(14 days)
1 - Intended Use: The DHD TRUST is intended for use as a nebulizer.
- 2 Indications:
- The DHD TRUST provides additional hydration to help loosen secretions for patients whom extended therapy is required.
- The DHD TRUST delivers aerosolized medications and diagnostic formulations.
- 3 Target Patient Population
Patients with asthma, pneumonia, COPD, or any other condition in which appropriate medications would be nebulized.
The DHD TRUST is indicated for use as a single patient use nebulizer. TRUST is a small plastic device that threads onto a regulated flow meter supplying air or oxygen. A reservoir bottle threads to the bottom of TRUST to hold water and/or medication. Trust has a secondary port on the side of the device to allow for supplemental air, oxygen, or heliox.
The provided text describes a 510(k) premarket notification for the DHD Healthcare Corporation's "TRUST" nebulizer. It details the device's intended use, technological characteristics, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm or software. The study mentioned relates to particle size delivery for a physical medical device (nebulizer) and aims to show equivalence to a predicate device, not performance benchmarks for an AI system.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance for an AI/ML device, nor can I discuss sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided document.
The "Summary of Studies" section only states:
"Testing of particle size delivery was performed in accordance with the guidance document "REVIEWER GUIDANCE FOR NEBULIZERS, METERED DOSE INHALERS, SPACERS AND ACTUATORS". The results of this testing shows particle size delivery to be equivalent between TRUST and the predicate."
This describes a physical performance test for a nebulizer, not an AI/ML model.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).