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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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The Enchant AllPEP is intended for use as a Positive Expiratory Pressure (PEP) by patients aged 18 years and older. Patients must be capable of generating an exhalation flow of 10 lpm for 3-4 seconds to promote secretion clearance. This device may be used to prevent or reverse atelectasis and as an inspiratory, deep breathing positive exerciser. It may be used in hospital and clinical settings.

AllPEP provides PEEP during user exhalation and features a mechanism which provides oscillations during exhalation as well.

Principle of Operation: The oscillating positive exhalation pressure device, AllPEP, includes a housing, a top cover, and an oscillating mechanism. The patient inhales room air through a one-way valve and when exhaling the exhaled gas is directed through the upper portion of the device which contains a swinger mechanism to oscillate the air, causing the air to vibrate.

The provided text is a 510(k) premarket notification FDA review letter for the "AllPEP" device, classified as an Incentive Spirometer. It addresses the substantial equivalence of the AllPEP device to a predicate device, DHD Acapella K991561.

The document details the device's indications for use, patient population, environment of use, and a comparison of its features and performance to the predicate device. Crucially, it highlights non-clinical bench testing as the primary method to demonstrate substantial equivalence, rather than clinical studies involving human participants or MRMC studies.

Therefore, the following is a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria based only on the information provided in the document.

Acceptance Criteria and Device Performance for AllPEP

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • The document describes non-clinical bench testing and biocompatibility testing. It does not specify sample sizes for these tests (e.g., number of devices tested for aging, cleaning, or performance metrics).
   • Data Provenance: The tests are performed by the sponsor, Enchant Tek Co. Ltd., based in Taiwan. The data provenance is from bench testing (laboratory-controlled conditions) rather than clinical data from human subjects. The document does not specify if the testing was retrospective or prospective, but bench testing is typically considered prospective for the device being submitted.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This submission relies on bench testing and biocompatibility test results, which compare device performance to pre-defined engineering and safety standards, and to a predicate device's characteristics. There is no mention of human expert-based ground truth establishment as would be relevant for a diagnostic AI device or clinical study.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. No human readers or "ground truth" establishment by experts is described for this type of submission. The performance is gauged against pre-defined engineering specifications and comparison to the predicate device's established characteristics.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is a submission for a Positive Expiratory Pressure (PEP) device, which is a mechanical therapeutic device, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant or described.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is not an algorithm or AI. It is a physical medical device. The "standalone" performance testing refers to the device's intrinsic mechanical performance (frequency, amplitude, pressure) as measured during bench tests.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" (or basis for acceptance) for this device is established through:
     • Pre-defined engineering and performance specifications based on the device's intended function and regulatory standards for incentive spirometers.
     • Comparison to the performance characteristics of a legally marketed predicate device (DHD Acapella K991561) to establish substantial equivalence.
     • International standards (ISO 10993-series and ISO 18562-series) for biocompatibility testing.
   • There is no medical "ground truth" (like disease presence from pathology or outcomes) as this is not a diagnostic device.

7. The sample size for the training set:

   • Not applicable. This device is not an AI or machine learning product, so there is no concept of a "training set" for an algorithm.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set for an algorithm, there is no ground truth established for one.

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