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AllNEB Breath Actuated Nebulizer is intended for adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed healthcare provider or physician. AllNEB is intended for the administration of aerosolized medication prescribed by a physician or healthcare professional. AllNEB is to be used at home or in hospitals and clinics.

AllNEB 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, reducing fugitive emissions to the environment. It can be used in hospitals, clinics and in the home.

This document is a 510(k) clearance letter for a medical device called "AllNEB Breath Actuated Nebulizer." It demonstrates the device's substantial equivalence to a legally marketed predicate device, the AeroEclipse II Breath Actuated Nebulizer (K053605).

The core of the acceptance criteria and proof revolves around comparative performance testing, showing that the AllNEB device performs similarly to the predicate device across various aerosolization metrics.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly derived from the performance of the predicate device. The goal is to demonstrate "substantial equivalence," meaning the new device performs similarly to the predicate. The performance of the predicate device, AeroEclipse II Breath Actuated Nebulizer (K053605), serves as the "acceptance criteria," and the "Reported Device Performance" is that of the AllNEB device.

The tables provided in the 510(k) summary (pages 7-16) present a direct comparison of various aerosolization parameters for both the AllNEB (Subject Device) and the AeroEclipse II (Predicate Device) under different conditions (Breath Actuated Mode, Constant-Output Mode, Adult settings, Pediatric settings, and Simulated Breathing).

Key Performance Metrics (Acceptance Criteria are inferred to be "similar to predicate"):

• MMAD (Mass Median Aerodynamic Diameter): A measure of the central tendency of the particle size distribution.
• GSD (Geometric Standard Deviation): A measure of the spread or variability of the particle size distribution.
• Total Dose Delivered: The total amount of medication delivered by the nebulizer.
• Total Respirable Dose (0.5-5 µm): The amount of medication delivered as particles within the respirable range (able to reach the lower respiratory tract).
• Coarse Particle Dose (>4.7 µm): The amount of medication delivered as larger particles.
• Fine Particle Dose (<4.7 µm): The amount of medication delivered as smaller particles.
• Ultra-Fine Particle Dose (<1.0 µm): The amount of medication delivered as very small particles.

Example Excerpt from the Tables (Acceptance Criteria vs. Reported Performance):

(Self-Correction: The "Similar" comment applies to all comparative data points presented in the submission, indicating that the observed differences were deemed acceptable for substantial equivalence for all the data points included in these tables.)

The acceptance criterion for each measured value is that the AllNEB device's performance is "similar" to that of the predicate device. The tables, consistently marked with "Similar" in the comment column, indicate that this criterion was met for all tested parameters and conditions.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the sample size (e.g., number of nebulizers tested, number of runs per nebulizer) used for the comparative performance testing. It presents the mean values for various measurements. The typical practice for such in vitro performance testing of nebulizer devices would involve multiple repetitions to ensure reproducibility and statistical validity, but the exact N is not given here.

The data provenance is also not explicitly stated regarding the country of origin or whether it was retrospective or prospective. However, given that this is a 510(k) submission for a new device, the performance testing would undoubtedly be prospective and conducted by the manufacturer (Enchant Tek Co. Ltd.) as part of their pre-market submission requirements. The location of the sponsor (Taipei, TW) suggests the testing likely occurred in Taiwan or through a contract research organization.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This document describes the performance testing of a physical medical device (nebulizer) based on in vitro aerosolization characteristics, not a diagnostic AI/ML algorithm that requires expert adjudication of medical images or patient data.

Therefore, the concept of "experts used to establish the ground truth" in the sense of medical professionals (e.g., radiologists, pathologists) is not applicable here. The "ground truth" for the performance data is established by the methods and equipment used for aerosol particle sizing and dose measurement (e.g., cascade impactors, spectrophotometry), which are standard industry practices and governed by international standards (e.g., ISO 27427 for nebulizing systems). The "experts" would be the engineers and technicians proficient in running these highly standardized tests.

4. Adjudication Method for the Test Set

As explained above, since this is a performance test for a physical device, not an AI/ML diagnostic system based on human interpretation, an "adjudication method" (like 2+1 or 3+1 reviewer consensus for image reads) is not applicable. The data are quantitative measurements obtained through standardized laboratory procedures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not conducted. This type of study is typically performed for diagnostic devices (especially those involving interpretation of medical images or signals) to assess how human performance (e.g., accuracy, efficiency) changes with and without AI assistance. The AllNEB is a drug delivery device, not a diagnostic tool requiring human interpretation of output.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not Applicable. This question is relevant for AI/ML devices where the algorithm's performance can be evaluated independently. The AllNEB is a mechanical device, and its performance is inherently "standalone" in terms of its aerosolization characteristics (it functions as designed regardless of a human interface beyond its intended use).

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by physical measurements and testing using standardized laboratory equipment and methods. These methods quantitatively assess:

• Particle size distribution (MMAD, GSD)
• Drug delivery efficiency (Total Dose Delivered, Respirable Dose, etc.)

These measurements are considered the objective "ground truth" for the device's physical performance characteristics. The comparison is made against the results obtained with the predicate device using the same methodologies.

8. The Sample Size for the Training Set

Not Applicable. This device is a mechanical nebulizer, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set for a mechanical device, there is no ground truth to be established for it.

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