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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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