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The SentrySuite Product line is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece, a mask or nasal adapters. The results of the test can be viewed online with the help of a computer screen and can be printed after the test. The test results can be saved for further referral or report generation purposes. Use of the Option Bronchial Challenge requires the supervision of a physician familiar with emergency medicine.

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

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

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

Measurements:

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

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

Here's a breakdown of the requested information:

Acceptance Criteria and Reported Device Performance:

Study that Proves the Device Meets Acceptance Criteria:

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

   • Sample Size: The document states that "Human subjects were tested," but does not explicitly provide the number of subjects used in the test set.
   • Data Provenance: The study was likely conducted by CareFusion Germany 234 GmbH, suggesting data of European origin (Germany). The study involved "human subjects" tested on the devices. It appears to be a prospective study where new data was collected for the purpose of comparing the two software versions on the same subjects.

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

   • This type of study does not involve "ground truth" established by experts in the sense of a diagnostic interpretation task. Instead, the study compares the measurements generated by two software versions (new SentrySuite 2.7 vs. predicate JLAB) on physical measurements from human subjects. The gold standard in this context is the predicate device's established performance, and the "ground truth" for each measurement is effectively the value reported by the predicate JLAB software. There isn't an expert review process for determining the "truth" of a spirometry reading in this comparison.

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

   • Not applicable. This was a direct comparison of numerical outputs from two software versions, not an interpretation task requiring adjudication.

4. 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 software update for pulmonary function testing equipment, which measures physiological parameters. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data with and without AI.

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

   • Yes, this study is effectively a standalone performance evaluation of the SentrySuite 2.7 software compared to the predicate JLAB software. While both systems are used by humans to perform measurements, the comparison itself focuses on the outputs generated by the software algorithms from the same physical inputs (human subject physiological responses). The study assesses the statistical correlation between these direct algorithmic outputs.

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

   • The "ground truth" in this context is the performance of the legally marketed predicate device running the JLAB software. The new SentrySuite 2.7 software is being evaluated for substantial equivalence to the predicate, meaning its outputs should be statistically similar to those of the predicate when given the same inputs.

7. The sample size for the training set:

   • The document describes a comparison study, not the development of a machine learning model, so there is no "training set" in the traditional sense for an AI/ML algorithm. The software is stated to "supersede" previous versions and "replaces" existing software, implying a re-implementation or enhancement of established algorithms, rather than training a de novo AI model.

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

   • Not applicable, as there is no training set for an AI/ML algorithm described in this submission. The ground truth for the comparison study is the predicate device's performance.

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The SentrySuite Product line is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece, a mask or nasal adapters. The results of the test can be viewed 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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