(267 days)
Aerosure is indicated for use as a Positive Expiratory Pressure (PEP) Device.
- · The use of Aerosure improves clearance of secretions
- · The use of Aerosure may reduce the need for postural drainage
- Aerosure facilitates opening of airways in patients with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems
- · Aerosure may be used to prevent or reverse atelectasis
· Aerosure may also be useful in the removal of mucus from the lungs of patients who have chronic bronchitis or bronchiectasis
Aerosure is intended for patients age 21 and above with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis. All patients must be capable of following instructions for Positive Expiratory Pressure Therapy.
Aerosure may be used in hospital as well as the home after a period of training.
Aerosure is a small, battery powered device. It produces a rapidly alternating occlusion of airflow as a user breathes through the replaceable valve head (containing the powered rotating vane mechanism) which creates a general increase in resistance to breathing and a vibration of the respiratory tree and the associated structures, including the musculature. Frequency is adjusted by switching modes.
The provided document is a 510(k) summary for the Aerosure Medic device. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for clinical performance.
Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment cannot be directly extracted from this document.
However, I can provide the available information based on what is presented:
Acceptance Criteria and Reported Device Performance
The document states that a variety of performance tests were conducted, and the device "functioned as intended" and "met its specifications." It also notes that performance bench test data demonstrated the Aerosure Medic is "substantially equivalent" to predicate devices and has "directly comparable basic characteristics and substantially similar output specifications." Crucially, it highlights that human factors and usability testing concluded the device is "reasonably safe and effective for the intended users, uses and use environments."
General Acceptance Criteria (Implied / Stated):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993) | Functioned as intended; results observed were as expected. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Functioned as intended; results observed were as expected. |
| Medical Device Safety (IEC 60601-1) | Functioned as intended; results observed were as expected. |
| Cleaning Instructions Support | Cleaning and ingress protection testing demonstrated that reasonably expected cleaning would not affect performance or safety; no depreciation in performance or safety. |
| Ingress Protection (IP45 [IEC60529]) | Testing verified no water ingress and normal device function after exposure to expected in-use water exposure. |
| Functional Testing | Demonstrated the Aerosure Medic device met its specifications. |
| Bench Testing (vs. Predicates) | Showed directly comparable basic characteristics and substantially similar output specifications to predicate devices. |
| Usability Testing / Human Factors | Concluded that Aerosure Medic is reasonably safe and effective for the intended users, uses, and use environments, following FDA's human factors draft guidance. |
Missing Information (Not Present in the Document):
Due to the nature of this 510(k) summary, the following specific details are not provided:
- Sample size used for the test set and the data provenance: The document mentions "performance data," "functional testing," "bench testing," and "usability testing," but it does not specify sample sizes for any of these tests or the data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed clinical performance results and ground truth establishment involving human experts are not described in this regulatory submission for substantial equivalence.
- Adjudication method for the test set: Not applicable for the type of testing described (which is primarily bench, safety, and usability).
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device, and no MRMC study or AI components are mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm-only device; it's a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the tests described would be objective measures against engineering specifications, safety standards, and usability criteria. There is no mention of clinical ground truth (like pathology or outcomes) as a basis for device performance in this submission.
- The sample size for the training set: Not applicable, as this is not a machine learned AI device.
- How the ground truth for the training set was established: Not applicable.
Summary of Study Information (Based on Document):
- Type of Studies: Biocompatibility, Electromagnetic Compatibility, Medical Device Safety, Cleaning & Ingress Protection, Functional Testing, Bench Testing (comparison to predicates), and Usability/Human Factors Testing.
- Purpose of Studies: To demonstrate that the Aerosure Medic "functioned as intended," "met its specifications," is "substantially equivalent" to predicate devices, and is "reasonably safe and effective" for its intended users and uses.
- Methodology for Usability Testing: Followed FDA's human factors draft guidance for industry entitled, "Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011)."
The document primarily serves to demonstrate that the Aerosure Medic's technological characteristics and performance are substantially equivalent to existing, legally marketed predicate devices, thereby supporting its 510(k) clearance for marketing.
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).