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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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The intended use of the Advanced Respiratory 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. The Advanced Respiratory modified 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 modified Vest™ Airway Clearance System is a high-frequency chest wall oscillator for enhancing the mobilization of bronchial secretions. The device is designed for use in applications where patients are unable to manually operate the device output functions, e.g. organ donor procurement centers. The primary components of the Advanced Respiratory modified Vest™ Airway Clearance System include an air-pulse generator, an inflatable vest and connecting tubing. 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 donor patient creating high-frequency chest wall oscillation that results in the mobilization of bronchial secretions. The air output pulses are set at a fixed frequency (13 Hertz) and pressure (equal to a dial setting of 6 on the predicate device).

The provided document describes a 510(k) premarket notification for a modified medical device, the Modified Vest™ Airway Clearance System. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a previously legally marketed device (predicate device), not necessarily to prove absolute efficacy or performance of the device in a clinical setting through extensive studies meeting rigorous acceptance criteria often associated with AI/software devices.

Therefore, the information requested might not be fully available or directly applicable in the format expected for AI/software-based medical devices or typical performance studies. I will extract what is available and highlight where information is missing or not applicable to this type of regulatory submission.

Acceptance Criteria and Device Performance

The "acceptance criteria" in this context is the concept of substantial equivalence to the predicate device. The performance testing aimed to demonstrate that the modifications did not negatively impact the device's safety and effectiveness compared to the predicate, and that when set to comparable parameters, their performance was equivalent.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Applicable to this 510(k) submission)

1. Sample size used for the test set and the data provenance:

   • Sample Size: 15 vest pressure comparisons were performed, using all 5 of the standard size vests.
   • Data Provenance: Not explicitly stated, but clinical studies for de novo approval are usually associated with specific sites. For a 510(k) demonstrating equivalence, it's likely internal lab testing or a controlled environment. The document is from Advanced Respiratory, located in Minnesota, USA, suggesting a US-centric provenance for the testing. It is a prospective comparison test of the modified device against the predicate.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This document describes a physical device comparison, not an expert-driven ground truth assessment for a diagnostic or AI algorithm. Therefore, "experts" in the sense of clinical reviewers establishing ground truth are not applicable. The ground truth was based on objective physical measurements (pressure output) and compliance with established engineering and safety standards.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on challenging cases, typically in diagnostic imaging or clinical assessments where ground truth is subjective or requires expert interpretation. This study involved objective physical measurements and engineering compliance.

4. 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 a physical medical device (high-frequency chest wall oscillator), not an AI/software diagnostic tool, and it does not involve human "readers" or AI assistance in interpretation. No MRMC study was conducted.

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

   • Partially applicable/Re-interpreted: The "standalone" performance here refers to the device's ability to maintain its specified physical parameters (frequency and pressure output) and comply with safety standards. The document states the modified device's air output pulses are "set at a fixed frequency (13 Hertz) and pressure (equal to a dial setting of 6 on the predicate device)." The performance testing then verified this output against the predicate device when the predicate was similarly adjusted. So, the device's own output was tested. This is not "algorithm only" in the AI sense, but rather "device only" performance.

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

   • The "ground truth" for this submission was based on objective physical measurements (vest pressure output, frequency settings), engineering specifications, and adherence to established safety and electrical standards (UL 544, FCC Part 15, EN 60601-1-2). The comparison was to the predicate device's measured performance under matching conditions.

7. The sample size for the training set:

   • Not applicable. This is a physical device undergoing modification and substantial equivalence demonstration, not an AI model that requires a "training set."

8. How the ground truth for the training set was established:

   • Not applicable. As no training set was involved for an AI model.

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