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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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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:

Ask a specific question about this device

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 on-line 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

The provided text is a 510(k) summary for the SentrySuite Product Line, which is a software for lung function measurements. It describes the device, its intended use, and its comparison to predicate devices, but does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically understood in the context of clinical performance evaluation with metrics like sensitivity, specificity, or accuracy.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily by highlighting that the updated SentrySuite software (version 2.5) replaces an older version (2.3) and incorporates the functionality of another predicate device (MasterScreen PFT K072061). The "Summary of Device Testing" section mentions adherence to development standards (CareFusion Design and Development SWI, IEC 62304, IEC 62366) and risk analysis (ISO 14971 FMEA), but these are related to software development and validation processes, not performance evaluation against specific clinical acceptance criteria.

Therefore, many of the requested details cannot be extracted directly from this document.

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

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

This information is not provided in the document. The submission focuses on device modifications and substantial equivalence to predicates, not on specific performance metrics or acceptance criteria for those metrics. The performance is implied to be "identical" or "equivalent" to the predicate devices.

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

• Sample size for test set: This information is not provided.
• Data provenance: This information is not provided. The document does not describe any specific clinical or performance test data.

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

This information is not provided as there is no description of a clinical or performance test that would require expert-established ground truth.

4. Adjudication method for the test set:

This information is not provided as there is no description of a clinical or performance test that would require adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

This information is not provided. The document does not describe any MRMC study or any study involving human readers with or without AI assistance.

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

The device is a "PFT data calculator" and "pulmonary function data calculator," which implies an algorithm-only function. However, no standalone performance study results, in terms of specific metrics, are presented. The "performance specification" listed in the tables refers to the types of measurements the device can perform (e.g., Spirometry, Flow/Volume), not performance metrics like accuracy or reliability.

7. The type of ground truth used:

This information is not provided because specific performance testing against ground truth is not detailed in this submission.

8. The sample size for the training set:

This information is not provided. The document describes software development and changes, but does not mention any machine learning or AI models that would require training data.

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

This information is not provided.

Summary of what the document DOES provide regarding "testing":

The "Summary of Device Testing" (Section 5.15) states that:

• The device modification was developed in accordance with CareFusion Design and Development SWI (0301-5001-000-SWI).
• The software was developed according to IEC 62304 (Software life-cycle processes) and IEC 62366 (Usability) standards.
• Risk analysis was performed using FMEA according to ISO 14971.

These are process-oriented validations and risk management activities, typically required for software medical devices, rather than clinical performance studies demonstrating accuracy, sensitivity, or specificity against specific acceptance criteria. The conclusion (Section 5.16) is based on "substantial equivalence" to predicate devices, implying that since the new software maintains identical functionality and performance specifications to previously cleared devices, it is considered safe and effective.

Ask a specific question about this device

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 and APS Pro 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

Carefusion Germany 234 GmbH's SentrySuite Product line is a software modification that replaces the JLAB software for existing hardware (MasterScreen Pneumo, MasterScreen IOS, APS Pro) used for pulmonary function testing. The 510(k) submission (K111053) focused on demonstrating substantial equivalence to the predicate devices with the JLAB software.

No specific acceptance criteria or a dedicated study demonstrating the device meets acceptance criteria are explicitly detailed in the provided K111053 summary.

However, the submission outlines the general approach taken to ensure the new software performs at least as well as the predicate devices, focusing on the equivalence of its functionality and adherence to relevant standards.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not include a table of explicit acceptance criteria with quantitative performance metrics for the SentrySuite Product line. Instead, it states that the SentrySuite software provides the functionality currently available on the MasterScreen devices using the JLAB software and that "The measurement programs for the medical applications for each device remain the same."

The declaration of substantial equivalence implies that the SentrySuite software is expected to maintain the performance characteristics of the predicate devices. The performance specifications listed in the comparison table (3) under the "Perfor-mance specifica-tion (measure-ment programs)" indicate the types of measurements the device can perform, which are "identical" to the predicate devices.

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

The 510(k) summary does not specify a sample size for a test set or data provenance in direct relation to evaluating the performance of the SentrySuite software against acceptance criteria. The focus of this 510(k) appears to be on the software change, and the demonstration of equivalence is primarily based on the functional identity of the measurement programs and adherence to software development and risk management standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable and not provided in the context of this 510(k) submission. The device is a pulmonary function testing system that measures parameters. The "ground truth" for such devices typically comes from established calibration standards and physiological measurements, not expert interpretation of results for diagnostic accuracy in the way an imaging AI might.

4. Adjudication Method for the Test Set

This information is not applicable and not provided for the reasons stated above.

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

An MRMC study was not conducted and is not relevant for this type of device. The SentrySuite Product line is a measurement and data collection system, not an AI diagnostic tool requiring human reader interpretation with or without AI assistance.

6. Standalone Performance Study

While not explicitly called a "standalone performance study" in the common sense of AI algorithm evaluation, the software was developed according to:

• CareFusion Design and Development SWI (0301-5001-000-SWI)
• IEC 62304 (Software life-cycle processes)
• IEC 62366 (Usability) standard

This indicates internal verification and validation activities specific to the software's functionality, safety, and usability. The summary states: "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." This suggests that the internal testing aimed to confirm that the new software performs measurements equivalently to the old software, effectively serving as a standalone evaluation of the new software's capabilities.

7. Type of Ground Truth Used

The concept of "ground truth" as pathology or outcomes data is not directly applicable here. For pulmonary function devices, the "ground truth" would relate to the accuracy and precision of the measurements obtained (e.g., spirometry, flow volume, MVV) against recognized calibration standards or accepted physiological models. The submission implies that the measurement programs being "identical" to the predicate devices' programs means they adhere to the same established physiological measurement principles and accuracy.

8. Sample Size for the Training Set

There is no mention of a training set sample size. This device is a software update for a measurement system, not a machine learning or AI model that requires a "training set" in the conventional sense.

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

This question is not applicable as there is no indication of a training set being used for this software modification. The software's functionality is based on established algorithms for pulmonary function measurements, not on learned patterns from a dataset.

Summary of the Study and Evidence for Equivalence:

The primary "study" and evidence presented in K111053 to demonstrate the device meets acceptance criteria (implied as being equivalent in function and safety to the predicate devices) are through:

• Comparison to Predicate Devices: A detailed comparison table (3) is provided, highlighting that the "SentrySuite Product line" has identical indications for use, patient population, hardware, performance specifications (measurement programs), energy type, patient-contacting parts, sterilization, and software network options compared to the predicate devices, except for the software name itself (SentrySuite replaces JLAB).
• Software Development Standards: Adherence to established software development and usability standards (IEC 62304, IEC 62366) and the company's internal design and development procedures (CareFusion Design and Development SWI).
• Risk Analysis: A Failure Modes and Effects Analysis (FMEA) according to ISO 14971 was performed to assess the impact of the new software.
• Claim of Functional Equivalence: The submission explicitly states: "Measurement can be accomplished under SentrySuite software equivalent as it was possible under the previously powerful JLAB software." and "The measurement programs for the medical applications for each device remain the same."

Essentially, the document argues that because the new software performs the same functions using the same measurement programs on the same hardware as the legally marketed predicate devices, and was developed under stringent quality and risk management standards, it is substantially equivalent and thus meets the implicit acceptance criteria of being safe and effective for its intended use, performing at least as well as the predicate devices.

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