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The AeroEclipse* ONE BAN is intended to be used with adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

The subject device. AeroEclipse* ONE BAN (Breath Actuated Nebulizer) is a jet nebulizer intended to administer medication (prescribed by a physician or health care provider) in the form of an aerosol for patient inhalation. It operates in conjunction with a compressed air source and a liquid medication. The subject device is designed to produce and deliver aerosolized medication only during the patient inspiratory cycle, thus significantly reducing fugitive emissions to the environment. It can be used in hospitals, clinics and in the home. Liquid medication is placed in the medication cup of the nebulizer bottom, into which the nebulizer top sub-assembly is attached. The air supply tubing provides the interface for the pressurized air. Aerosol is inhaled by the patient via the oral interface of the mouthpiece. As the patient inhales, ambient air travels down through the nebulizer, creating a pressure drop which causes the actuator, connected to the diaphragm to move down into the nebulizing position. As inhalation continues, aerosol is created and inhaled through the mouthpiece. When inhalation ceases, the actuator returns to the up position thereby eliminating the pressure drop which leads to the device discontinuing the creation of an aerosol. As the patient inhales through the mouthpiece, the actuator drops, and the creation of aerosol begins again. The overall device is comprised of a nebulizer bottom with nozzle feature, a nebulizer top sub-assembly, a mouthpiece and air supply tubing.

The provided document is a 510(k) premarket notification for a medical device, specifically a nebulizer (AeroEclipse* ONE BAN). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study involving AI or human readers.

Therefore, the document does not contain the information requested regarding:

• Acceptance Criteria for an AI-powered device: This document is for a mechanical nebulizer, not an AI device.
• Study proving device meets acceptance criteria: There is no AI performance study described.
• Sample sizes for test sets, data provenance, expert ground truth establishment, or adjudication methods: These details are specific to AI model validation, not mechanical device testing.
• MRMC comparative effectiveness study or standalone AI performance: Not applicable to this type of device submission.
• Training set information for an AI model: No AI model is being submitted.

Instead, the document details physical performance testing (aerosol characterization, design verification), biocompatibility, and dry gas pathway testing to ensure the safety and effectiveness of the nebulizer. The primary objective is to show that the new device is "substantially equivalent" to an already cleared predicate device.

Key relevant points from the document regarding its performance evaluation:

1. Device Type: AeroEclipse* ONE BAN (Breath Actuated Nebulizer) - a mechanical device for administering aerosolized medication.
2. Performance Data:
   • Aerosol Characterization: Performed in accordance with CDRH Guidance Document "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH - 1993). Results "demonstrated substantially equivalent in-vitro performance" to the predicate device.
   • Design Verification Testing: Included Flow Performance, Drop Testing, Environmental Testing, and Life Cycle Testing. Results "demonstrate the subject device... meets the requirements outlined in the design verification plan."
   • Biocompatibility Testing: Not performed, as materials are identical to the cleared predicate device.
   • Dry Gas Pathway Testing: Included assessments for volatile organic compounds (VOCs), fine particles (PM2.5), and inorganic gases (ozone, CO2, CO) per ISO 18562. "Testing results and risk assessment demonstrated that exposure during use is unlikely to result in toxicological effects."
3. Clinical Performance Summary: "Not applicable. The determination of substantial equivalence is not based on Clinical Performance data."

In summary, this document is for a traditional medical device and does not involve AI or the associated acceptance criteria and study designs you've inquired about.

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