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The PowerCube+ Series is indicated for use in the measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume measurement, Body Plethysmography measurement, Lung Diffusion measurement, Occlusive Resistance measurement and Respiratory Muscle Strength measurement. The device provides information that aids in a diagnosis by a clinician.

The PowerCube+ Series is indicated for use by a clinician in a professional healthcare setting on adult and pediatric patients who are 5 years and older that can cooperate in the testing.

The GANSHORN PowerCube+ Series is a device that performs cooperation-dependent pulmonary function tests, including Spirometry, Body Plethysmography, Lung Diffusion measurement, Occlusive Resistance measurement and Respiratory Muscle Strength measurement. The device provides information that aids in a diagnosis by a clinician.

Spirometry is a set of non-invasive pulmonary function tests where the flow of inhaled/exhaled air is measured to determine physiological parameters such as Peak Expiratory Flow and Forced Vital Capacity. The patient's breathing flow is measured with ultrasound technology inside a breathing insert. Two ultrasound transducers measure the difference in ultrasound wave transit time to calculate breathing flow direction, speed, and volume.

Body Plethysmography provides for the measurement of physiological parameters such as Functional Residual Capacity and Specific Airway Resistance. The patient is seated in an air-tight chamber which has a fixed shape and volume. Pressure sensors measure the chamber pressure and the pressure close to the mouth, which is used as a proxy for alveolar pressure when measured under a zero-flow condition. Boyle's Law is used to infer the volume in the lungs from changes in chamber pressure.

Lung Diffusion testing is a non-invasive process for measuring diffusion capacity and lung volume. The patient inhales a test gas with known concentrations of helium and carbon monoxide. The patient's breath is held for 10 seconds during which time the helium dilutes into the lungs and the carbon monoxide diffuses through the alveoli into the blood. After 10 seconds of breath-hold time, the patient exhales and the difference between inhaled and exhaled gas concentrations is measured with a gas analyzer. The differences in gas concentration are used to determine physiological parameters such as DLCO (diffusing capacity of the lungs for carbon monoxide) and Alveolar Volume.

Occlusive Resistance measurement is an established method for measuring airway resistance during tidal breathing, using a shutter and mouth pressure sensor.

Respiratory Muscle Strength measurement is an established method for measuring the maximal strength of respiratory muscles, using a shutter and mouth pressure sensor.

The PowerCube+ Series has the following product model configurations:

• . PowerCube Body+ includes Spirometry and Body Plethysmography measurement
• . PowerCube Diffusion+ includes Spirometry and Lung Diffusion measurement
• . PowerCube Body+ / Diffusion+ includes Spirometry, Body Plethysmography, and Lung Diffusion measurement

All product model configurations support Occlusive Resistance measurement and Respiratory Muscle Strength measurement.

The PowerCube+ Series is mains-powered and not intended for mobile/transportable use.

The provided text focuses on the substantial equivalence of the GANSHORN PowerCube+ Series to predicate devices for regulatory clearance. It does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria in the format requested (i.e., a clinical study with human readers and AI).

The document outlines a series of bench tests to demonstrate performance in various modalities, but these are not structured as clinical studies with acceptance criteria for device performance parameters related to a "ground truth" established by experts in a diagnostic context. Instead, the performance testing focuses on compliance with international standards (e.g., ISO 23747, ISO 26782, ATS/ERS guidelines) and comparison against a calibrated flow/volume simulator or an FDA-cleared device.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical performance and AI integration, which are not detailed here.

However, I can provide what is available regarding performance testing and some related details:

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

The document mentions compliance with various standards and internal requirements, and comparative bench testing. Here's what can be extracted, focusing on quantitative performance where available:

Regarding the study that proves the device meets acceptance criteria:

The study referenced is a series of bench tests and comparative bench testing against an FDA-cleared device.

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

• Sample size for test set: Not explicitly stated in terms of number of patient cases. The "test set" for performance was described as using a "calibrated Hans-Rudolph flow/volume simulator at a range of physiological test points" and "simulated inhalation and exhalation with calibrated gas mixtures." For comparative testing with the predicate device, it mentions comparing measurements, but not a specific sample size of test points or patient data.
• Data provenance: Bench testing results and simulated data. No real-world patient data is mentioned for testing device performance against ground truth in a clinical context.

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

Not applicable. The ground truth for bench testing was established by calibrated instruments and simulators, not human experts.

4. Adjudication method for the test set

Not applicable, as ground truth was established by calibrated instruments, not human review requiring adjudication.

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. This document describes a medical device for measuring lung function parameters, not an AI-assisted diagnostic tool that involves human readers.

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

The device itself is a measurement system; its "performance" is its accuracy in providing these measurements. The document outlines standalone performance evaluations through bench testing to ensure the device accurately measures lung function parameters. There is no mention of a separate "algorithm only" performance study in the context of an AI-based diagnostic algorithm.

7. The type of ground truth used

For the performance testing, the ground truth was established by:

• Calibrated instruments and simulators (e.g., Hans-Rudolph flow/volume simulator, calibrated gas mixtures).
• Compliance with recognized international standards (e.g., ISO 23747, ISO 26782, ATS/ERS guidelines).
• Measurements from an FDA-cleared predicate device for comparative analysis.

8. The sample size for the training set

Not applicable. This is a medical measurement device, not an AI/machine learning model that requires a training set of data.

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

Not applicable, as there is no training set for an AI/machine learning model mentioned.

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The Model 9160 VitaloQUB is a whole-body plethysmograph device, when used with the Vitalograph Model 9100, is designed for lung function testing on adults and pediatrics, 6 years and older, by trained medical healthcare professionals in a variety of professional healthcare environments e.g., primary care, hospitals, and pharmaceutical research centers.

The proposed Model 9160 VitaloQUB incorporates the cleared Model 9100 (K221030) with integrated LCD display and ComPAS2 software (K213872).

The ComPAS2 software controls valves and reads unprocessed data from the sensors in the Model 9100 and from Model 9160. The ComPAS2 software then determines respiratory parameters including the 2 new parameters.

The ComPAS2 software is unchanged from K213872. The Model 9160 and Model 9100 firmware does not determine any respiratory parameters.

The Model 9160 is adding 2 additional parameters:

• TVG – Thoracic Gas Volume
• Raw Airway resistance

The provided text describes the regulatory clearance for the VitaloQUB Model 9160, a whole-body plethysmograph device. However, it does not contain specific details on the acceptance criteria or a dedicated study report that demonstrates the device explicitly meets numerical acceptance criteria. The text focuses on establishing substantial equivalence to predicate devices.

Here's an analysis based on the information available and what is missing:

The submission states that "Performance testing demonstrated that the subject device met its acceptance criteria," and then lists the types of testing performed. However, it does not provide the specific numerical acceptance criteria or the reported device performance for these criteria.

1. Table of acceptance criteria and the reported device performance:

Missing Information: For VTG and Raw, while the document states performance testing was done, the specific acceptance criteria and the results demonstrating compliance are not provided. The accuracy values listed in the table are copied directly from the "Subject Model 9160" column, indicating that these are the device's inherent specifications, and the comparison section implies they are similar to or meet expectations based on the predicate.

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

This information is not provided in the document. The text mentions "Bench testing" but does not detail the sample sizes for any of the performance tests, nor does it specify if any clinical data with human subjects (and thus data provenance) was used for direct performance evaluation of VTG and Raw measurements. The comparison tables focus on technological characteristics and principle of operation similarities to predicates.

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 in the document. The device outputs objective physiological measurements, rather than interpretations requiring expert consensus as ground truth. If clinical studies were performed for the new parameters (VTG, Raw), the method of establishing ground truth would depend on the study design. However, the document provided does not detail such clinical studies or the involvement of experts in establishing ground truth.

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

This information is not provided in the document. Given the nature of the device (measuring physiological parameters rather than rendering diagnoses or classifications), an adjudication method for a test set as described is unlikely to be directly applicable in the same way as for image-based diagnostic AI. If human subject studies were conducted to compare measurements, adjudication of patient conditions might be relevant, but this is not detailed.

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 is not applicable to this device. The VitaloQUB Model 9160 is a pulmonary function measurement device. It measures physiological parameters and does not involve "readers" or "AI assistance" in the diagnostic interpretation sense for which MRMC studies are typically performed. The device itself performs the measurements and calculations (via the ComPAS2 software), it does not assist human interpretation of complex data (like images) in a way that would be quantified by an MRMC study.

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

The device is inherently a standalone measurement system in terms of calculating the parameters. The ComPAS2 software, which is part of the system, outputs the respiratory parameters. This is the "algorithm only" performance. The document states: "The ComPAS2 software controls valves and reads unprocessed data from the sensors in the Model 9100 and from Model 9160. The ComPAS2 software then determines respiratory parameters...". The performance testing mentioned ("Bench testing", "ATS / ERS (2002, 2005, 2013, 2017 and 2019) Static condition") assesses the accuracy of these measurements directly from the device/software. Specific performance for VTG and Raw measurements would have been assessed in this standalone manner, but the numerical results are not provided.

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

For physiological measurement devices, the "ground truth" is typically established by physical standards, calibration gases, and established reference methods or simulated physiological conditions that adhere to recognized industry standards (e.g., ATS/ERS standards). The document mentions compliance with various ISO and ATS/ERS standards, which dictate the methods and accuracy requirements for such measurements. For example, gas concentrations for DLCO are compared against medical-grade gas mixes, and flow/volume against calibrated instruments.

8. The sample size for the training set:

This information is not provided. As the device is a measurement instrument incorporating software (ComPAS2) for calculations based on physical readings, it's not described as an AI/ML device that requires a "training set" in the conventional sense (e.g., for pattern recognition or classification). The software implements algorithms for physiological calculations rather than learning from data in a machine learning paradigm.

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

This information is not provided, and likely not applicable as the device is not described as an AI/ML system requiring a training set with ground truth in the context of machine learning. The algorithms are based on established physiological principles and equations.

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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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Ascent Cardiorespiratory Diagnostic Software 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 or a mask. The test can be viewed on-line with the help of a computer screen and can be printed after the test results can be saved for further referral or report generation purposes.

For use of the Bronchial Challenge option, the medical director of the laboratory, physician, or person appropriately trained to treat acute bronchoconstriction, including appropriate use of resuscitation equipment, must be close enough to respond quickly to an emergency.

The product can be utilized for patients from 4 years old and older as long as they can cooperate in the performance -- no special limit to patient's sex or height.

Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar settings.

In conjunction with pulmonary diagnostic hardware, Ascent software, a Windows desktop application developed using Microsoft's NET Framework, is used to collect data pertaining to the patient's degree of obstruction, lung volumes, and diffusing capacity. It is also used to present the collected lung diagnostic information so that it can be checked for quality and interpreted by a qualified physician, usually a pulmonologist.

The core purpose of the software is to facilitate pulmonary function testing in patients who may be suffering from pulmonary illnesses like Chronic Obstructive Pulmonary Disease and asthma. The software will interact with connected Medical Graphics Corporation diagnostic devices to perform the desired pulmonary function tests on the patient by a professional pulmonary function technologist. The application will display both actual and derived test variables to the user after a test is performed for purposes of data review.

Here's a breakdown of the acceptance criteria and study information for the Ascent Cardiorespiratory Diagnostic Software, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a typical quantitative pass/fail format within a table. Instead, it describes general validation and performance testing. However, we can infer the performance objectives and how they were met.

2. Sample Size for the Test Set and Data Provenance:

• Sample Size for Test Set: 38 test sessions.
• Data Provenance: The subjects for these test sessions were "from seven to sixty-three years old." The document does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. It mentions that the software presents data to a "qualified physician, usually a pulmonologist, for diagnostic interpretation," but this refers to the intended use, not the ground truth establishment for the validation study itself.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The "physiologic performance validation testing" implies direct measurement comparison rather than expert consensus on interpretive tasks.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not explicitly mentioned or described as being performed. The study focused on the performance of the software and integrated hardware, not on the impact of the software on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the "physiologic performance validation testing" and "software validation testing" described seem to represent a standalone assessment of the device's ability to measure and process pulmonary function parameters. The device's core function is data collection and analysis, which occurs without direct human interpretation assistance during the measurement phase. The overall intention is for a "qualified physician" to interpret the results generated by the algorithm.

7. The Type of Ground Truth Used:

The document doesn't explicitly state "ground truth" in the context of reference standards. However, the nature of the device (pulmonary function software) implies that the ground truth for "physiologic performance validation testing" would be the physical measurements obtained from the connected hardware devices for various pulmonary function parameters (e.g., airflow, volume, gas concentrations). The accuracy of these measurements would be compared against expected values or highly accurate reference standards, though these specific reference standards are not detailed in the provided text.

8. The Sample Size for the Training Set:

The document does not mention any training set sample size or details about a training set. This is likely because the device, as described, is not an AI/machine learning model that typically requires a discrete training phase with labeled data. It appears to be a software system for data acquisition, processing, and display based on established physiological algorithms and hardware interaction.

9. How the Ground Truth for the Training Set Was Established:

As no training set is discussed, there is no information on how its ground truth might have been established.

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The SentrySuite Product line 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 further referral or report generation purposes. Use of the Option Bronchial Challenge requires the supervision of a physician familiar with emergency medicine.

The products can be utilized for patients from 4 years on and older as long as they can cooperate in the performance - no special limit to patient's sex or height. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar settings.

The SentrySuite Product line when operating on the existing hardware for MasterScreen Pneumo, MasterScreen IOS, APS Pro and MasterScreen PFT will be as functional as the existing version of JLAB software for all the available measuring programs and options for these devices.

• The SentrySuite software replaces the JLAB software and got a brand-new graphical surface.
• Measurement can be accomplished under SentrySuite software equivalent as it was possible under the previously powerful JLAB software
• The results of the tests can be viewed on-line on the computer screen during the test and can be saved on the computer hard disk for further referral or report generation purposes.
• SentrySuite provides the functionality currently available on the MasterScreen devices using the JLAB software.
• SentrySuite can be operated on workstations and on servers.

Measurements:

• Spiormetry
• Flow Volume
• Maximal Voluntary Ventilation (MVV)
• Incentive Spirometry
• R-Occlusion
• Impulse oscillometry
• Bronchial test
• FRC Helium Rebreathing
• Real Time Single Breath Diffusion
• Intra Breath Diffusion
• Bodyplethysmography
• Respiratory Drive P0.1
• PI/PE Max (MIP/MEP)
• Single Breath Diffusion CO/He

The acceptance criteria for the SentrySuite Product Line, specifically for the updated SentrySuite 2.7 software, are based on the statistical correlation of its performance with the predicate JLAB software. The study's objective was to demonstrate substantial equivalence by showing that the new software generates results that are highly correlated with the predicate software.

Here's a breakdown of the requested information:

Acceptance Criteria and Reported Device Performance:

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The Masterscreen PFT Body is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume/Resistance measurements, lung diffusion measurements and bodyplethysmography measurement. The device provides data / information and supports help for a diagnosis.

MasterScreen PFT (Clinical Trial version) includes Spirometry/Flow-Volume/Resistance measurements and lung diffusion measurements with individual access rights defined for different user roles (e.g. Investigator, doctor, study nurse, trainer and service personnel).

MasterScreen PFT includes Spirometry/Flow-Volume/Resistance and lung diffusion measurements.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. It is a 510(k) premarket notification letter from the FDA to VIASYS Healthcare GmbH concerning their MasterScreen PFT devices. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.

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The Body Box 5500 when used in conjunction with a computer and the ComPAS pulmonary function software is intended to perform plethysmography, diffusion and spirometry to provide pulmonary function testing in adult and pediatric patients.

Not Found

This document is a 510(k) clearance letter from the FDA for the "Body Box 5500" device. It does not contain the specific information needed to answer the request about acceptance criteria and a study proving a device meets them. The letter confirms substantial equivalence to a predicate device but does not detail performance metrics, study design, or results.

Therefore, I cannot provide the requested information based on the provided text.

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