(207 days)
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
| Acceptance Criteria (from predicate device's substantial equivalence) | Reported Device Performance (PulmoTrack™ 2020) |
|---|---|
| Acquisition, amplification, filtering, recording, and analysis of pulmonary sounds from trachea and thorax. | "underwent validation testing to ensure performance according to its specifications and as good as the predicate devices. All testing results demonstrated satisfactory performance." |
| Provides high fidelity audio outputs, visual displays, printed reports, and automated identification of lung sounds. | "underwent validation testing to ensure performance according to its specifications and as good as the predicate devices. All testing results demonstrated satisfactory performance." |
| Quantification of wheezing. | "underwent validation testing to ensure performance according to its specifications and as good as the predicate devices. All testing results demonstrated satisfactory performance." |
| Biocompatibility of materials in contact with the human body. | "Materials of the PulmoTrack™ 2020 that are in contact with the human body are biocompatible in accordance with ISO 10993-1." |
| Wireless data transfer functionality (Bluetooth). | "The Bluetooth is substantial equivalence to HOSPIRA Vital Signs Wireless Monitoring System, cleared in K090610" and "underwent validation testing to ensure performance according to its specifications and as good as the predicate devices. All testing results demonstrated satisfactory performance." |
| Compliance with relevant medical device standards (e.g., IEC 60601-1, IEC 60601-1-2, EN ISO 10993-1, ISO 14971). | "The system complies with the following standards: IEC 60601-1:1998, IEC 60601-1-2:2001 and IEC 60601:2005, EN ISO 10993-1:2003, ISO 14971:2007." |
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.
§ 868.1900 Diagnostic pulmonary-function interpretation calculator.
(a)
Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.(b)
Classification. Class II (performance standards).