a clinical study is not available within this document. The document primarily describes the device's technical specifications and compares them to predicate devices to establish substantial equivalence based on non-clinical performance data.
Here's an analysis of the information that is available, based on the prompt's request:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly present a "table of acceptance criteria and reported device performance" in the way a clinical study would for an AI/medical device. Instead, it lists "Product and Technical Specifications" and "Device Claims" which implicitly serve as performance goals, and then leverages a comparison matrix to predicate devices to argue equivalence. No quantitative "reported device performance" against these specifications from a formal study is detailed.
However, we can infer some "acceptance criteria" from the "Device Claims" and "Product and Technical Specifications" sections. The "reported device performance" is then implicitly demonstrated by stating these specifications and implying they are met, as part of the overall argument for substantial equivalence via non-clinical testing.
| Acceptance Criteria (Inferred from Claims/Specifications) | Reported Device Performance (As stated in the document) |
|---|---|
| Monitoring Capacity (Wireless) | Up to 24 continuous mechanical ventilators |
| Monitoring Capacity (Hardwire) | Up to 16 continuous mechanical ventilators |
| Remote Monitoring Features | Displays ventilator settings, alarm status, and physiological patient information |
| User Interface | Uses graphical user interface conventions, compatible with mouse or touchscreen for ease of learning and operation |
| Ventilator Compatibility | Compatible with Nellcor Puritan-Bennett 7200 Series Ventilator (host port or DCI) and future compatible ventilators |
| Automatic Record Keeping | Automatically records ventilator settings and alarm events (up to 1000 records) with time and date stamps; records physiological patient information with alarm events. |
| Reporting Features | Predefined report formats; archiving data; exporting data to third-party information systems. |
| Alarm Status Display | Color-coded software buttons for each ventilator, with labels for patient ID and location; ability to investigate specific active alarm codes. |
| Paging System Integration | Optional configuration with paging systems for remote notification of certain alarm conditions; user-definable alarm message paths and notification conditions (primary/secondary message paths, individual ventilator/alarm conditions). |
| Security | Passcode protection to restrict access to functions that interrupt monitoring or cause data loss. |
| Central Station Electrical | 115 Vac, 60 Hz, 5 A (maximum) or 230 Vac, 50 Hz, 2.6 A (maximum) |
| Remote Radio Transceiver Defibrillation Protection | Not damaged by defibrillation, returns to normal operation within 15 seconds. |
| Computer Hardware | Pentium-100 MHz, 16 MB RAM, 1 GB Hard Drive, 3.5-inch Floppy Drive, Hercules Dynamite Video Board, Serial Mouse, 101-key Keyboard |
| Monitor Specifications | 15 inch or 17 inch diagonal screen, Touchscreen hardware installed, 800 x 600 pixel resolution, 256 colors |
| Operating Temperature | +10° C to +35° C (+50° F to +95° F) |
| Operating Relative Humidity | 30% RH to 80% RH (noncondensing) |
| Radio Transceiver Frequencies | Central Transceiver: 902-928 MHz; Remote Transceiver: 902-928 MHz |
| Radio Transceiver Output Power | Central Transceiver: +20 dBm (100 mW) minimum; Remote Transceiver: +15 dBm nominal, ±2.0 dB |
| Radio Transceiver FCC Compliance | Spectrum Usage: Spread spectrum (IAW FCC Par. 15.247) |
| Printer Compatibility | HPGL/2 and PCL5 compatible, minimum 2 MB printer memory. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The document describes "non-clinical performance data review" based on testing for EMI, software verification/validation, environmental testing, and stress testing. This implies technical testing, not a study with a patient "test set."
- Data Provenance: Not applicable for a clinical test set. The data provenance mentioned is related to engineering and software testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a test set with an associated ground truth established by experts. The device's function is data presentation and alarm relay, not diagnostic interpretation.
4. Adjudication method for the test set:
- Not applicable. No clinical 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:
- No. This is not an AI diagnostic device. It's a central monitoring station for ventilators. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies standalone system performance was evaluated through "software verification and validation of both the system software performance as well as the operating system software performance, environmental testing and stress testing both at the integration level and the system level." However, this refers to the system's technical functionality, not a standalone diagnostic algorithm's performance. The device is explicitly designed to support human staff, not replace them.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The performance data reviewed involved validation of technical specifications and software functionality, not clinical diagnostic accuracy against a ground truth.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning device that would require a "training set" for model development.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set is relevant for this type of device.
Study Proving Acceptance Criteria:
The document states: "The determination of substantial equivalence was based on an assessment of nonclinical performance data. The data includes testing for EMI compatibility and susceptability, software verification and validation of both the system software performance as well as the operating system software performance, environmental testing and stress testing both at the integration level and the system level. The conclusion drawn from a review of the data indicates that the VentNet is substantially equivalent to the predicate devices."
This statement indicates that the "study" proving the device meets its (implicitly stated) performance criteria and is "substantially equivalent" involved:
- EMI Compatibility and Susceptibility Testing: To ensure the device operates correctly in its intended electromagnetic environment without interference and is not unduly affected by external electromagnetic sources.
- Software Verification and Validation: To confirm that the software performs as designed and meets all specified technical and functional requirements. This would involve unit testing, integration testing, system testing, and potentially user acceptance testing.
- Environmental Testing: To ensure the device can withstand specified operating and storage conditions (temperature, humidity, etc.).
- Stress Testing: To evaluate the system's robustness and stability under extreme or heavy load conditions.
- Integration and System Level Testing: To confirm that all components work together correctly as a complete system.
This approach demonstrates meeting technical specifications and equivalency to predicate devices, rather than a clinical performance study with patient data and a diagnostic ground truth.
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