(191 days)
This Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alams and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory insufficiency or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.
The AF541 SE Full Face Mask is an oral-nasal full face mask that is available in two cushion configurations. The AF541 SE Full Face has two cushion configurations, an Over the Nose (OTN) cushion and an Under the Nose (UTN) cushion. The AF541 SE Full Face Mask will have interchangeable cushions that attach to a common frame. There will be four sizes available for the over the nose option (S, M, L, XL). The UTN option will have three sizes available (A, B, C). The AF541 SE will include a 4 point headgear and capstrap to allow for oral access with either headgear option.
The provided text is a 510(k) Summary for a medical device called the "AF541 SE Full Face Mask." This type of document is for demonstrating substantial equivalence to a predicate device, not for proving that a device meets specific clinical performance acceptance criteria in the way an AI diagnostic device would.
Therefore, the document does not contain the information requested in your prompt regarding:
- A table of acceptance criteria and reported device performance for an AI model.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, or standalone performance for an AI model.
- Ground truth details for test or training sets of an AI model.
The document describes non-clinical performance and biocompatibility tests for a physical medical device (a mask) and compares it to a predicate device.
However, to address some elements from your prompt based on the provided text, and distinguish them from what is not present (AI-specific criteria):
Acceptance Criteria and Device Performance (Non-Clinical for a Physical Mask Device):
The document states that "Design verification tests were performed on the AF541 SE Full Face Mask. All tests were verified to meet the required acceptance criteria." It also notes that "Performance testing was performed before and after cleaning treatments to verify that the device modifications did not raise new safety and effectiveness concerns of the subject device."
The specific acceptance criteria values or the reported performance data are not provided in this summary. It only states that the tests met the required acceptance criteria.
Types of Non-Clinical Performance Testing Performed:
- Total Mask Pressure Drop: The device was tested to ensure the pressure drop across the mask meets certain specifications for proper ventilation. (Specific criteria/results not provided).
- Total Mask Leak: The device was tested for leakage to ensure effective delivery of ventilatory pressure. (Specific criteria/results not provided).
- Deadspace: The dead space within the mask was measured to ensure it is within acceptable limits for effective ventilation. (Specific criteria/results not provided).
Biocompatibility Testing (for materials in contact with tissue):
New materials used in the mask were classified as external communicating, tissue contact, with a contact duration C (> 30 days cumulative). The following biocompatibility tests were completed and presumably met their acceptance criteria:
- Muscle Implantation Study in Rabbits (4 Weeks)
- Muscle Implantation Study in Rabbits (12 Weeks)
- Genotoxicity: Bacterial Reverse Mutation Study
- Genotoxicity: Mouse Lymphoma Assay
- Genotoxicity: Mouse Peripheral Blood Micronucleus Study
- Intracutaneous Injection Test
- Kligman Maximization Test
- Agar Diffusion Test (Direct Contact)
Regarding the AI-specific questions from your prompt:
- Table of acceptance criteria and the reported device performance: Not applicable/Not present. This document is for a physical medical device (mask), not an AI diagnostic/analytic device. It states non-clinical tests met acceptance criteria, but no specific values or a table are provided.
- Sample size used for the test set and the data provenance: Not applicable/Not present. No test set for an AI model.
- Number of experts used to establish the ground truth... and qualifications: Not applicable/Not present. No ground truth for an AI model.
- Adjudication method: Not applicable/Not present. No adjudication method for an AI model.
- If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable/Not present. No MRMC study for an AI model.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not present. No algorithm performance.
- The type of ground truth used: Not applicable/Not present.
- The sample size for the training set: Not applicable/Not present.
- How the ground truth for the training set was established: Not applicable/Not present.
Conclusion from the document:
The manufacturer concluded that the new AF541 SE Full Face Mask is substantially equivalent to the predicate device (AF531 SE Full Face Mask - K101129) based on similar intended use, operating principle, design, materials (with biocompatibility testing for new materials), and manufacturing process, and that non-clinical performance and design verification tests (Total Mask Pressure Drop, Total Mask Leak, Deadspace) were successfully met, raising no new safety or effectiveness concerns. Clinical tests were explicitly stated as "not required."
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).