(470 days)
The SonoSentry™ WheezeRate™ Detector is intended to detect and record abnormal breath sounds (continuous adventitious breath sounds/CABS) at the windpipe (trachea), reported as WheezeRate™ in adults and children (2 years and older). WheezeRate™ represents the percentage of abnormal breath sound detected during the measurement time. A licensed health care professional's advice is required to understand the meaning and importance of the SonoSentry™ readings.
The SonoSentry™ WheezeRate™ Detector is a hand-held electronic measurement device that utilizes an acoustic contact sensor to acquire, amplify, filter, record and analyze breath sounds at the trachea for the presence of continuous adventitious breath sounds/CABS. The device calculates and outputs a WheezeRate™ based on the amount of abnormal breath sounds detected in a given time. The device is designed for use in adults and children (ages 2 years and older).
The SonoSentry™ WheezeRate™ Detector consists of:
- . An acoustic contact sensor
- . An air-coupled electret microphone for ambient noise reiection module
- LCD screen to display measurement results .
- . 4 user buttons
- . Signal conditioning and digitization PCB
- Dedicated DSP .
- . SDRAM memory
- . Embedded software
Here's a breakdown of the acceptance criteria and study information for the SonoSentry™ WheezeRate™ Detector, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a specific performance metric table with pass/fail thresholds. However, it does state the device's intended use and the outcome of the clinical study.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to detect and record continuous adventitious breath sounds (CABS), including wheeze. | Demonstrated an acceptable agreement with physician detection of CABS in a a clinical study |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact number of participants (pediatric and adult) in the clinical study that formed the test set. It mentions "pediatric and adult study subjects."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study subjects had "a previous diagnosis of moderate to severe asthma." The study appears to be prospective since it describes "Sound files... were analyzed by the SonoSentry and an Expert Panel."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: An "Expert Panel" was used, but the exact number of experts is not specified.
- Qualifications of Experts: The Expert Panel consisted of "Board Certified Pulmonologists."
4. Adjudication Method for the Test Set
The document states that an "Expert Panel consisting of Board Certified Pulmonologists" analyzed the sound files. It doesn't explicitly detail a specific adjudication method like "2+1" or "3+1." It implies a consensus or agreement by the panel.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? Yes, the document explicitly states, "The Multiple Reader/Multiple Case Study demonstrated an acceptable agreement between the output of the SonoSentry and physician detection of CABS."
- Effect size of human readers improve with AI vs without AI assistance: The document does not provide any specific effect size or quantitative measure of how much human readers improved with AI assistance compared to without it. It only states that there was "acceptable agreement" between the device and physician detection. The study seemed to compare the device's performance against physician assessment, rather than human performance with the device versus without it.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study was done. The clinical study describes the SonoSentry analyzing sound files and its output being compared to physician assessment. This indicates a standalone evaluation of the algorithm's performance without direct human-in-the-loop assistance for the physicians in the comparison.
7. Type of Ground Truth Used
The ground truth used was expert consensus / physician assessment. Specifically, it was established by an "Expert Panel consisting of Board Certified Pulmonologists" who analyzed the same breath sounds.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set of the SonoSentry™ WheezeRate™ Detector or its underlying algorithm.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the training set was established. It only discusses the clinical study used for performance evaluation (test set).
§ 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).