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Sentry WEB SmartInterp is a medical software which is intended to be used as an aid in the evaluation and diagnosis of already measured cardiopulmonary data. Access to data will be realized via network or internet with assigned access rights. Patient population is not assigned as it is defined by the measuring devices itself.

Sentry Web SmartInterp is a web application providing support for execution of post-measurement related clinical tasks like re-evaluation, quality grading and interpretation of medical readings. Sentry WEB SmartInterp does not primarily rely on electronic document formats – PDF-like reports – but utilizes modern web technologies to create a rich web-based user experience. Due to its general approach Sentry WEB SmartInterp can serve in many environments as 'the post-measurement' solution - customer-owned or as cloud based software service. Hence, Sentry WEB SmartInterp on one hand extends stand-alone diagnostic systems by running on the measurement system as local post-measurement component. For small labs Sentry WEB SmartInterp enables the attending physician to supervise several measurement units from his office. In mid-sized cardiopulmonary labs Sentry SmartInterp introduces optimized post-measurement workflow WEB capabilities. Finally in sophisticated multi-site setups Sentry WEB SmartInterp supports the channeling of data and creates the throughput required for large clinical teams.

The provided 510(k) summary for the Sentry Web SmartInterp device does not include specific acceptance criteria or a detailed study proving its performance against such criteria in the way typically expected for a diagnostic AI device assessing specific conditions.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. The "acceptance criteria" here are implicitly tied to the performance and safety profiles of the predicate devices.

The study described is primarily a non-clinical performance evaluation focused on software development and safety standards rather than a clinical accuracy study for specific diagnostic outcomes.

Here's an breakdown of the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC values) and consequently does not report device performance against such metrics. The "device performance" in this context refers to its ability to function according to its design and meet various software and safety standards.

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

The document does not specify a "test set" in the context of a diagnostic performance study (e.g., a set of medical images or patient records used to evaluate diagnostic accuracy). The testing performed was primarily non-clinical verification and validation of the software. Therefore, there's no information on sample size or data provenance related to diagnostic performance.

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

As there was no "test set" for diagnostic performance, there were no experts used to establish ground truth for disease diagnoses. The "ground truth" for the non-clinical testing would refer to the expected behavior and outputs of the software based on its design specifications and standard requirements.

4. Adjudication Method

Not applicable, as no diagnostic performance study involving human interpretation and ground truth adjudication was described.

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

No MRMC study was performed or described. The device is presented as an "aid in the evaluation and diagnosis," similar in function to existing predicate software, rather than a system designed to improve human reader effectiveness in a comparative study.

6. Standalone Performance

A standalone (algorithm only) performance evaluation was implicitly conducted as part of the "Accuracy Testing" and "Summary Discussion of Bench Performance Data." The device (software) was tested to ensure it accurately evaluated data and met design specifications.
The statement "The validation and verification testing confirmed this device meets user needs and design inputs for PFT and CPET" and "Accuracy of evaluated Data" falling under "Non-clinical tests" implies standalone functional testing. However, this is not a standalone diagnostic performance study against clinical ground truth.

7. Type of Ground Truth Used

For the non-clinical tests described, the "ground truth" was internal to the development process:

• Design specifications and established standards: For risk management (ISO 14971), usability (EN 62366), and software life cycle (ISO 62304).
• Expected data evaluation outputs: For "Accuracy of evaluated Data," implying that the software's calculations and interpretations were compared against expected correct outputs for various cardiopulmonary data. This is more of a functional and computational accuracy check rather than a clinical diagnostic ground truth.

There was no clinical ground truth (e.g., pathology, clinical outcomes, expert consensus on diagnoses) used in the reported testing.

8. Sample Size for the Training Set

The document does not mention any "training set," which is typically associated with machine learning or AI models. Given the device's description as an "evaluation software" that relies on web technologies and mirrors existing functionalities of predicate devices, it's unlikely to be a machine learning model requiring a distinct training set in the conventional sense. It appears to be a rule-based or algorithmic system that processes and displays data.

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

Not applicable, as no training set was mentioned.

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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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Vyntus Walk is a mobile medical application which is intended to be used on a mobile platform to collect and collate sequential pulse oximetry data during six minute walk tests (6MWT). Pulse oximetry data are collected from an external pulse oximeter, using Bluetooth connection. The mobile platform has access to a host computer with SQL database (SentrySuite) via a wireless network for further data evaluation and diagnosis. Patients as young as 4 years of age and older can be tested providing they can cooperate with the test instructions. Measurements are performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities).

The Vyntus Walk is a tablet based software mobile application that collects and collates pulse oximeter data from an external pulse oximeter during a 6 Minute Walk Test and remotely transmits to the SentrySuite for access to physicians for diagnosis purposes. Vyntus WALK includes wearable, wireless sensors connected to a tablet PC running Android Operating System with a workflow driven 6MWT application. Vyntus WALK integrates seamlessly in today's mobile healthcare environment through the new Sentry CIS™ service landscape for central data management and reporting.

The provided document describes the Vyntus Walk, a mobile medical application designed for collecting and collating pulse oximetry data during Six Minute Walk Tests (6MWT). The document includes a 510(k) summary, which outlines the device's characteristics, intended use, and comparison to a predicate device (SpiroPro K092324). It also summarizes testing performed to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" with numerical thresholds for performance metrics. Instead, it refers to passing applicable tests and standards and demonstrating substantial equivalence to the predicate device. The performance characteristics of the Vyntus Walk and how they relate to the Nonin Oximeter (which it connects to) are listed.

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

• Sample Size for Clinical Test Set: 16 healthy subjects.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the clinical test was performed in September 2014, making it prospective in relation to the submission date.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical test. It only states that the 6MWT was performed "according to ATS criteria," implying standard clinical practice, but not involving independent expert adjudication for ground truth.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method for the clinical test set. The focus was on the direct measurement and recording of data by the Vyntus Walk compared to an external pulse oximeter (Nonin) and the overall successful operation of the device during the ATS-compliant 6MWT.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance:

No, an MRMC comparative effectiveness study was not done. The Vyntus Walk is a data collection and collation tool, not an AI-driven interpretive device that assists human readers in making diagnoses. It facilitates the 6MWT by integrating external pulse oximeter data into a mobile platform.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The document does not specifically describe a "standalone" performance test in the context of an algorithm's diagnostic accuracy. The Vyntus Walk's primary function is as a data collection and display tool for an external oximeter. Its performance evaluation focuses on its ability to accurately collect, collate, and transmit data from the Nonin oximeter. The accuracy of the SpO2 and Heart Rate measurements themselves relies on the connected Nonin Oximeter. The "Accuracy Testing" mentioned was bench testing comparing the proposed device with the predicate device, likely focusing on data handling and display, rather than inherent measurement accuracy as a standalone sensor. The clinical test confirmed the device operated as intended and collected data during a 6MWT successfully.

7. The Type of Ground Truth Used:

For the clinical testing, the ground truth was essentially the real-time physiological data (Heart Rate and SpO2) from an external pulse oximeter (Nonin) during a 6MWT performed according to ATS criteria, and the proper collection and display of this data by the Vyntus Walk. There is no mention of a separate "ground truth" established by experts or pathology for the data itself, as the device is a data handler.

8. The Sample Size for the Training Set:

The document does not provide any information about a training set size. The Vyntus Walk is described as a "mobile medical application," and while software typically undergoes development and internal testing, there's no mention of a "training set" in the context of machine learning or AI algorithm development for a diagnostic task.

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

As no training set is discussed or implied for an AI algorithm, there is no information on how ground truth for a training set was established.

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The MicroLab / MicroLoop spirometer is intended, for prescription use only, to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs and for pulse oximetry measurements. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician offices, laboratories and occupational health testing environments.

The optional Nonin IPOD® Integrated Pulse Oximetry Device is designed to measure pulse rate and oxygen saturation in adult patients. The sensor is designed for use on the fingers of patients weighing more than 30 kilograms, where the finger tissue is between 5 and 21 millimeters.

The MicroLab / MicroLoop is a mains/battery operated desktop spirometer. It has context sensitive help screens, accessed at the touch of a button, that explain its features and navigational aides, making it easy to use. The results may be uploaded to a PC using the optional "Spirometry PC" software and patient details may be downloaded to the MicroLab / MicroLoop. Using spirometry PC software (SPCS) and the MicroLab / MicroLoop, live blows can be performed with the PC directly controlling the operation of the MicroLab / MicroLoop. The results and graphs produced are displayed directly on the PC screen. Stored data on the devices can be printed on an external printer using the USB cable supplied or uploaded to the PC. In addition the MicroLab is able to print the data on its integral thermal printer. Optional a Nonin Ipod® SpO2 sensor can be connected to the MicroLab / MicroLoop.

The scientific concept which forms the basis of the MicroLab / MicroLoop is the CareFusion Digital Volume Transducer, a stable form of volume transducer, which measures expired air directly at B.T.P.S (Body Temperature and Pressure with Saturated water vapour) thus avoiding the inaccuracies of temperature corrections. The transducer is insensitive to the effects of condensation and temperature and avoids the need for individual calibration prior to performing a test.

The provided document is a 510(k) Pre-market Notification for the MicroLab/MicroLoop spirometer and its optional SpO2 module. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel study to prove device meets acceptance criteria through specific quantitative performance metrics beyond what's stated for regulatory compliance.

However, based on the Summary of Device Testing (Section 5.15) and the Summary Discussion of Bench Performance Data in the document, I can infer the acceptance criteria and study approach.

Key takeaway: The submission emphasizes compliance with recognized standards rather than detailing specific de novo performance studies with novel clinical endpoints or expert ground truth.

Here's the breakdown based on the information provided:

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

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 does not specify the sample sizes for the test sets used in the bench testing. It refers to "applicable tests and standards" and "validation and verification testing" but does not provide details on the number of subjects or samples for any specific performance measurement. The focus is on demonstrating compliance with standards rather than a clinical study with a specific patient cohort. The testing was non-clinical (bench testing) and likely conducted in Germany where the company is based.

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 applicable and not provided. The testing described is primarily bench testing against established engineering and performance standards (e.g., ATS/ERS for spirometry, Nonin's own specifications for oximetry accuracy) and regulatory safety standards. There is no mention of human expert-derived ground truth as would be required for diagnostic image analysis or similar AI/ML-driven devices.

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

Not applicable. Adjudication methods typically relate to expert consensus on ground truth in a clinical study. The document describes non-clinical bench testing.

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. The device is a diagnostic spirometer and pulse oximeter, not an AI-assisted diagnostic tool for interpretation by human readers. The submission explicitly states: "Clinical testing was not performed with this device."

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

Yes, the performance testing described is standalone algorithm/device performance. The device provides direct measurements (spirometry parameters, SpO2, pulse rate). The "Summary of Device Testing" (Section 5.15) and "Summary Discussion of Bench Performance Data" (Section 11) describe non-clinical bench tests confirming the device's technical performance against established standards, independent of human interpretation or assistance beyond operating the device.

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

For spirometry, the ground truth would be precise, calibrated flow and volume simulators/generators that meet the reproducibility and accuracy requirements of standards like ATS/ERS.

For oximetry, the ground truth for SpO2 and pulse rate accuracy would be from a reference oximeter or a controlled human desaturation study (though the document states "clinical testing was not performed," implying it relies on the Nonin module's pre-established accuracy or simulated scenarios). The "Accuracy Testing" for the oximetry module would compare its measurements to highly accurate reference instruments under various conditions.

In essence, the ground truth is derived from validated engineering measurement standards and reference devices.

8. The sample size for the training set

Not applicable. This device does not appear to employ machine learning or AI that would require a "training set" in the conventional sense of AI development. It's a traditional medical device based on established physical principles (digital volume transducer for spirometry, light absorption for oximetry).

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

Not applicable, as there is no training set for an AI/ML algorithm.

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

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

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

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

Measurements:

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

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

Here's a breakdown of the requested information:

Acceptance Criteria and Reported Device Performance:

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The 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.

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The Micro I spirometer is intended to measure the maximal volume and flow of air that can be moved out of a patient's lungs. The system is intended for use with pediatic and addlt patients over the age of 3 years in hospitals, physician offices, laboratories and occupational health testing environments.

The Micro I spirometer is a hand held portable microprocessor based device designed to measure expiratory flows and volumes. To perform a spirometry test the user first inserts a mouthpiece into the mouthpiece holder of the spirometer, which aligns it with the volume transducer. The unit is then turned on and displays instructions and prompts according to the device type. When prompted to do so by the operator, the patient inhales as deeply as possible, seals his/her lips around the mouthpiece and exhales as hard and as fast as possible until no more air can be exhaled. The device converts the airflow to an electrical signal, and the onboard software calculates the required values.

Here's an analysis of the acceptance criteria and study information for the Micro I spirometer, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Device Testing (Evidence of Meeting Acceptance Criteria):

The document states that the following practices were followed and monitored for the development of the Micro I Spirometer, forming the basis of its substantial equivalence claim:

• Design and Development QP 0301: Device was developed in accordance with CareFusion's internal design and development quality procedure.
• IEC 62366 (Usability): Modifications were developed according to this usability standard.
• ISO 14971 (Risk Analysis): A Failure Modes and Effects Analysis (FMEA) was used to assess the impact of modifications.
• Biocompatibility (ISO 10993-1): Tested for patient-contacting materials at Nelson test laboratory in the USA.
• Safety and EMC Testing (IEC 60601-1 and IEC 60601-2): Device underwent electrical safety and electromagnetic compatibility testing.
• Packaging Test: Performed.
• Environmental Testing (Climatic Chamber): Performed to evaluate performance under various environmental conditions.
• Testing according to ATS/ERS standardization of lung function testing: This is the most direct evidence for the spirometry performance characteristics (accuracy, volume/flow ranges, etc.). The device's accuracy and volume/flow ranges are stated to be "Identical to K100928" or "as per ATS/ERS," directly referring to these standards as the acceptance criteria.

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set. It mentions "Testing according ATS/ERS standardization of lung function testing," which implies that the device was validated against the performance requirements outlined in these standards. However, the exact number of test subjects or a specific test dataset is not provided.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. The testing was carried out by CareFusion internally and via a third-party lab (Nelson Test Laboratory for biocompatibility, located in the USA).

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a test set in the traditional sense of clinical studies with expert reviewers. The ground truth for spirometer performance is typically established by comparing the device's measurements against established, precisely calibrated reference systems or standards (like those from ATS/ERS).

4. Adjudication Method

Not applicable. Since the 'ground truth' for this type of device is based on technical standards and calibrated measurements rather than expert consensus on diagnostic images or clinical outcomes, an adjudication method like 2+1 or 3+1 is not relevant here.

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

No. This type of study (MRMC) is typically performed for AI-powered diagnostic devices where human readers are interpreting data (like medical images) with and without AI assistance to measure improvement in diagnostic performance. The Micro I is a measurement device (spirometer), not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Yes, implicitly. The "Testing according ATS/ERS standardization of lung function testing" would be a standalone performance evaluation of the device's measurement algorithms and hardware against established standards, without human interpretation as part of the primary measurement. The spirometer outputs numerical values (e.g., FEV1, FVC), and its accuracy is assessed against a gold standard for these measurements.

7. Type of Ground Truth Used

The ground truth used for performance evaluation is technical standards and calibrated measurements, specifically those established by the American Thoracic Society (ATS) / European Respiratory Society (ERS) standardization of lung function testing (2005). These standards define the acceptable accuracy, volume range, and flow range for spirometers.

8. Sample Size for the Training Set

Not applicable. The Micro I spirometer is described as a microprocessor-based device converting airflow to an electrical signal, and
calculating values using "onboard software." It does not appear to be an AI/machine learning-based device that would typically have a "training set" in the sense of supervised learning. Its algorithms are likely deterministic and based on physical principles of flow and volume measurement.

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

Not applicable, as there is no mention or indication of a training set in the context of machine learning. The device's operation is based on established scientific principles and engineering design, with performance validated against international standards.

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The CareFusion MicroGard® II filter series is indicated for use in prevention of contamination of pulmonary function testing equipment and associated valves and hoses by aerosols and particulates which may be present in a patient's exhaled gas volumes. The MicroGard® II filter should be used only on patients with a minimum body weight of 27.5 kg.

The CareFusion MicroGard II filter is a disposable barrier type filter intended to protect both, patient and instrument, by preventing the transmission of pathogens by droplets and aerosolized particles between the patient and the spirometer, or pulmonary function testing instrument.

The provided text describes the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of the MicroGard II filter to its predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The resistance and filter efficiency for B. atrophaeaus and MS-2 coliphage were measured at different flow rates or were new tests for the MicroGard II, indicating an improvement or additional testing for the modified device.

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

The document mentions that filtration efficiency has been tested at Nelson test laboratory in the USA and at Health Protection Agency in the UK. However, it does not explicitly state the sample size used for these tests. The data provenance is from USA and UK laboratories, and based on the context of testing a manufactured medical device, these would be prospective tests performed on the device.

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 in the document. The testing described (filtration efficiency, biocompatibility, resistance, dead space) are objective laboratory measurements, not subjective evaluations requiring expert interpretation of ground truth in the same way, for example, a diagnostic imaging study would.

4. Adjudication method for the test set:

This information is not applicable for the type of objective laboratory testing described. Adjudication methods are typically used when there are disagreements among experts in subjective evaluations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device described is a physical filter for pulmonary function testing equipment, not an AI-powered diagnostic tool requiring human reader studies.

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

This is not applicable. The device is a physical filter, not an algorithm.

7. The type of ground truth used:

For the performance specifications (resistance, dead space, filtration efficiency), the "ground truth" is established through standardized laboratory testing protocols and measurements. For biocompatibility, the ground truth is established through biocompatibility testing according to ISO 10993-1 standard.

8. The sample size for the training set:

This information is not applicable. The document describes a physical medical device (a filter), not an AI algorithm that requires a training set.

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

This information is not applicable as there is no training set for a physical filter.

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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 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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