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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 Velox Nebulizer System is a handheld nebulizer that is to be used with patients for whom doctors have prescribed medication for nebulization. It is intended for adult and pediatric patients 4 years and older who can coordinate breathing through a mouthpiece, and may be used in hospital-type facilities, nursing homes, sub-acute institutions and home environments.

The Velox Nebulizer System is a portable, reusable, single-patient use, handheld electronic nebulizer that uses a piezo-driven, micro-perforated vibrating membrane technology to aerosolize liquid medications for the treatment or prophylaxis of respiratory diseases. It is to be used with adult and pediatric patients for whom doctors have prescribed medication, i.e. it is for prescription use only. It may be used in hospital-type facilities, nursing homes, sub-acute institutions and home environments. It is provided non-sterile. The device consists of two major components: the nebulizer and a Controller. The nebulizer contains a medication cap, medication reservoir, aerosol head, aerosol chamber, and mouthpiece. The Controller contains a circuit board, USB connector, patient interface (on/off switch), and AA battery housing. The controller's functions are to conduct power pre-processing, supervise aerosol generation through incorporated software, and generate optical and acoustical feedback to the user. The device is powered by connection to a mains power source via an AC Power Supply or disposable/rechargeable AA batteries. Associated accessories include a cleaning aid and an AC Power Supply.

The provided text describes the regulatory clearance of a medical device (Velox Nebulizer System) and does not contain information about an AI/ML powered device. Therefore, it is impossible to extract the requested information regarding acceptance criteria and study details for an AI/ML powered device.

The document is a 510(k) premarket notification for a nebulizer, a physical medical device. The "Software Verification and Validation Testing" section mentions that the software for this device is of a "moderate" level of concern and controls basic functions of the nebulizer (power, aerosol generation, user feedback) but there is no indication that it uses AI or machine learning algorithms for its operation or for diagnostic purposes.

Therefore, I cannot provide the detailed information requested for an AI/ML powered device, such as effect size of human readers improving with AI, standalone performance, or details about ground truth establishment for AI/ML models.

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