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510(k) Data Aggregation
(191 days)
AF541 EE Full Face Mask
AF541 EE Leak 1 Mask
This Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>40lbs/20kg) for whom CPAP or bi-level therapy has been prescribed.
AF541 EE Leak 2 Mask
This Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single use in the hospital/institutional environment and single patient use in the home. The mask is to be used on patients (>40lbs/20kg) for whom CPAP or bi-level therapy has been prescribed.
The AF541 EE Full Face Mask is an oral-nasal full face mask that is available in various configurations (cushions and elbows). The AF541 EE Full Face has two cushion configurations, an Over the Nose (OTN) cushion and an Under the Nose (UTN) cushion. The following elbow configurations are available: EE Leak 1 and EE Leak 2. The Leak 1 and Leak 2 elbows have an anti-asphyxia valve. In addition, the Leak 2 elbow has built in exhalation to provide intentional leak when needed.
The AF541 EE Full Face Mask will have interchangeable cushions that attach to a common frame. There will be four sizes available for the nose option (S, M, L, XL). The UTN option will have three sizes available (A, B, C).
The AF541 mask will include a 4-point headgear and capstrap to allow for oral access with either headgear option. There will be 22 mm female mask frame. The AF541 OTN and UTN will be compatible with the EE Leak 1 and EE Leak 2 elbow.
The provided text is a 510(k) Summary for the AF541 EE Full Face Mask. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance and biocompatibility testing, rather than extensive clinical studies as seen with novel medical devices or AI-driven diagnostics.
Therefore, many of the requested categories related to clinical studies, AI performance, ground truth, and expert evaluation are not applicable or detailed in this document. The information available focuses on engineering and material performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Design verification tests were performed on the AF541 EE Full Face Mask. All tests were verified to meet the required acceptance criteria." However, it does not explicitly list specific numerical acceptance criteria for each performance test. It only lists the tests performed and implicitly confirms that the device met the (unspecified) acceptance criteria.
| Performance Test Category | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance |
|---|---|---|
| Total Mask Pressure Drop | Not explicitly stated | Met required acceptance criteria |
| Total Mask Leak | Not explicitly stated | Met required acceptance criteria |
| Intentional Leak | Not explicitly stated | Met required acceptance criteria |
| Inspiratory & Expiratory Anti-Asphyxia Feature Resistance | Not explicitly stated | Met required acceptance criteria |
| Anti-Asphyxia Feature Close to Atmosphere | Not explicitly stated | Met required acceptance criteria |
| Anti-Asphyxia Feature Open To Atmosphere | Not explicitly stated | Met required acceptance criteria |
| Dead space | Not explicitly stated | Met required acceptance criteria |
| CO2 Rebreathing | Not explicitly stated (Note: ISO 17510-2 Clause 5.3 on protection against rebreathing is listed as a deviation, so this likely indicates efforts to address it) | Met required acceptance criteria |
| Storage Temperature and Humidity | Not explicitly stated | Met required acceptance criteria |
| Cleaning Validation | Not explicitly stated | Met required acceptance criteria |
| Biocompatibility Tests | Acceptable biological response/safety | All completed tests showed acceptable results |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data or clinical imaging. The tests performed are engineering-focused on the device itself.
- Sample Size for performance testing: Not specified. It refers to the physical device being tested.
- Data Provenance: The nature of the tests (engineering performance, biocompatibility) implies laboratory testing of the device and its materials, not patient data from a specific country or retrospective/prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for engineering performance tests is typically established by engineering standards and specifications, not expert clinical consensus.
4. Adjudication Method for the Test Set
Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, which are not detailed for these engineering tests.
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: "Clinical tests were not required to demonstrate the substantial equivalence of the AF541 EE Full Face Mask. Product functionality has been adequately assessed by non-clinical tests."
This device is a face mask, not an AI diagnostic tool that would typically undergo such a study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a medical mask, not an algorithm or software.
7. The Type of Ground Truth Used
For the performance tests, the "ground truth" would be the established engineering and safety standards (e.g., ISO specifications) to which the device was compared.
For biocompatibility, the ground truth is the absence of adverse biological reactions as defined by toxicology and material science standards (e.g., ISO 10993-1).
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set for this device.
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