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The STS device is intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS device is to be used by either a physician, respiratory therapist, or technician. The STS device is intended to be used in a professional healthcare environment.

The STS is a handheld spirometer intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS is to be used by either a physician, respiratory therapist, or technician. The STS device is pulmonary function testing device that measures both flow/volume (spirometry), lung volume and resistance/compliance parameters. It is a multi-use device that should be used with a compatible single-use, disposable mouthpiece which incorporates a viralbacterial filter protecting the patient from the internal components of the device is battery operated allowing for approximately 40 operating hours between charges. The measurement results, which are transmitted via Bluetooth, are displayed on the physician's computer via the STS software/App.

The provided text is a 510(k) summary for the STS device, a pulmonary function data calculator. While it mentions a clinical study, the details provided are limited and do not fully address all requested points regarding acceptance criteria and study specifics for proving the device meets those criteria.

Based on the provided document, here's what can be extracted and what remains unknown:

1. Table of acceptance criteria and reported device performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria values for performance. However, an implicit acceptance criterion is a "high correlation" and specific statistical thresholds mentioned in the clinical study summary.

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

• Sample Size: 161 subjects (61 females, 100 males, implicitly). This test set was used for the clinical study comparing STS to Body Plethysmography.
• Data Provenance: Not explicitly stated (e.g., country of origin). It is a prospective study as subjects were "enrolled" and "tested by both STS and BP," suggesting data was collected specifically for this study.

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

• The document states that Body Plethysmography (BP) is considered the "gold standard" for measuring lung volumes. Therefore, the BP measurements served as the ground truth.
• It does not specify the number of experts or their qualifications involved in performing or interpreting the Body Plethysmography tests. It's implied that standard clinical practice for BP was followed, which would involve trained medical professionals, but this is not detailed.

4. Adjudication method for the test set:

• No information on adjudication methods is provided. The comparison is directly between the STS device measurements and the "gold standard" Body Plethysmography measurements.

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or reported. This device is a pulmonary function data calculator and not an AI-assisted diagnostic imaging tool where human reader performance with and without AI assistance would typically be evaluated. The study focuses on the device's accuracy in measuring physiological parameters when compared to a gold standard.

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

• The clinical study described evaluates the "performance of STS technique in calculating resistance and compliance parameters" by comparing it with Body Plethysmography.
• The STS device itself is a "pulmonary function testing device that measures both flow/volume (spirometry), lung volume and resistance/compliance parameters." This implies a standalone performance evaluation of the device's measurements against the gold standard. However, the device "is to be used by either a physician, respiratory therapist, or technician" and its results are "displayed on the physician's computer via the STS software/App," indicating there's a human-in-the-loop for operation and interpretation. The study evaluates the measurement accuracy, which can be seen as a form of standalone performance for the measurement part of the device.

7. The type of ground truth used:

• The ground truth used was "gold standard" Body Plethysmography (BP) measurements of lung volumes. While BP is a clinical measurement, it serves as the established reference standard in this context.

8. The sample size for the training set:

• The document does not provide any information about the sample size used for the training set. This is a 510(k) submission, and often, proprietary training data details are not included in the public summary.

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

• The document does not provide any information on how the ground truth for the training set was established, as details about the training set itself are absent.

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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 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).

A qualified physician has to reassess all Vyntus/SentrySuite measurements. An interpretation by Vyntus/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 ECC 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.

Option Hi/Lo FiO2: The High/low FiO2 option of the Vyntus CPX is designed to measure the ventilation and the gas exchange (02 uptake, CO2 production) of a subject with varying inspiratory concentrations of O2.

This document primarily details a 510(k) premarket notification for the Vyntus/SentrySuite Product Line, specifically focusing on the addition of an option for High/Low FiO2. The submission aims to demonstrate substantial equivalence to previously cleared devices.

Here's an analysis of the provided text with respect to your requested information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a numerical or target performance metric for each characteristic. Instead, it refers to passing "applicable tests and standards" and meeting "user needs and design inputs." The performance data section focuses on demonstrating the device meets the technical specifications and accuracy of its predecessors.

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

The document primarily describes bench performance data and compliance with standards. It does not mention a specific "test set" in terms of patient data or a clinical study for the new High/Low FiO2 option. The testing appears to be centered on engineering and regulatory compliance rather than clinical performance data from a patient sample. Therefore, there is no information provided regarding sample size, country of origin, or retrospective/prospective nature of data for a clinical test set.

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)

Given that clinical testing was not performed (stated explicitly), there is no information about experts used to establish ground truth for a clinical test set. The performance data is based on engineering tests against established technical specifications for pulmonary function devices.

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

As no clinical test set is described, there is no information on an adjudication method for a 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

This submission is for a pulmonary function and cardio-pulmonary exercise testing device, not an AI-assisted diagnostic or interpretive system in the context of "human readers." While the Vyntus ECG component does offer automatic analysis and "suggestions for the interpretation," the document states these are "partial qualitative information" and "no therapy or drugs can be administered based solely on the interpretation statements." Furthermore, for the new option, no MRMC comparative effectiveness study is mentioned, nor is any AI assistance or effect size on human readers discussed.

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

While the device includes software with automated analysis for ECG, the focus of this submission is on the added High/Low FiO2 option for the CPX system and the overall compliance of the product line. No specific standalone performance study of an algorithm independent of the device's measurement capabilities is detailed. The performance testing section refers to "Accuracy Testing" as a general item but does not specify a standalone algorithm performance study.

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

For the technical performance tests discussed (flow, volume, ventilation accuracy), the ground truth would typically be established by reference standards or highly accurate calibration devices that measure these physical parameters precisely. The document refers to "applicable tests and standards" for accuracy testing. For the non-clinical tests (safety, EMC, risk management, usability, software life cycle, biocompatibility), the ground truth is simply compliance with the respective international standards (e.g., IEC 60601-1, ISO 14971). There is no mention of ground truth based on expert consensus, pathology, or outcomes data, as clinical testing was not performed for this submission.

8. The sample size for the training set

The document states, "Clinical testing was not performed with this device." Therefore, there is no information on a training set or its sample size as no clinical data appears to have been used for an algorithm development for this specific submission's context.

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

As no clinical training set is mentioned, there is no information provided on how ground truth for a training set was established.

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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.

Ask a specific question about this device

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 COSMED K5 Wearable Metabolic Technology is a device designed to measure cardio-respiratory and metabolic functions during stress testing, rehabilitation, sports medicine and other related activities, performed in professional healthcare facilities only. The system is not intended for Home Use.

The main measurements reported by the system are Oxygen Uptake production, Ventilation, Heart Rate and Energy Expenditure.

K5 is intended to use with adults and children over the age of 14 years.

It is to be used by physicians or by trained personnel on a physician responsibility.

The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It must not be intended as a monitoring device, nor as a sole means for determining a patient's diagnosis but for the purpose of assisting the clinician in the diagnosis of cardio-pulmonary diseases

The COSMED K5 Wearable Metabolic Technology is a portable unit, designed for the measurement of resting and exercise metabolism in the laboratory, utilizing international measurement quidelines published by relevant scientific societies. The K5 consists of the following main parts:

• Main portable unit
• Optional Bluetooth receiver
• PC software
• Face mask with head cap
• Turbine flowmeter with optoelectronic reader and wind cover
• Harness
• Heart rate monitor belt
• 02 sensor
• Battery charger + batteries
• AC/DC adapter
• USB cable
• Carrying case
• Optional pressure regulator for calibration

The K5 system is intended to be used the laboratory, by either direct connection or by telemetry. The system offers both 'breath-by-breath' and 'mixing chamber' operational modes.

Here's an analysis of the acceptance criteria and study information for the COSMED K5 Wearable Metabolic Technology, based on the provided FDA 510(k) summary:

Note: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report. Therefore, some of the requested information, particularly regarding specific study details like training set provenance, expert qualifications, and detailed statistical methodologies for clinical trials, is not fully elaborated in this type of document.

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Accuracy validation (Vt, RF, VO2, VCO2)" as a non-clinical test. The table on page 7 provides specific measurement accuracies for ventilation, VO2, and VCO2, which serve as the acceptance criteria and reported performance.

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The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients, 5 years and older, while at rest (including spirometry, lung volumes and diffusing capacity). The PulmOne MiniBox+ is to be used by a physician, respiratory therapist, or technician in a hospital or clinic setting

The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients while at rest (including spirometry, lung volumes and diffusing capacity). The PulmOne MiniBox+ is to be used by either a physician, respiratory therapist, or technician. A cleared single-use, disposable viral-bacterial filter separates the patient from the internal components of the device.

The MiniBox+ measures all common spirometric measurements as well as relative and absolute lung volumes and diffusing capacity.

The MiniBox+ is equipped with a diffusing capacity module which is embedded into the MiniBox+ enclosure and located in the upper end of the device. This feature allows easy measurement of the volumes and concentrations (CO and CH4) of inspired and expired breath, of the test gas mixture and patient sample respectively, making possible the calculation of the diffusion capacity [DLco]. MiniBox + DLco [diffusing capacity factor of the lung for carbon monoxide (CO)] module uses the single breath concept and enables the measurements by setting and controlling the maneuver stages as defined in ATS/ETS DLco guidelines.

Here's a breakdown of the acceptance criteria and study information for the PulmOne MiniBox+ device, based on the provided document:

Acceptance Criteria and Device Performance

The document describes the performance and technical specifications of the MiniBox+ and compares them to predicate devices. The MiniBox+ is a pulmonary function data calculator, and its performance is evaluated against established standards for spirometry, lung volumes, and diffusing capacity measurements.

Table of Acceptance Criteria and Reported Device Performance

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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 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).

A qualified physician has to reassess all Vyntus/SentrySuite measurements. An interpretation by Vyntus/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 ECC 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 ECG is the perfect 12-Lead PC-ECG extension for the Vyntus CPX via secure Bluetooth® communication. One integrated solution through the SentrySuite platform helps laboratories ease procedures and integration to reduce costs.

The Vyntus ECG records the full 12-lead resting and stress ECG via its wireless, battery operated ECG amplifier. The evaluation and interpretation is using the proven Hannover ECG System (HES).

Scientific Concept:
The surface electrodes of the Vyntus ECG record the electrical signals that are mainly generated by the heart muscle activity and repolarization. The small voltages are amplified and A/D converted. A low frequency high-pass filter is applied and the recorded signals are transmitted to the PC for recording, storing, evaluation, interpretation, display and reporting.

Significant performance characteristics:

• Full 12 lead ECG
• Small, low weight (

The provided text is a 510(k) Pre-Market Notification for the CareFusion Vyntus/SentrySuite Product Line, specifically for the Vyntus ECG component. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria in a detailed clinical study.

Therefore, the input document does not contain the detailed information required to fully answer the request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance for specific clinical metrics. The "Summary Table of Comparison" compares technological characteristics with predicate devices, not performance against acceptance criteria.
• Details on sample size, data provenance, number of experts, adjudication methods, or ground truth for a test set.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Details on the training set size or how its ground truth was established.

The document states: "Clinical testing was not performed with this device." This explicitly means there isn't a clinical study proving the device meets acceptance criteria in a real-world patient setting.

However, the document does list non-clinical tests and standards the device passed to demonstrate substantial equivalence, which can be interpreted as fulfilling certain "acceptance criteria" related to safety and technical performance.

Here's an attempt to answer based on the available (albeit limited for the specific request) information in the document, focusing on the non-clinical tests as proxies for "acceptance criteria" in the context of this 510(k) submission:

1. Table of acceptance criteria and the reported device performance

Based on the "Summary of Device Testing" section, the acceptance criteria are adherence to specified international standards, and the reported performance is that the device passed these applicable tests.

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

The document explicitly states: "Clinical testing was not performed with this device." Therefore, there is no clinical test set of patients, data provenance, or sample size described for evaluating clinical performance against acceptance criteria. The non-clinical tests are against the device itself and its components.

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

Not applicable. As no clinical testing was performed, there was no clinical test set requiring ground truth established by experts.

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

Not applicable. As no clinical testing was performed, there was no clinical test set 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

No MRMC study was mentioned or performed, as "clinical testing was not performed with this device." The device provides "suggestions for the interpretation" but the document states, "A qualified physician has to reassess all Vyntus/SentrySuite measurements. An interpretation by Vyntus/SentrySuite is only significant if it is considered in connection with other clinical findings." This implies the device is an aid, but no study on human improvement with this aid was presented.

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

The document mentions that the Vyntus ECG uses the "proven Hannover ECG System (HES)" for evaluation and interpretation. It states, "12-lead ECGs are analyzed automatically and suggestions for the interpretation of the resting ECG can be made by the software." This indicates a standalone algorithm for interpretation. However, the document does not provide performance metrics (e.g., sensitivity, specificity) for this standalone algorithm against a ground truth dataset. It only confirms the algorithm is incorporated.

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

For the non-clinical tests (ISO, EN, IEC standards), the "ground truth" is adherence to the definitions and requirements specified within those objective technical and safety standards. For the built-in Hannover ECG System (HES) algorithm, the document does not specify how its internal ground truth was established or validated for its interpretation capabilities as part of this submission.

8. The sample size for the training set

Not applicable to this 510(k) submission. The document identifies the integrated "Hannover ECG System (HES)" as the evaluation and interpretation algorithm. The training set size for the development of HES itself is not provided in this regulatory document.

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

Not applicable to this 510(k) submission. The method for establishing ground truth for the training set of the "Hannover ECG System (HES)" is not described in this regulatory document.

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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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The PulmOne MiniBoxPFT is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBoxPFT is to be used by either a physician, respiratory therapist, or technician.

The MiniBoxPFT™ is a table-top pulmonary function testing (PFT) device that measures both spirometry and lung volumes. It is developed and manufactured by PulmOne Advanced Medical Devices, Ltd. The MiniBoxPFT™ is composed of two modules: an OEM 510(k) cleared Spirometry module and a Lung Volume Measurement (LVM) module. A single-use, disposable viral-bacterial filter separates the patient from the internal components of the modules.

The PulmOne MiniBoxPFT is a pulmonary function testing (PFT) device that measures spirometry and lung volumes. The pivotal study aimed to demonstrate that the Total Lung Capacity (TLC) measured by the device's Lung Volume Measurement (LVM) module is substantially equivalent to the TLC measured by the ZAN 500 Plethysmograph (predicate device).

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "pre-defined success criterion was established from scientific literature that reported on the accuracy of FDA-cleared devices that measure TLC and compared these devices to TLC measured with body plethysmography." However, the specific numerical acceptance criteria (e.g., a specific percentage agreement or correlation coefficient) and the exact reported performance metrics (beyond "successfully met its primary success criterion for accuracy" and "no erroneous results") are not explicitly detailed in the provided text.

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

• Sample Size: The document does not specify the exact sample size for the pivotal study. It states that the study "randomized subjects (healthy and non-healthy) of varying age, sex, and race."
• Data Provenance: The study was "multi-centered," implying data was collected from multiple locations. The country of origin of the data is not specified. The study was prospective as subjects were measured on both the proposed device and the predicate device within the context of the study.

3. Number of Experts and Qualifications for Ground Truth:

This information is not provided in the document. The ground truth for the test set was the TLC measurements from the predicate device (ZAN 500 Plethysmograph).

4. Adjudication Method:

The document does not describe an adjudication method for the test set. The comparison was directly between the MiniBoxPFT™ and the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This study focuses on the agreement between the new device and a predicate device for measuring physiological parameters, not on the improvement of human readers with AI assistance.

6. Standalone Performance Study:

Yes, a standalone study (algorithm only without human-in-the-loop performance) was performed. The pivotal study directly evaluated the MiniBoxPFT™'s ability to measure TLC by comparing its results to a predicate device. This is a standalone evaluation of the device's core function.

7. Type of Ground Truth Used:

The ground truth used for the pivotal study was the Total Lung Capacity (TLC) measurements obtained from the ZAN 500 Plethysmograph, which is the predicate device. This represents a reference standard for TLC measurement.

8. Sample Size for the Training Set:

A "feasibility study was conducted to determine the ability of the device to measure TLC and to develop the algorithm for measuring TLC." However, the sample size for this training set is not provided.

9. How Ground Truth for Training Set was Established:

The document states that the feasibility study was used "to develop the algorithm for measuring TLC." It implies that data collected during this feasibility study was used to train or refine the algorithm. However, it does not explicitly detail how the "ground truth" for this training data was established within the feasibility study (e.g., whether it was also compared to a reference standard like plethysmography, or if it was based on expert-defined physiological parameters).

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The LCI Option for Innocor is intended to measure the Lung Clearance Index (LCI), which is the cumulative expired volume required to clear an inert gas from the lungs during normal breathing in a multiple-breath washout (MBW) test divided by the Functional Residual Capacity (FRC).

Innocor is a compact point-of-care device intended to be used for non-invasive measurement of a) cardiac output (CO) and other hemodynamic parameters utilizing inert gas rebreathing (IGR) technology, b) metabolic parameters including oxygen uptake by means of a breath-by-breath gas exchange method, c) spirometry parameters by means of forced respiratory maneuvers, and d) peripheral airway function by means of multiple-breath inert gas washout.

The basic Innocor provides cardiac output (CO) as the principal measured parameter. Utilizing inert gas rebreathing, Innocor measures the relative levels of two inhaled gases of differing blood solubility over approximately 3-4 respirations. The disappearance curve for the blood soluble gas is used to calculate pulmonary blood flow (PBF), which in the absence of a significant intrapulmonary shunt is equal to cardiac output. The functional residual capacity (FRC) is determined from the dilution of the relatively insoluble gas during the same maneuver.

The LCI Option for Innocor, used alone or in conjunction with the entire Innocor system, provides information on lung volume and peripheral airway function.

The LCI is calculated as the cumulative expired volume (VcE) required to clear the inert tracer gas from the lungs during normal breathing, minus the product of the number of wash-out breaths and the external dead space outside the lips. divided by the subject's Functional Residual Capacity (FRC). FRC is the amount of air that stays in the lungs (up to the lips) after a normal expiration. In other words, LCI represents the number of lung volume turnovers (i.e. FRCs) that the subject must breathe to clear the inert tracer gas from the lungs (by convention, to an end-tidal concentration of 1/40th of the starting concentration over three subsequent breaths).

Innocor uses a combination of two techniques to determine the LCI, using SF6 as the inert tracer gas:

Inert gas rebreathing (IGR) is used for rapid wash-in of a very small amount of SF% until an even concentration is obtained in the lungs before the wash-out can start. This allows accurate determination of the functional residual capacity (FRC) by gas analysis alone.

This is followed by multiple-breath wash-out (MBW) for determination of the cumulative expired volume (VCF) required to clear the SF6 from the lungs. The Innocor device is a compact and portable point-of-care device. The hardware in the LCI Option for Innocor is identical to that used in the Innocor Diagnostic Programmable Computer (K051907) and the Cardiopulmonary Exercise Testing Option to Innocor (K071911). The combined rebreathing/multiple breath wash-out test performed with the LCI Option for Innocor requires accurate measurements of the respiratory flow and the concentration of SF6 at the mouth during inspiration (inhalation) and expiration (exhalation). The Innocor device measures the flow and SF6 concentration by means of of a pneumotachometer and a photoacoustic infrared gas analyzer, respectively, while the patient takes multiple breaths over a period of time through a pneumatically activated respiratory valve unit (RVU). The rebreathing gas mixture for wash-in of SF6 is filled into a rubber bag prior to testing.

Here's an analysis of the acceptance criteria and study information for the LCI Option for Innocor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for LCI or FRC measurements, nor does it present a direct comparison of the device's performance against such criteria. Instead, the performance evaluation is framed as demonstrating "substantial equivalence" to predicate devices and adherence to relevant guidelines.

The performance data described focuses on:

• FRC determination: Evaluated against a calibration syringe.
• LCI determination: Evaluated using data from a simulation model.

The summary states: "Performance data demonstrates that the hardware and software of the LCI Option for Innocor is as safe, as effective, and performs as well as or better than the predicate devices and thus that the device is substantially equivalent to the predicate devices."

Since specific numerical acceptance criteria and a detailed breakdown of the device's measured performance against them are not provided, I cannot create a table with specific numbers. The document relies on a qualitative statement of substantial equivalence.

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

• Sample Size: The document does not specify a sample size for the test set. It mentions evaluation against a "calibration syringe" for FRC and "data from simulation" for LCI. This implies bench testing rather than human subject testing for primary performance evaluation for equivalence.
• Data Provenance: The data provenance is from "bench testing" using a "calibration syringe" and "simulation." This suggests laboratory-based data, not human patient data, and therefore no country of origin or retrospective/prospective designation in the conventional sense for clinical studies.

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

There is no mention of experts being used to establish ground truth for the test set. The ground truth for FRC assessment appears to be the known volume of the calibration syringe, and for LCI, it's derived from a simulation model. This is typical for bench testing where the 'ground truth' is a controlled, known quantity.

4. Adjudication Method for the Test Set

No adjudication method is mentioned or relevant, as the testing described is bench testing against known physical or simulated values, not human expert interpretation.

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 MRMC comparative effectiveness study was done.
• This device is a measurement instrument for physiological parameters (LCI, FRC), not an AI-assisted diagnostic tool that would involve human readers or AI assistance for interpretation. Therefore, human reader improvement with/without AI assistance is not applicable.

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

Yes, a standalone performance evaluation was done. The device, which functions as a "Pulmonary function data calculator," directly measures and calculates LCI and FRC. Its performance was evaluated on its own ("against a calibration syringe for FRC determination and data from simulation for LCI determination") without human operators interpreting results to determine its accuracy. The "software is different from previous models," indicating that the algorithm's performance is primary.

7. The Type of Ground Truth Used

• FRC: Calibration syringe (known, controlled volume).
• LCI: Data from a simulation model.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is consistent with a device that is essentially a physiological measurement calculator, where the calculations are based on established scientific principles rather than a machine learning model that requires a "training set" in the typical sense. The "software is different from previous models" but this likely refers to implemented algorithms for calculation, not machine learning.

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

As no training set is mentioned in the context of machine learning, there is no discussion of how ground truth for a training set was established.

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