(39 days)
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
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Equivalence (Pressure) | Statistical equivalence of vest pressure output between modified and predicate device when predicate controls are adjusted to match the modified device's settings (fixed frequency: 13 Hz, fixed pressure: dial setting 6). | A paired t-test on 15 vest pressure comparisons (using 5 standard size vests) yielded a calculated t-value of 0.34. This is "well within the t critical value for statistical equivalence with an alpha of .05 of ± 2.145," indicating statistical equivalence. |
| Safety Standard Compliance | Compliance with UL 544, "Standard for Safety" for Medical and Dental Equipment (same standard as predicate). | The modified Vest System is listed to UL 544. |
| Electromagnetic Compatibility (EMC) | Compliance with FCC Part 15 testing. | The modified Vest system passed FCC Part 15 testing. |
| European EMC/Electrical Safety Standard | Compliance with European Standard EN 60601-1-2 testing. | The modified Vest system passed European Standard EN 60601-1-2 testing. |
| Physical Characteristics (Dimensions/Weight) | Overall dimensions or weight of the modified device should be the same as the predicate. | The overall dimensions or weight of the modified device is the same as the predicate. |
| Component Compatibility | The vest components used with the modified system should be the same as those used with the predicate device. | The vest components that are used with the modified Vest System is the same as the vests used with the predicate device. |
| Indications for Use Equivalence | The intended use and indications for use of the modified device must be the same as the predicate device, as described by the American Association for Respiratory Care (AARC) Clinical Practice Guideline (1991). | The intended use of the modified Vest™ Airway Clearance System is the same as the predicate device. Indications include promoting airway clearance/improving bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician's choice, particularly for retained secretions, difficulty with secretion clearance, or atelectasis caused by mucus plugging. Also indicated for collecting mucus for diagnostic evaluation. |
Study Details (Applicable to this 510(k) submission)
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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.
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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.
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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.
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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.
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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.
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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.
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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."
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How the ground truth for the training set was established:
- Not applicable. As no training set was involved for an AI model.
§ 868.5665 Powered percussor.
(a)
Identification. A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.(b)
Classification. Class II (performance standards).