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The AdheResp Smart Breath-actuated Mesh Nebulizer is a system to aerosolize liquid medications for inhalation for patients ranging from pediatrics equal to or greater than 5 years old to adults who can coordinate breathing.

The environment of use are Hospital/institutional settings, home care use, schools, and long-term care facilities.

The AdheResp Smart Breath-actuated Mesh Nebulizer consists of a main unit, medication reservoir, mouthpiece, key tag and charging cable, or power adapter. The medication reservoir could be further separated into a medication container and an aerosol chamber.

Principle of Operation: There are two key features in the AdheResp Smart Breath-actuated Mesh Nebulizer, which are vibrating mesh nebulization and breath-actuation functions. The AdheResp Smart Breath-actuated Mesh Nebulizer is an active mesh nebulizer. Active mesh nebulizers operate by electrically activating a piezoelectric (PZT) ceramic element that rapidly contracts and expands when applied a voltage to it. The vibrations of the PZT are transmitted to the mesh membrane, which is in contact with the liquid medication loaded in the medication container. This vibration pushes the liquid or suspension through the fine conical holes of the mesh, forming aerosol droplets for the user to inhale.

This document is a 510(k) clearance letter for the AdheResp Smart Breath-actuated Mesh Nebulizer. It outlines the device's characteristics and its equivalence to predicate devices, particularly focusing on performance data related to aerosol delivery.

Here’s the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: The provided text is a 510(k) summary and clearance letter. It summarizes findings and states that acceptance criteria were met, but it does not provide the detailed study protocols, raw data, or the explicit acceptance criteria values themselves in a direct, quantifiable manner for all aspects. Instead, it presents comparative performance data and lists categories of testing. Therefore, some information will be inferred from the context or noted as 'not explicitly stated' if the document does not provide it.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for each parameter in a "limit" vs. "result" format. Instead, it presents comparative performance data against a predicate device and states that the subject device "met its acceptance criteria" and that its performance is "similar." For the purpose of this table, I will present the reported performance of the Subject Device and mention the comparison to the Predicate. The implicit acceptance criterion for the comparative performance data is that the subject device's performance is demonstrably non-inferior or similar to the predicate.

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

• Sample Size for Test Set:
  • For the comparative performance testing (Breath Actuated Particle Characterization): "Testing was performed with 3 samples of each device in triplicate with the 3 drugs." This implies $3 \text{ devices} \times 3 \text{ replicates} = 9$ runs per drug per flow rate for both the subject and predicate devices.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is non-clinical bench testing ("Bench testing," "Non-Clinical Testing Summary"), meaning it's a controlled lab environment, not patient data. It is a prospective study in the sense that the tests were conducted specifically for this submission.

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

• Number of Experts: Not applicable. This device is a nebulizer, and the tests described are bench tests (e.g., particle size, dosage, flow rates). These are physical measurements, not interpretations of medical images or patient conditions that would require expert human readers to establish ground truth.
• Qualifications of Experts: N/A, as noted above.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is not a study involving human interpretation of data, where adjudication of disagreements would be necessary. The performance data is derived from direct and repeatable physical measurements.

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

• MRMC Study: No. An MRMC study is typically performed for AI/CADe (Computer-Assisted Detection/Diagnosis) devices that assist human readers in interpreting medical images. This device is a nebulizer, a drug delivery system, and its performance is evaluated through bench testing.

• Effect Size of Human Readers' Improvement: Not applicable, as no MRMC study was performed.

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

• Standalone Performance: Yes, in essence. The "AdheResp Smart Breath-actuated Mesh Nebulizer" itself has an algorithm for "Breath Actuation" that "Measures breath and averages the cycle, then delivers aerosol during the designated period." The "Breathe Actuated Particle Characterization Performance Comparison" is a standalone evaluation of the device's physical output based on this internal algorithm responding to simulated breathing patterns (15 LPM and 30 LPM). There is no "human-in-the-loop" for the output of the device itself.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device's performance is established by standardized laboratory measurements using traceable equipment and protocols (e.g., measuring particle size, drug quantity, flow rates) under controlled conditions. This is considered an objective physical truth, not a subjective interpretation. The comparison is made against a legally marketed predicate device's performance.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a physical medical device (nebulizer) with an embedded algorithm, not a machine learning/AI model that requires a "training set" of data in the typical sense for image recognition or diagnostic purposes. The device's "algorithm" is for controlling the nebulization based on breath patterns, which would be developed through engineering and control system design, not data-driven machine learning.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" in the context of a machine learning model. The "ground truth" for the device's operational parameters (like breath-actuation logic or aerosol delivery range) would be based on established engineering principles, physiological understanding of human breathing, and clinical requirements for drug delivery, validated through rigorous bench testing and potentially human factors testing, though the latter is not detailed in this summary.

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The Pulmogine® Vibrating Mesh Nebulizer is a system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital / institutional settings, home care use, schools, and long-term care facilities.

The Pulmogine® Vibrating Mesh Nebulizer, whose dimensions are 74 mm (L) x 46 mm (W) x 96 mm (H), is a small, dumbbell-shaped, handheld, and internally powered general-purpose nebulizer which utilizes vibrating mesh technology to generate aerosol. The Pulmogine® Vibrating Mesh Nebulizer is designed for a single patient, multiple uses, and mainly composed of a Main Unit and a Medication Reservoir.

The Main Unit contains the control circuitry and the firmware to control the vibrating mesh module in the Medication Reservoir and is powered by 2 AA alkaline batteries or an AC adaptor.

The Medication Reservoir contains the nebulizing module (mesh) where the liquid medication will be turned into aerosols. The prescribed medication is added into the reservoir with ten (10) ml of medication capacity, nebulized, and inhaled through the aerosol port.

The Pulmogine® Vibrating Mesh Nebulizer generates aerosol from liquid medication during turning on through pressing ON/OFF button and turning off when pressing ON/OFF button again, auto-turn off when no liquid detected, or 10-minute session completed. There are different LED lights to monitor the status and operating condition of the nebulizer: green indicates power on and normally working, yellow flash indicates low power caution, and constant yellow indicates shut-off due to too low power.

The provided text describes a 510(k) premarket notification for the Pulmogine® Vibrating Mesh Nebulizer. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing the detailed acceptance criteria and a study proving those criteria are met for a novel AI/ML device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI/ML device is not available in the provided text.

The document primarily describes:

• Device: Pulmogine® Vibrating Mesh Nebulizer
• Purpose: Aerosolize liquid medications for inhalation.
• Target Population: Pediatric (5 years and older) and adult patients.
• Setting: Hospital/institutional, home care, schools, long-term care facilities.
• Classification: Class II Nebulizer.
• Predicate Device: Omron Micro Air Vibrating Mesh Nebulizer, Model NE-U22 (K062263).

The "performance test" section (page 5) mentions that the final products must demonstrate comparable aerosol characteristics to the predicate device at adult and pediatric flow rates. These characteristics include:

• Delivered dose (ug)
• Mass median aerodynamic diameter / MMAD (um)
• Geometric standard deviation / GSD
• Total respirable dose (0.5-5um)
• Coarse particle dose (> 4.7um)
• Fine particle dose (

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