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The Vest® Airway Clearance Systems is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice or treatment. Indications for this form of therapy are described by the American Association of Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy. According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Vest® Airway Clearance System is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for the purposes of collecting mucus for diagnostic evaluation.

The Vest® Airway Clearance System consists of an inflatable garment attached to an Air Pulse Generator that rapidly inflates and deflates the inflatable garment. This causes the chest wall to be gently compressed and released, which creates airflow within the lungs. This process moves the mucus toward the large airways where it can be cleared by coughing or suctioning. This type of Airway Clearance Therapy is referred to as High Frequency Chest Wall Oscillation (HFCWO).

The system consists of an Air Pulse Generator, connecting hose, and multiple styles and sizes of garments. The garments are single patient, multi-use.

The provided text is a 510(k) Summary for the Hill-Rom "The Vest® Airway Clearance Systems (Model 105)". This document states that the new device is substantially equivalent to a previously cleared predicate device (K024309) and therefore does not include a study demonstrating the new device meets specific acceptance criteria based on clinical outcomes or performance metrics like accuracy, sensitivity, or specificity. Instead, the focus is on comparative non-clinical bench testing to prove equivalence.

Therefore, much of the requested information, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets, is not applicable in the context of this 510(k) submission as it relies on substantial equivalence to a predicate device rather than novel performance demonstration.

However, I can extract the information provided regarding the testing performed to support substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim based on non-clinical testing rather than clinical performance metrics, the "acceptance criteria" here refer to the successful completion and comparison of non-clinical tests to demonstrate that modifications do not raise new safety or effectiveness concerns compared to the predicate device.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "comparative non-clinical bench testing." The tests performed are listed in the table above and in the "Non-clinical Testing Summary" section of the 510(k) summary (page 6 of the document). These tests were conducted to demonstrate that the updated device, with its minor modifications, performs equivalently to the predicate device and does not introduce new safety or effectiveness risks.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable to this 510(k) submission. The document describes non-clinical bench testing, which typically does not involve human sample sizes or data provenance in the same way clinical studies do. The testing involved comparing the proposed device components (Air Pulse Generator, connecting hose, garments) with the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The ground truth for this type of non-clinical bench testing is based on engineering specifications and compliance with established standards, not expert clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the testing is non-clinical bench testing against engineering standards.

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

This information is not applicable. The device is an airway clearance system, not an AI-powered diagnostic device, and therefore MRMC studies are not relevant to its clearance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. The device is a physical medical device, not an algorithm, so standalone performance in this context is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission are the established engineering specifications and international standards (e.g., IEC 60601-1, FCC Part 15B, etc.) that the device must meet, and the performance characteristics of the predicate device (K024309), which the new device aims to be substantially equivalent to.

8. The sample size for the training set

This information is not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this type of device submission.

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The intended use of the Modified Vest™ Airway Clearance System is the same as the predicate device, which is to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Vest™ Airway Clearance System is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.

The Advanced Respiratory Vest™ Airway Clearance System is a high-frequency chest wall oscillator designed to be used in a wide variety of settings for enhancing the mobilization of bronchial secretions. The primary components of The Vest™ Airway Clearance System include an air-pulse generator and an inflatable vest. Oscillating positive pressure air pulses are applied to the vest by the air-pulse generator. The resulting pressure pulses cause the vest to inflate and deflate against the chest of the user creating high-frequency chest wall oscillation and mobilization of bronchial secretions.

Here's a breakdown of the acceptance criteria and the study details for the Modified Vest™ Airway Clearance System based on the provided K024309 submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

This submission does not specify a test set sample size or data provenance in terms of country of origin or retrospective/prospective nature. The "Performance Testing" section describes a comparison to a predicate device rather than a clinical study with a distinct test set.

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

Not applicable. The submission does not detail a clinical study with a test set requiring expert-established ground truth. The evaluation is based on functional and performance comparison to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a test set or an adjudication method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly performed or referenced in this document. The submission focuses on substantial equivalence based on technical and functional comparisons to predicate devices, not on a clinical trial with human readers and AI assistance.

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

No standalone performance study of an algorithm without human-in-the-loop performance was conducted or described, as this device is a physical medical device (Powered Percussor) and not an AI/software-as-a-medical-device. The "performance testing" described is for the device itself against a predicate device.

7. Type of Ground Truth Used

The "ground truth" in this context is the established functionality and performance of the predicate devices (The Vest™ Vest System, K012928, and K993629). The new device's performance is gauged against the known characteristics and approved indications for use of these existing, legally marketed devices.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device (Powered Percussor), not an AI/machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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