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510(k) Data Aggregation
(33 days)
AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000
The Aeroneb® Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation and other positive pressure breathing assistance. The Aeroneb Pro is suitable for use in adult and pediatric patients as described in the Instruction Manual.
The Aeroneb® Professional Nebulizer System is a multiple patient reusable pulmonary drug delivery system that incorporates Aerogen's proprietary aerosol generator technology for continuous nebulization of drugs to patients. The Aeroneb Pro is designed to be used with mechanical ventilators and pressurized breathing systems as well as by spontaneously breathing patients. It is intended for multiple patient use and is autoclavable. The nebulizer can be placed in the inspiratory limb of a ventilator circuit or used with a mask or mouthpiece. The Aeroneb Pro operates without changing patient ventilatory parameters, can be refilled without interrupting ventilation, and can be powered by AC/DC adapter or internal rechargeable battery. Because the Aeroneb Pro operates without compressed gas and can be battery-powered, it is also suitable for use during patient transport.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Aeroneb® Professional Nebulizer System, structured to answer your questions.
Device: Aeroneb® Professional Nebulizer System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance within design parameters (safety and effectiveness) | "demonstrated the device consistently performed within its design parameters" |
| As safe and effective as predicate devices | "is as safe and effective, and performs as well as, or better than, the predicate devices" |
| Conformance to FDA CDRH - REVIEWER GUIDANCE FOR NEBULIZERS, METERED DOSE INHALERS, SPACERS AND ACTUATORS (Oct 1, 1993) | "Evaluation of performance included nebulizer delivery characterization, electrical, mechanical, and EMC safety, were based on those suggested in the FDA CDRH - REVIEWER GUIDANCE..." |
| Substantial equivalence to predicate devices | "The Aeroneb Pro is substantially equivalent to similar features in the predicate devices and has the same intended use and technological characteristics as the predicate devices." |
Note: The provided text outlines performance evaluations rather than specific, quantifiable acceptance criteria with numerical targets. The "acceptance criteria" are implied to be achieving performance that is at least as good as, and preferably better than, the predicate devices, while adhering to relevant FDA guidance and design parameters.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature). It only mentions "Non-clinical performance tests were conducted."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention human experts or ground truth establishment in the context of device performance testing. The "performance evaluations" described are non-clinical, focusing on the device's physical and functional characteristics rather than an assessment of human interpretation or diagnosis.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method. This is expected as the evaluations were non-clinical performance tests, not human-in-the-loop assessments requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The performance evaluations were non-clinical and focused on the device itself, not human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence, a standalone performance evaluation was done. The described "Performance evaluations" (nebulizer delivery characterization, electrical, mechanical, and EMC safety) are all assessments of the device's inherent performance, independent of human interaction or interpretation beyond its operation. The device itself is not an AI algorithm, but the evaluation methods used are analogous to a standalone performance assessment for a physical medical device.
7. The Type of Ground Truth Used
The ground truth for the performance evaluations was based on engineering and performance metrics related to nebulization delivery, electrical and mechanical safety, and electromagnetic compatibility (EMC). This would involve:
- Measurement of physical parameters: e.g., aerosol particle size, drug delivery rate, power consumption, mechanical integrity.
- Compliance with standards: e.g., electrical safety standards, EMC standards.
- Comparison to predicate device performance: Using the established performance of the predicate devices as a benchmark for "as safe and effective" or "better than."
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device and its evaluation. This is a physical medical device, not an AI or machine learning algorithm that requires a training set for model development.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for this physical device, this question is not applicable.
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