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Airmod, when used in conjunction with Accursound Electronic Stethoscope AS-101, is a software as medical device intended to be used for the continuous, non-invasive monitoring of respiratory rate (RR) in adult patients who are subjected to procedural sedation and/or anesthesia.

Airmod is intended for use by healthcare professionals in hospitals and healthcare facilities who are legally credentialed to perform procedural sedation and/or anesthesia.

Airmod is intended for Android-based devices only.

Airmod 114 is an Android-based software application designed to aid healthcare professionals by monitoring a sedated and/or anesthetized patient's breathing in real time. The device has an AIbased algorithm that can detect inhalation acoustics and provides respiratory rates based on the analysis of the acoustic signals of breathing sounds collected by AccurSound Electronic Stethoscope AS-101. Airmodid for the continuous monitoring of respiratory rate (RR) in adults who are subjected to procedural sedation. Airmod™ is designed for use in hospitals and healthcare facilities performing procedural sedation/anesthesia. The device is not intended for patients who are not anesthetized/sedated.

Here's a breakdown of the acceptance criteria and study details for the Airmod device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

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The AS-101 is an electronic stethoscope intended for the detection and amplification of sounds associated with the heart, lungs, arteries, veins, and other internal organs. It can be used on any person undergoing a physical assessment. The device is intended to be operated only by healthcare professionals for diagnostic decision support in clinical settings.

This submission is for device "The AccurSound Electronic Stethoscope AS-101 ("AS-101")". This submission expands upon a previously 510(k)-cleared device(K221805) by introducing two new reusable sensors, whereas the original device only included disposable sensors..

The AccurSound Electronic Stethoscope AS-101 ("AS-101") in this submission is a device designed for healthcare professionals used in clinical settings. The AS-101 can detect and amplify the sounds of the heart, lungs, arteries, veins, and other internal organs.

The microphone-equipped sensor detects and amplifies the sounds from the patient's body. The auscultation sound is digitally processed and filtered, electronically amplified in the hub unit. The anti-noise function reduces ambient noise and echoes, then transferred to the earpiece.

The multi-channel design allows healthcare professionals to attach disposable sensors or reusable sensors onto patient's body, by switching modes from handheld single-channel recording to four-channel stationery and continuously auscultation based on different requirements of clinical applications or physical assessments.

The provided text is a 510(k) Premarket Notification for the AccurSound Electronic Stethoscope (AS101), which is a modification of a previously cleared device (K221805). The modification involves the introduction of two new reusable sensors, whereas the original device only included disposable sensors. Based on the document, here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of acceptance criteria with corresponding performance results for specific clinical metrics. Instead, it relies on non-clinical testing and the substantial equivalence to the predicate device. The performance tests mentioned are general and not detailed with specific quantitative acceptance criteria in this document.

However, based on the information provided, the following non-clinical tests were conducted to ensure safety and performance:

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

The document explicitly states: "This submission does NOT include animal or clinical performance testing." Therefore, there is no clinical test set, sample size, or data provenance (country of origin, retrospective/prospective) to report for the primary evaluation of this device (the modified AS-101 with reusable sensors). The assessment relies on non-clinical bench testing and the substantial equivalence to the predicate device.

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

As there was no clinical study conducted for this submission (specifically for the modified device), there is no information on experts used to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable as there was no clinical test set.

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

No MRMC comparative effectiveness study was done. The document states: "This submission does NOT include animal or clinical performance testing."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is an electronic stethoscope intended for use by healthcare professionals for direct patient assessment, not an AI algorithm acting in a standalone capacity. The "diagnosis decision support" refers to the device aiding the human professional, not replacing them or offering an automated diagnosis.

7. Type of Ground Truth Used

For the non-clinical tests conducted, the "ground truth" would be established by the industry standards and regulatory requirements themselves (e.g., passing specific electrical safety thresholds, demonstrating biocompatibility as per ISO standards, software functioning as specified). There is no "ground truth" in the sense of clinical reference diagnoses (e.g., pathology, outcomes data, expert consensus) because no clinical performance testing was performed for this submission.

8. Sample Size for the Training Set

Not applicable. The AccurSound Electronic Stethoscope is a hardware device for sound amplification and filtering. It does not appear to incorporate machine learning or AI that would require a "training set" in the conventional sense of AI/ML algorithms. The software mentioned is for device control and processing, verified through standard software validation, not through learning from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned or implied.

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The AS-101 is an electronic stethoscope intended for the detection of sounds associated with the heart, lungs, arteries, veins, and other internal organs. It can be used on any person undergoing a physical assessment. The device is intended to be operated only by healthcare professionals for diagnostic decision support in clinical settings.

The AccurSound Electronic Stethoscope AS-101 ("AS-101") is a device designed for healthcare professionals used in clinical settings. The AS-101 can detect and amplify the sounds of the heart, lungs, arteries, veins, and other internal organs.

The microphone-equipped disposable sensor detects and amplifies the sounds from the patient's body. The auscultation sound is digitally processed and filtered, electronically amplified in the hub unit. The anti-noise function reduces ambient noise and echoes, then transferred to the earpiece.

The multi-channel design allows healthcare professionals to attach disposable sensors onto patient's body, by switching modes from handheld single-channel recording to four-channel stationery and continuously auscultation based on different requirements of clinical applications or physical assessments.

The associated accessories include:

• Disposable sensor(s)
• Patient cable(s)
• Earphone
• Power adapter with power cord

The provided text is a 510(k) Premarket Notification for the AccurSound Electronic Stethoscope AS-101. It describes the device, its intended use, and compares it to a predicate device (3M Littmann Electronic Stethoscope, Model 3200).

However, the document explicitly states that this submission "does NOT include animal or clinical performance testing" and focuses solely on non-clinical (bench) testing. This means the document does not contain information about studies involving human subjects to assess clinical performance or comparative effectiveness with human readers.

Therefore, I cannot provide information for several of your requested points, as they pertain to clinical studies, AI performance studies, or human expert consensus, which are not detailed in this 510(k) summary.

Here's what I can extract and address based on the provided text:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):

Since no clinical study data is provided, the "acceptance criteria" discussed are for the device's engineering performance and safety, rather than clinical efficacy or diagnostic accuracy.

Regarding the other requested information:

• Sample sizes used for the test set and the data provenance: Not applicable. No clinical test set. The non-clinical tests would have their own sample sizes (e.g., number of devices tested), but this is not detailed for each specific test in the summary.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or human expert review.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication.
• 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. This device is an electronic stethoscope and is not an AI-assisted diagnostic tool in the typical sense that would involve interpretative reading and MRMC studies. The document explicitly states "This submission does NOT include animal or clinical performance testing."
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electronic stethoscope intended for human use, not a standalone diagnostic algorithm.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" would be established engineering specifications and recognized safety standards.
• The sample size for the training set: Not applicable. This document is for a medical device (electronic stethoscope), not an AI/machine learning algorithm that would have a "training set."
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and compliance with relevant safety and performance standards, rather than clinical performance studies or AI validation.

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