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The AirFit F20 is a non-invasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous pressure (CPAP) or bilevel system.

The AirFit F20 is:

• to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure therapy has been prescribed
• intended for single-patient reuse in the home environment and multi-patient reuse in the hospital/institutional environment.

The AirFit F20 is an externally placed vented mask covering the mouth and the nose of the patient. It provides a seal such that pressure from a positive pressure source is directed to the patient's nose and/or mouth. The mask connects via a standard conical connector to a conventional air delivery hose, which in turn connects to the positive pressure source. The mask is held in place with an adjustable headgear that straps the mask to the face.

The AirFit F20 mask system comprises four subassemblies: cushion, frame, elbow and headgear. The elbow incorporates the vent array and anti-asphyxia valve safety features. The cushion and headgear are available in various sizes to fit a wide patient population.

AirFit F20 is a prescription device supplied non-sterile.

This document is an FDA 510(k) clearance letter for a medical device called AirFit F20, a non-invasive accessory for positive airway pressure (PAP) devices. It does not contain information about an AI/ML device or a study involving human readers and AI assistance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance using AI, as the provided text pertains to a traditional medical device submission and does not involve AI or ML.

The document discusses the substantial equivalence of the AirFit F20 to a previously cleared predicate device (AirFit F20 (K153563)) based on:

• Intended Use: Same
• Operating Principle: Same
• Design and Materials: Similar
• Performance: Similar pressure-flow characteristics and flow impedance
• Operating Environments: Same (home and hospital/institution)
• Manufacturing Processes: Similar

The main differences from the predicate device relate to reprocessing claims for multi-patient reuse and material changes to certain components. Non-clinical data validation testing was conducted to demonstrate that these changes do not raise new questions of safety or effectiveness. This validation included:

• Bioburden efficacy tests
• Performance tests (visual inspection, total mask flow, AAV activation/deactivation, assembly integrity, mask-to-headgear connections) before and after reprocessing
• Residual toxicity tests
• Biocompatibility tests for material changes (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Acute systemic toxicity, Material-mediated Pyrogenicity, Implantation, Leachables testing)

In summary, the provided text describes a 510(k) clearance for a non-AI medical device and therefore does not contain the information needed to answer your specific questions about AI acceptance criteria and study details.

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