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The Vyntus BODY is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece, a mask or nasal adapters. The results of the test can be viewed online with the help of a computer screen and can be printed after the test. 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 BODY measurements. An interpretation by SentrySuite is only significant if it is considered in connection with other clinical findings.

The Vyntus BODY is a whole-bodyplethysmograph and consists of the Vyntus BODY cabin, an ultrasonic flow sensor (USS), and a shutter. The Vyntus BODY system allows the determination of a subjects' pulmonary function status. It includes the determination of the subjects' ventilatory flows and volume by means of the USS. The measurement of the lung diffusion by the DLCO technique is accomplished with the supply of test gas and the gas analyzers for methane (CH4) and carbone monoxide (CO).

All variants are stationary and not battery operated. The sensor data is sent to a host computer system via cable connection for processing, storage, and reporting. The host computer can be networked via LAN, WLAN, or Internet.

All measurements are performed with the use of the Windows based operating software SentrySuite (SeS). The SeS software also stores the measurement results and provides output capabilities.

The host computer, monitor, and printer are mounted on the Vyntus Cart. Use of the cart is optional; computing equipment may be placed on other furniture.

The provided text is a 510(k) summary for the Vyntus BODY, a pulmonary-function data calculator. It outlines the device's characteristics, its comparison to predicate devices, and the performance data submitted to support its substantial equivalence. However, it does not contain a detailed study report that proves the device meets specific acceptance criteria with reported device performance metrics and specific sample sizes for test sets.

The document focuses on demonstrating substantial equivalence to predicate devices, rather than an independent performance study against predefined criteria.

Therefore, many of the requested details about acceptance criteria, reported performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not explicitly provided in this document.

Here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance:

The document mentions "Accuracy testing" as one of the performance data provided. In the "Patient User Interface Specifications" table (Page 7-8), it lists performance specifications for flow and volume accuracy which can be considered acceptance criteria. However, it does not explicitly provide the reported device performance against these criteria in a clear table format. The table below presents the acceptance criteria as listed:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample size for the test set: Not mentioned.
• Data provenance: Not mentioned. The document primarily refers to "Accuracy testing" as a type of performance data provided, but without details on the studies or datasets used for this testing.

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):

This information is not provided. The device is a "Pulmonary-function data calculator," suggesting that its accuracy would likely be evaluated against established physiological measurement standards, not necessarily against expert human interpretation in the same way an AI diagnostic imaging tool would be.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable or not mentioned. The device's primary function is to measure and calculate lung function parameters; its performance would likely be validated against metrological standards or established calibration methods, rather than through an adjudication process of expert interpretations.

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:

Not applicable. The Vyntus BODY is a pulmonary function data calculator, not an AI-assisted diagnostic tool that aids human readers in interpreting complex medical images or data. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function or validation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself is a standalone system for measurements, data collection, and analysis. It is designed to perform these functions "without human-in-the-loop performance" in terms of its direct measurement and calculation capabilities. The document states, "A qualified physician has to reassess all Vyntus BODY measurements. An interpretation by SentrySuite is only significant if it is considered in connection with other clinical findings." This indicates that while the device performs its analytical function standalone, ultimate clinical interpretation requires a physician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "Accuracy testing" mentioned would typically use calibrated instruments or known physical standards as ground truth for flow and volume measurements. The document references "ATS/ERS Task Force: Standardization of Lung Function Testing," implying that the device's performance is likely measured against these established international standards for pulmonary function testing.

8. The sample size for the training set:

Not applicable or not mentioned. The device appears to be a measurement and calculation system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its functionality is based on known physiological principles and instrumentation, likely calibrated against standard references.

9. How the ground truth for the training set was established:

Not applicable, as there's no indication of a "training set" for an AI/ML algorithm.

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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:

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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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. 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).

The Vyntus CPX system is an accurate and reliable system that allows the determination of a subjects' metabolic response while exercising. It is a stationary, mains powered ergospirometry system. The system records the data breath-by-breath. The breath-by-breath data is collected through a facemask or mouth-piece and is sent to a host computer system via cable connection. The digital volume transducer (DVT) measures the gas volume in- and expired. Gas samples are continuously drawn from a location very close to the mouth (between DVT and the face-mask or mouth-piece). The gas samples are dryed by Nafion tubes and analyzed for O2 and CO2 content. From the breathing volume and the differences between inspiratory and expiratory O2 and CO2 concentrations the oxygen uptake and the CO2 production (V'O2 and V'CO2) are calculated by the software. The workload protocol selected by the user will control the ergometer device accordingly and the changes in the above vital signs due to the change in workload are recorded. All data is stored together with the patient and test data in the database for later evaluation and printing.

The provided document is a 510(k) Summary for the Vyntus/SentrySuite product line, a pulmonary-function data calculator. This type of document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than providing a detailed study report of accuracy relative to a specific ground truth.

Therefore, many of the typical acceptance criteria and study details for AI/device performance metrics (like sample size for training/test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance of an algorithm, or specific types of ground truth like pathology) are not applicable or not explicitly stated in this document.

However, based on the information provided, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria are implied by the "Accuracy" column for each parameter, representing the desired performance. The reported device performance is presented as meeting these desired accuracies.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: The document does not specify a sample size for the accuracy testing. It refers to "Measurement effectiveness & accuracy according golden standard 'Douglas bag'" which indicates the method of testing, but not the number of tests or subjects.
• Data Provenance: Not specified. The company (CareFusion Germany 234 GmbH) is based in Germany, suggesting testing might have been done there. The testing is non-clinical bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable. The ground truth for the performance parameters (like O2 uptake, CO2 output, flow, volume) is established through a "golden standard 'Douglas bag'" and other calibrated measurement techniques, not expert review of images or data.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. This device measures physiological parameters, and accuracy is determined by comparison to a "golden standard" reference, not through human adjudication of differing interpretations.

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:

• MRMC Study: No, an MRMC study was not done. This device is a measurement system, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Yes, the accuracy testing described in the tables (Ergospirometry and Volume Sensor parameters) represents the standalone performance of the device's measurement capabilities. The device's software calculates these parameters.
  • The "Summary Discussion of Bench Performance Data" states: "The CareFusion Vyntus CPX cardio pulmonary exercise system passed all specified test requirements. The validation and verification testing confirmed this device meets user needs and design inputs for a CPET system. Testing also confirmed physical attributes and device performance meet the requirements of the standards listed in the performance testing summary above."
  • This confirms the device, including its algorithms, performs according to the specified accuracies.

7. The type of ground truth used:

• Type of Ground Truth: The ground truth for the accuracy testing was established using a "golden standard 'Douglas bag'" method for measurement effectiveness and accuracy. This refers to a highly accurate reference method for collecting and analyzing breathed gases. Other parameters (volume, flow) would be compared against calibrated reference instruments.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable/not stated. This document describes a medical device for measuring physiological parameters, whose core functionality relies on physical sensors and established scientific principles for calculation. It is not an AI/Machine Learning model that typically requires a discrete training set in the way a diagnostic AI would. The "software life cycle" according to ISO 62304 is mentioned, implying robust software development and verification, but not a "training set" in the context of data-driven AI.

9. How the ground truth for the training set was established:

• Ground Truth for Training Set: Not applicable. As explained above, the concept of a "training set" and its associated ground truth establishment is not typically relevant in the context of this type of device's regulatory submission where the focus is on sensor accuracy and calculation validity against known physical standards.

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