Search Results

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.

Ask a specific question about this device

The PulmoTrack 5050 Wholter™ is a non-invasive device intended to acquire, record and store ambulatory respiratory activity from patients for up to 24 hours. It works in concert with the PulmoTrack® Series for playback, review, analysis, editing and printing of respiratory data.

The PulmoTrack 5050 Wholter™ is indicated for but not limited to recording of signals that reflect symptoms such as wheeze and cough.

The PulmoTrack 5050 Wholter™ is a recording device of pulmonary sounds. The device collects the pulmonary data from 4 sensors including a sensor for ambient sounds to reduce background noise. The acquired data is filtered, undergoes A/D conversion and is stored on a flash disk. The digital data is later downloaded to a PC for analyzing using a diagnosis software package.

The PulmoTrack 5050 Wholter™ device consists of:

• . Acoustic sensors (attached to the patient using adhesive pads)
• . Tension-sensitive respiration belt
• . Ambient microphone
• A/D data acquisition device .
• . Firmware and Flash memory
• . USB cable

The provided text describes the PulmoTrack 5050 Wholter™ device, a recording device for pulmonary sounds. However, the document explicitly states that the device itself does not perform diagnosis and therefore does not require clinical testing for its own function. Its safety and efficacy were proven by bench performance tests.

The document mentions that the device is "used in conjunction with an analysis software package that is used by the PulmoTrack 2010 (WIM-PC) (K071955), which has been validated by performance tests for performing diagnosis of the recording." This implies that the diagnostic aspect (which would typically involve acceptance criteria, ground truth, and clinical study details) falls under the "PulmoTrack 2010 (WIM-PC)" software, not the PulmoTrack 5050 Wholter™ recording device itself.

Therefore, based on the provided text, I cannot complete the requested tables and details regarding acceptance criteria and a study that proves the device meets those criteria, as the PulmoTrack 5050 Wholter™ is presented as a data acquisition and recording device, not a diagnostic device with associated performance criteria for diagnosis.

The only "performance data" mentioned for the PulmoTrack 5050 Wholter™ is:

• Performance Testing - bench tests: "The PulmoTrack 5050 Wholter underwent validation testing to ensure performance according to its specifications... All tests demonstrated satisfactory results." No specific acceptance criteria or results are provided for these bench tests.
• Performance Testing - clinical study: "The PulmoTrack 5050 Wholter™ itself does not perform diagnosis and therefore does not require clinical testing. The safety and efficacy of the PulmoTrack 5050 Wholter™ was proven by bench performance tests."

To fulfill your request for acceptance criteria and a study proving their achievement, more information would be needed about the "PulmoTrack 2010 (WIM-PC)" software, which is responsible for the diagnostic analysis.

Ask a specific question about this device

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.

Ask a specific question about this device