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The PulmoTrack TM 2020 is intended for the analysis, interpretation and documentation of lung sounds. The PulmoTrack TM 2020 is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds. The PulmoTrack TM 2020 is indicated for patient population above two years old

The PulmoTrackTM 2020 is a computer based electronic stethoscope that utilizes an acoustic contact sensor to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax and provides high fidelity audio outputs, visual displays, printed reports and automated identification of lung sounds. The data transfer may be done via Bluetooth wireless communication.

The PulmoTrack™ 2020 is a computer-based electronic stethoscope that acquires, amplifies, filters, records, and analyzes pulmonary sounds. Its intended use is for the analysis, interpretation, and documentation of lung sounds, specifically quantifying the presence of wheezing during pulmonary function testing, provocation tests, bronchodilator administration, or physical examinations. It is indicated for patients above two years old, to be used by or under the supervision of a physician.

This device did not undergo a clinical study as it claimed substantial equivalence to its predicate device, PulmoTrack™ 2010 (WIM-PC™) (K071955), without raising new safety and/or effectiveness concerns. The only technical modification was the data transfer from A/D to the PC via a Bluetooth wireless channel. Therefore, the performance validation focused on demonstrating that the PulmoTrack™ 2020 performed according to its specifications and as well as the predicate device, particularly concerning biocompatibility and wireless functionality.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

A specific "test set" for a clinical performance study (as would be typical for a novel device) is not explicitly described. Because this was a 510(k) submission based on substantial equivalence to a predicate device with only a minor technological change (Bluetooth), the performance validation was likely focused on technical specifications and functional testing rather than a clinical study with a patient test set. The document states "All testing results demonstrated satisfactory performance," implying internal verification and validation activities. There is no information provided about country of origin of data or whether it was retrospective or prospective.

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

Not applicable. No clinical study involving a test set and expert ground truth establishment is described for the PulmoTrack™ 2020 in this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. No clinical study involving a test set and adjudication is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. No MRMC study was conducted or described. The PulmoTrack™ 2020 is an electronic stethoscope that provides analysis and interpretation of lung sounds, but the provided documentation does not detail a study comparing human reader performance with and without AI assistance.

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

The device itself is an electronic stethoscope with automated identification of lung sounds. The "Performance Validation" section broadly states that the device "underwent validation testing to ensure performance according to its specifications." This would imply standalone performance testing for its ability to analyze and identify lung sounds as per its design. However, specific details of such standalone testing (e.g., against a known dataset of pre-recorded lung sounds with established ground truth) are not provided in this 510(k) summary.

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

The document does not explicitly state the type of ground truth used for validating the automated identification of lung sounds. For a device like this, ground truth would typically come from:

• Expert auscultation/consensus: A panel of experienced physicians listening to the same lung sounds and agreeing on the presence or absence of wheezing.
• Spirometry/pulmonary function tests: Objective measures of lung function that correlate with the presence of wheezing.

Given the nature of the submission (substantial equivalence with minor changes), it's more likely that the validation focused on ensuring the device accurately captured and processed sounds, and that its automated identification algorithm performed comparably to the predicate device, which would have had its own original validation methods for ground truth.

8. The sample size for the training set

Not applicable. The document does not describe a new training set for an AI/algorithm. The device is claiming substantial equivalence to a predicate, implying it uses the same underlying technology/algorithms as the PulmoTrack™ 2010.

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

Not applicable. As no new training set is described for the PulmoTrack™ 2020, how its ground truth was established is not part of this submission. It would rely on the original methodologies used to develop and validate the predicate device's technology.

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The PERSONAL WHEEZOMETER™ is intended for quantifying the presence of wheezing. This device should be used under the direction of a physician or licensed healthcare professional for monitoring acoustic pulmonary functions.

The PERSONAL WHEEZOMETER™ ™ is a hand-held electronic measurement device that utilizes an acoustic contact sensor to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea for the presence of wheczes. The device outputs a wheezerate score based on the amount of wheezing detected in a given time. The PERSONAL WHEEZOMETER™ (PW) is intended to be a home use version of the PulmoTrack® (K980878) and PulmoTrack model 2010 (WIM-PC) (K071955), providing wheeze-rate information for both home and clinical settings.

The PERSONAL WHEEZOMETER™ device consists of:

• An acoustic contact sensor
• An air-coupled electret microphone for ambient noise rejection module.
• LCD screen to display measurement results
• 4 user buttons
• Signal conditioning and digitization PCB
• Dedicated DSP
• SDRAM memory
• Embedded software.

This 510(k) summary does not contain sufficient information to comprehensively answer all aspects of your request. Specifically, it lacks detailed quantitative acceptance criteria and the results of the performance study against those criteria, as well as specific information about ground truth establishment and training set details.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified for the clinical study.
• Data Provenance: The document states that KarmelSonix is an Israeli company and the contact person is from Israel. The clinical study was likely conducted in Israel, but this is not explicitly stated. The study is prospective, as it's a "clinical usability study" performed with the device.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. (It's unclear if experts were even used to establish ground truth for wheezing, as the study primarily focused on usability.)

4. Adjudication method for the test set

• Not specified. Given the focus on usability, a formal adjudication process for wheeze detection may not have been the primary objective.

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

• A MRMC comparative effectiveness study was not conducted. The study described is a "clinical usability study" of the device itself, not a comparative study with human readers or AI assistance.

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

• The device, PERSONAL WHEEZOMETER™, is essentially a standalone algorithm for quantifying wheezing, displaying a "wheezerate score." The "clinical usability study" would inherently assess its standalone performance in a real-world user context. However, specific metrics of algorithm-only performance (e.g., sensitivity/specificity against a gold standard) are not detailed.

7. The type of ground truth used

• The document does not explicitly state the type of ground truth used for evaluating wheezing detection. Given the clinical usability study context, it's possible that clinical assessment by physicians (expert consensus) or correlation with other diagnostic tools might have been informally used, but this is not detailed.

8. The sample size for the training set

• Not specified. The document does not mention details about a training set, implying a pre-trained algorithm or an algorithm developed without a distinct "training set" in the context of this submission. The device is a home-use version of previously cleared devices (PulmoTrack® and PulmoTrack model 2010), so its core algorithms might have been developed and validated previously.

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

• Not specified, as details about a training set are not provided.

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The WIM-PCTM is intended for the analysis, interpretation and documentation of lung sounds. The WIM-PC™ is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds.

The WIM-PC™ is a computer based electronic stethoscope that utilizes two contact sensors simultaneously to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax and provides high fidelity audio outputs, visual displays and printed reports. The WIM-PCTM system consists of: Acoustic sensors (attached to the patient using adhesive pads), Sensor pod with a built-in dielectric microphone for ambient noise pick-up, Tension-sensitive respiration belt, A/D data acquisition device, USB cable and signal cable, Laptop PC unit with Data Analysis software.

The provided document is a 510(k) summary for the WIM-PCTM device by KarmelSonix Israel Ltd. It focuses on demonstrating substantial equivalence to a predicate device (PulmoTrack™ model 1010) and outlines the validation tests performed. However, it does not contain detailed information about specific acceptance criteria, comprehensive study results (like sensitivity/specificity, effect sizes), or the detailed methodology of how ground truth was established for a testing or training set in the way a clinical study report would.

Therefore, I can only extract limited information based on what is present in the document.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Wheeze detection validation test" and "Breath detection validation test" as performed on the software, but it does not provide specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, or agreement rates) nor does it report the quantitative performance results of these tests.

2. Sample Size and Data Provenance for the Test Set

The document does not specify the sample size used for the "Wheeze detection validation test" or "Breath detection validation test." It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

The document does not mention the number of experts used or their qualifications for establishing ground truth in the reported validation tests.

4. Adjudication Method (Test Set)

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, no effect size for human reader improvement with AI assistance can be determined from this text.

6. Standalone Performance Study

Yes, a standalone validation was performed for the device's software components. The document explicitly states:

• "The following validation tests were performed on the WIM-PCTM software:
  • Wheeze detection validation test.
  • Breath detection validation test."
    However, the actual performance metrics (e.g., sensitivity, specificity, accuracy) are not reported.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the "Wheeze detection validation test" or "Breath detection validation test." Given the nature of pulmonary sound analysis, it's highly likely to be expert consensus (e.g., auscultation by physicians) or potentially correlated with other clinical findings, but this information is not provided.

8. Sample Size for the Training Set

The document does not specify the sample size used for training the software algorithms.

9. How Ground Truth for the Training Set was Established

The document does not describe how the ground truth for the training set was established.

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The Stethographics STG Multichannel Lung Sound Analysis system is intended for the recording, audio reproduction, graphic display and automated identification of lung sounds. It can be configured to record from one or more than one channel.

The Stethographic STG Monitor Multichannel Lung Sound Analysis System Comprises Chest pad with electronic stethoscopes, back pad, pre-amplifier, connection hub, and a PC computer. The system also includes a printer, a cart, speakers, headphones, re-writable CDs for data storage and custom software. The system is non-invasive with patient contact disposable cotton cover.

The provided text describes the STG Monitor Multichannel Lung Sound Analysis System and its 510(k) submission. However, it does not contain specific acceptance criteria, detailed study results, or information regarding sample sizes, expert qualifications, or ground truth establishment relevant to the device's performance.

The document explicitly states:

• "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Stethographic STG Monitor Multichannel Lung Sound Analysis System is same as the predicate device." This indicates that the device's performance was evaluated by demonstrating equivalence to a predicate device (Pulmotrack, Model 1010, K980978), rather than against specific, quantitative acceptance criteria for its own performance.

Therefore, many of the requested details about acceptance criteria and study particulars cannot be extracted from this document.

Here's an attempt to answer the questions based only on the provided text, with clear indications where information is missing:

1. 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)

• Sample size for test set: Not provided.
• Data provenance: Not provided. The document mentions "bench and laboratory testing," which typically implies controlled environments but does not specify the origin or nature of the data.
• Retrospective or prospective: Not provided.

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)

• Not provided. The document focuses on demonstrating equivalence to a predicate device, and does not detail a process for establishing ground truth via expert consensus for a test set.

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

• Not provided.

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

• Not explicitly stated or implied. The device's primary function is for "recording, audio reproduction, graphic display and automated identification of lung sounds." While it's a "Pulmonary Function Interpretator," the document does not mention studies involving human readers or AI assistance in a comparative effectiveness context. The focus is on the device's functional equivalence to a predicate.

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

• The device's description, particularly "automated identification of lung sounds," suggests a standalone algorithmic component. However, specific standalone performance study details (metrics, results) are not provided. The performance statement only refers to being "same as the predicate device."

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

• Not explicitly stated. Given the device's purpose, "automated identification of lung sounds," the ground truth likely related to correctly identifying specific lung sounds or their characteristics, but the method for establishing this ground truth is not detailed. The comparison to a predicate device implies that the predicate's established performance served as a de facto benchmark.

8. The sample size for the training set

• Not provided. This document discusses regulatory approval for a device, not the specifics of its internal algorithm training.

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

• Not provided.

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The PulmoTrack Model 1010 is intended for the analysis, interpretation and documentation of lung sounds.

The PulmoTrack Model 1010 is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in a pulmonary function testing environment when there is a need to perform an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds.

The PulmoTrack is a computer based electronic stethoscope that utilizes up to five contact sensors simultaneously to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax and provides high fidelity audio outputs, visual displays and printed reports.

I am sorry, but the provided text does not contain the information required to answer your request. The document describes the PulmoTrack Model 1010 device and its substantial equivalence to predicate devices, along with its indications for use. However, it does not include details about acceptance criteria, specific studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

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The ORCA System is indicated for use in exercise tests where the collection and analysis of gas exchange and extraction of pulse rate information from ECG during exercise stress testing is needed. Further, the device will suggest interpretive statements based on the results of the analysis and the reasons for the test termination. The intended patients are adults and children and the intended environment of use is indoors.

The ORCA Cardiopulmonary Exercise Testing System is a self-contained unit designed to provide patient respiratory gas exchange data during exercise stress testing. The system consists of components which measure the flow of exhaled air, and analyze the oxygen and carbon dioxide content of the exhaled air. A transcutaneous pulse oximeter reports heart rate and oxygen content of the arterial blood. Instruments are interfaced to a Pentium-based personal computer through a 16 channel, 12 bit analog/digital converter. As an option, information can be integrated with electrocardiographic information provided by external EKG equipment (EKG equipment is not provided with the ORCA system). Software collects and analyzes data, summarizes results and suggests possible implications of abnormalities observed.

The provided text describes the ORCA Cardiopulmonary Exercise Testing System and its substantial equivalence to predicate devices, but it does not contain detailed information about specific acceptance criteria, comprehensive device performance data, or a study report with methodological details commonly found for proving such criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing a standalone clinical study report with detailed performance metrics. Therefore, many of the requested details are not explicitly present in the provided text.

Based on the available information, here's what can be inferred and what is missing:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The document primarily focuses on establishing substantial equivalence to predicate devices rather than detailing specific, quantified acceptance criteria and a study to prove the device meets these criteria as if it were a novel device requiring de novo authorization.

The "acceptance criteria" here are implicitly related to the device having similar performance, features, and intended use as the predicate devices (MedGraphics Exercise Consult K923209 and Sensormedics Vmax 229 K942211). The "study" proving this is the 510(k) submission itself, which argues for substantial equivalence by comparing the ORCA system to these predicates.

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

Since the regulatory pathway is 510(k) and focuses on substantial equivalence, explicit quantitative acceptance criteria for performance metrics in a pass/fail format are not presented. Instead, the document compares the features and intended use of the ORCA system to its predicates.

Missing Information: Quantitative performance metrics (e.g., accuracy, precision, repeatability for O2/CO2 measurement, flow measurement, pulse rate measurement, or the interpretive statements' accuracy) are not provided in this 510(k) summary. The "acceptance criteria" appear to be met by demonstrating similar functionality and intended use to the predicate devices.

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

This information is not provided in the 510(k) summary. The document does not describe a specific clinical "test set" and study data for the ORCA system in the way a clinical trial would. The basis for equivalence is primarily a comparison of device specifications and intended use against existing, cleared devices.

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/not provided by the document. The 510(k) summary does not describe a process of establishing ground truth with experts for a test set, as would be done for an AI diagnostic device requiring such validation. The interpretive statements feature is mentioned, but its validation methodology isn't detailed here.

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

This information is not applicable/not provided by the document. There is no mention of a test set requiring adjudication in this 510(k) summary.

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 information is not applicable/not provided by the document. The ORCA system is described as generating interpretive statements, but not as an "AI assistance" device in the context of improving human reader performance via an MRMC study. It's a system to collect and analyze physiological data and provide interpretive statements based on that analysis.

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

The device is described as assisting in "collection and analysis of gas exchange and extraction of pulse rate information" and will "suggest interpretive statements." This suggests a standalone analytical component. However, specific standalone performance metrics (e.g., accuracy of interpretation) are not detailed in the provided summary. The focus is on the device as a whole system.

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

This information is not provided for any validation of the interpretive statements. For the measurements (O2, CO2, flow, pulse rate), the implied "ground truth" would likely be comparison to reference measurement devices or established calibration standards, but specifics are missing from this summary.

8. The sample size for the training set

This information is not provided. The 510(k) summary does not mention a "training set," implying that if any algorithms are used for interpretation, they are based on established physiological models or rules rather than machine learning trained on a dataset.

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

This information is not applicable/not provided. Without a mention of a training set, there's no information on how its ground truth would have been established.

In summary: The provided 510(k) document serves to demonstrate substantial equivalence based on device features and intended use, rather than a detailed performance study with explicit acceptance criteria and validation data as typically required for novel or high-risk devices or AI/ML-enabled devices today. The "study" for acceptance here is the comparison presented in the 510(k) application itself, aligning the ORCA system's attributes with those of the predicate devices.

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