(77 days)
AirPhysio is indicated for use as a Positive Expiratory Pressure (PEP) Device for improving the clearance of mucus secretions from the airways.
AirPhysio vibrates the airway walls to assist in loosening mucus and intermittently increases endobronchial pressure so that the airway patency can be maintained during exhalation, reducing the potential of mucus becoming trapped as it moves up the airways.
The device may also be useful in the removal of mucus from patients who have chronic bronchitis or bronchiectasis and in conjunction with a medical need for positive expiratory pressure (PEP) therapy.
AirPhysio is a small, handheld expiration resistance device, consisting of a hardened plastic mouthpiece at one end, a plastic cover with an opening at the other end, and a valve on the inside created by a high- density stainless-steel ball resting in a plastic conical cone. Exhalation through the device causes vibrations, assisting to loosen mucus from the airways. The resistance is increased by tilting the device.
The subject device is provided non-sterile for reprocessing in a home environment and has no accessories or configuration options.
The provided document is a 510(k) premarket notification for the AirPhysio Positive Expiratory Pressure (PEP) Device. It focuses on demonstrating substantial equivalence to a predicate device (Flutter D - Clement Clarke - K972859) rather than establishing novel acceptance criteria for a new type of device or conducting a performance study against a predefined clinical endpoint.
Therefore, the document does not contain the information required to populate all the sections of acceptance criteria and study details as requested. Specifically, it does not outline a clinical study with quantifiable acceptance criteria for a new device, a defined test set of patient data, expert ground truth establishment for medical images, MRMC studies, or standalone algorithm performance.
However, based on the information provided, here's what can be extracted and inferred regarding the "acceptance criteria" through the lens of substantial equivalence and the "study" conducted for AirPhysio:
Acceptance Criteria for Substantial Equivalence (Inferred from regulatory context)
For devices seeking 510(k) clearance, the "acceptance criteria" are typically demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing that it has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The performance tests conducted are to support this demonstration of similarity.
Table of Acceptance Criteria and Reported Device Performance (Inferred/Extracted from the document)
| Acceptance Criteria (Demonstrated Equivalence to Predicate) | Reported Device Performance (AirPhysio) |
|---|---|
| Biocompatibility: No cytotoxic, sensitization, or irritation effects. | Passed: Biocompatibility evaluation on 9 complete assemblies (in accordance with FDA ISO 10993-1) concluded no cytotoxic effects, no sensitization reactions, and no irritation (based on erythema and edema scores). Contact type: Surface device (exhalation only), Contact Duration: Permanent Exposure (>30 days). |
| Reprocessing Effectiveness/Safety: Sufficiently clean and hygienic after reprocessing. | Passed: Independent laboratory tests verified that when reprocessing guidelines are followed, AirPhysio is sufficiently clean, hygienic, and as safe to use as the legally marketed predicate device. |
| Functional Performance (Bench Testing): Comparable performance characteristics (Mean PEP, Peak PEP, Amplitude PEP, Oscillation Frequency) across different flow rates. | Passed: Comparative bench testing showed AirPhysio and predicate device have comparable characteristics and substantially similar output specifications. Bland Altman Analysis performed to support equivalence. |
| Usability/Human Factors: Safe and effective use by target users in the intended environment, without adverse risks. | Passed: Usability testing demonstrated the device is safe and effective for intended use, users, and environments. Followed FDA's "Applying Human Factors and Usability Engineering to Medical Devices" (Feb 3, 2016) guidance. |
| Intended Use Equivalence: Same indications for use as the predicate device. | Demonstrated: Indicated for use as a Positive Expiratory Pressure (PEP) Device for improving the clearance of mucus secretions from the airways, vibrating airway walls to loosen mucus, maintaining airway patency during exhalation, and reducing mucus trapping. Also useful for chronic bronchitis/bronchiectasis with medical need for PEP therapy. |
| Technological Characteristics Equivalence: Similar design principles (pipe-like shape, metal ball, cone, mouthpiece, vented cover), same operating principles (OPEP, PEP generation). | Demonstrated: Based on same technological characteristics (pipe-like shape, metal ball, cone, mouthpiece, vented cover). Operates on same principles: oscillating high frequency PEP (OPEP), generating PEP with a moveable steel ball that opposes exhalation, causing vibrations to loosen mucus. |
| Contraindication Equivalence: Similar contraindications. | Demonstrated: AirPhysio's contraindications largely align with the predicate, including pneumothorax, tuberculosis, haemoptysis, right-sided heart failure (with added oesophageal surgery and middle ear pathology). |
Study Details (as presented in the document):
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Sample size used for the test set and the data provenance:
- Biocompatibility: 9 complete assemblies. Data provenance not explicitly stated, but implied to be laboratory testing for regulatory submission.
- Reprocessing: Not specified, but involved independent laboratory tests.
- Comparative Bench Testing: Not specified, but involved comparing "the AirPhysio device with the legally marketed predicate across different flow rates." This typically involves a range of controlled in-vitro conditions.
- Usability Testing: Not specified for the number of participants, but it's human factors validation testing involving the "target user population." Data provenance not explicitly stated (e.g., country of origin), assumed to be for regulatory submission.
- Note: This is not a clinical study on patient data but rather engineering and human factors testing on the device itself or typical users.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth here is the performance of the predicate device and established engineering/biocompatibility standards, not clinical labeling by expert readers of medical images.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring reader adjudication of clinical data.
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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:
- No MRMC study was conducted. This device is a mechanical PEP device, not an AI-powered diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical medical device, not an algorithm. Bench testing evaluates the "standalone" performance of the mechanical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Biocompatibility: Established international standards (e.g., ISO 10993-1) and in-vitro testing results (cellular response, skin reactions).
- For Reprocessing: Established hygiene and safety standards, verified by independent lab.
- For Functional Performance: Performance characteristics (Mean PEP, Peak PEP, Amplitude PEP, Oscillation Frequency) of the predicate device served as the performance target/ground truth for comparison. Bench test measurements against engineering specifications.
- For Usability: FDA human factors guidance and user interaction studies to ensure safe and effective operation based on predefined tasks and risk analysis.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device requiring a training set. The device is mechanical.
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How the ground truth for the training set was established:
- Not applicable.
§ 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).