(266 days)
The TytoCare Lung Sounds Analyzer is an over-the-counter decision support software system used in the evaluation of lung sounds in adults and children (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of "Wheeze" is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional's advice is required to understand the meaning of the TytoCare Lung Sounds Analyzer result. Healthcare provider should consider the device result in conjunction with recording and other relevant patient data.
The TytoCare Lung Sounds Analyzer is a web-based software system designed to aid in the clinical assessment of lungs auscultation sound data by analyzing recorded lung sounds to determine whether a Wheeze is detected within the recorded sound data.
The TytoCare Lung Sounds Analyzer Software is intended to process recordings from the FDA-cleared compatible Tyto Stethoscope (Tyto Stethoscope, K181612). The acquisition of the acoustic data (recordings) is carried out by a professional user in a clinical environment or by a lay- user in a non-medical environment, in compliance with the labeling of the Tyto Stethoscope.
The system is composed of the following sub-systems:
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- The TytoCare Lung Sounds Analyzer Application Server (APS) communicates with the TytoCare Lung Sounds Analyzer Algorithm Server (ALS) and implements an application programming interface (API) for communication with the telehealth server.
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- The TytoCare Lung Sounds Analyzer Algorithm Server (ALS) receives an audio file as input and returns an analysis result of positive or negative regarding whether a wheeze was detected as output.
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- The TytoCare Lung Sounds Analyzer Web Server (WBS) provides a graphic indication whether a wheeze is detected in the recording. It can be utilized both in patient and clinician side.
All the software subsystems (servers and storage) are hosted in the cloud and communicate through IP network.
Here's a breakdown of the acceptance criteria and the study details for the TytoCare Lung Sounds Analyzer, based on the provided document:
Acceptance Criteria and Device Performance
| Parameter | Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|---|
| Sensitivity (Se) | Not explicitly stated as a target | 0.69 (0.57–0.78) (95% CI) |
| Specificity (Sp) | Not explicitly stated as a target | 0.92 (0.88–0.95) (95% CI) |
| Overall Accuracy | Non-inferior to clinical readers | AUC = 0.91 (0.86-0.94) |
| Non-Inferiority | Non-inferiority margin of 5% (0.05) | Difference in AUC = 0.09 (0.04-0.13) which supports noninferiority (0.04 > -0.05) |
| Reproducibility | Not explicitly stated as a target | Kappa for device: 1.00 (1.00-1.00) vs. Clinical Readers: 0.6134 (0.5183-0.7016) |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: 371 recordings (86 Wheeze positive, 285 negative) from 359 patients.
- Data Provenance: Retrospective validation dataset of Tyto Stethoscope recordings sourced from real-world use of the Tyto Care FDA cleared Tyto Stethoscope. The dataset included recordings from patients with known pre-existing conditions (COPD or Asthma) (7.28%).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Three.
- Qualifications: Blinded experienced Pulmonologists. Specific years of experience are not mentioned.
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Adjudication method for the test set:
- Adjudication Method: Majority vote of the three blinded Pulmonologists ("binary ground truth was determined by majority vote of these three Pulmonologists"). This is a 3-reader consensus method.
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If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- Yes, a comparative study was done. The clinical performance section compares the device's AUC to that of "clinical readers (Physicians non-Pulmonologists)."
- Effect size of how much human readers improve with AI vs. without AI assistance: The study primarily focused on the device's accuracy being non-inferior to human readers, rather than human readers with AI assistance. The reported AUC for the device (0.91) was higher than the AUC for clinical readers (0.83), with a difference of 0.09. This suggests the device performs better than the un-assisted clinical readers. The study did not test human readers with AI assistance, so an effect size for human improvement with AI assistance cannot be determined from this document.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone accuracy assessment was performed. Table 3 explicitly presents "The stand-alone accuracy of the TytoCare Lung Sounds Analyzer" with sensitivity and specificity results.
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The type of ground truth used:
- Type of Ground Truth: Expert consensus. Specifically, a majority vote of three blinded experienced Pulmonologists.
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The sample size for the training set:
- The document does not provide the sample size for the training set. It only mentions the validation dataset.
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How the ground truth for the training set was established:
- The document does not provide information on how the ground truth for the training set was established. It only describes the ground truth establishment for the validation dataset.
§ 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).