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510(k) Data Aggregation
(266 days)
AIRSOFT F15
The AirSoft F15 is a noninvasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as continuous positive airway pressure (CPAP) or bilevel system.
The AirSoft F15 is:
• to be used by patients (weighing >66 lb (30 kg)) for whom positive airway pressure therapy has been prescribed
• intended for single-patient reuse in the home environment and multipatient reuse in the hospital/institutional environment.
The AirSoft F15 Mask system is an externally placed mask covering the mouth and the nose of the patient. It provides a seal such that positive pressure from a positive pressure source is directed to the patient's nose and/or mouth. It is held in place with an adjustable headgear that straps the mask to the face.
AirSoft F15 can be cleaned by the patient in the home environment and reprocessed by professionals in the hospital/institutional environment.
AirSoft F15 is intended to be used under the conditions and purposes indicated in the labelling provided with the product.
AirSoft F15 is a prescription device supplied non-sterile.
The provided text is a 510(k) summary for the ResMed AirSoft F15, a vented full-face mask. It describes the device, its intended use, and a comparison to predicate devices, focusing on non-clinical performance data to demonstrate substantial equivalence.
Here's the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a separate section. Instead, the performance evaluations are broadly stated as demonstrating "substantial equivalence" to predicate devices. The key performance areas evaluated and their outcomes are:
| Performance Area | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Pressure-Flow Characteristics & Flow Impedance | Identical to predicate device (Quattro Air) in labelled performance range. | Identical to predicate devices. |
| CO2 Washout Performance (Physical & Functional Dead Space) | Substantially equivalent to predicate device (Ultra Mirage FFM). Adequate venting to flush out expired CO2. | Substantially equivalent to predicate devices. |
| Biocompatibility | Complies with ISO 10993-1, -3, -5, -6, -10 and FDA guidance #G95-1 for materials in contact with patient/gas pathway. | Evaluated for genotoxicity, cytotoxicity, implantation, sensitization, and irritation. Implied compliance. |
| Mechanical Integrity & Performance | Withstands normal use and reasonable abuse scenarios, storage temperature, humidity, and transportation shock & vibration. | Tested and confirmed to withstand these conditions. |
| Cleaning & Reuse Validation | Maintained intended function after validated disinfection protocols and indicated number of cycles for single-patient home reuse and multi-patient hospital/institutional reuse. | Confirmed to continue functioning as intended. |
| Overall Substantial Equivalence | Same intended use, similar technological and performance characteristics as predicates. | Substantially equivalent to nominated predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" and its sample size in the context of clinical trials or human subject testing. The performance data presented appears to be derived from non-clinical bench testing. The data provenance is not explicitly stated beyond being "extensive testing performed." It is implied to be internal testing conducted by ResMed Ltd in Australia ("ResMed Ltd, 1 Elizabeth Macarthur Drive, Bella Vista NSW 2153 Australia"). The data is retrospective in the sense that it was collected and analyzed to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the evaluations were primarily non-clinical bench tests and did not involve a test set requiring expert-established ground truth in the context of medical image interpretation or clinical outcomes. The "ground truth" for these engineering tests would be derived from physical measurements and established engineering standards.
4. Adjudication Method for the Test Set
This information is not applicable as the performance evaluations were non-clinical bench tests and did not involve human interpretation or a need for adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Use of Full Face masks with CPAP or Bilevel therapy equipment is proven technology and is well accepted by the medical community. So was the case for the predicate devices, bench testing was sufficient to demonstrate substantial equivalence to the predicate devices."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This question is not applicable to this device. The ResMed AirSoft F15 is a physical medical device (a mask), not an AI algorithm. Therefore, "standalone" performance in the context of AI is not relevant.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" was established through:
- Engineering and physical measurements: For pressure-flow characteristics, flow impedance, CO2 washout, mechanical integrity.
- ISO standards and FDA guidance: For biocompatibility evaluations (e.g., ISO 10993-1, FDA guidance #G95-1).
- Validated protocols: For cleaning and reuse validation.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical mask and does not involve a training set as would be used for an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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