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The Aeroneb Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.

The Aeroneb Go nebulizer uses the OnQ™ Aerosol Generator, which is comprised of a unique dome shaped aperture plate containing over 1,000 precision-formed tapered holes surrounded by a vibrational element. When energy is applied, the aperture plate vibrates approximately 100,000 times per second. This rapid vibration causes each aperture to act as a micropump, drawing liquid through the holes to form consistently sized droplets. The Aeroneb Go nebulizer is lightweight, compact and silent. The device can be powered with the AC Power Controller or with the Battery Powered Controller that uses three "AA" disposable batteries.

Here's an analysis of the provided text regarding the Aeroneb Go Nebulizer, matching the requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list "acceptance criteria" with specific quantitative thresholds. Instead, it states that performance evaluations were conducted and demonstrated "substantial equivalence" to predicate devices. The performance evaluations focused on "nebulizer delivery characterization, electrical, mechanical, and EMC safety."

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

The document refers to "non-clinical performance tests." It does not specify a sample size for the test set. It also does not provide information about the data provenance (e.g., country of origin, retrospective/prospective), as these were non-clinical, likely bench tests.

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

This section is not applicable. The verification did not involve human interpretation or expert-established ground truth in the way a diagnostic imaging study would. The performance was assessed against technical specifications and comparison to predicate devices.

4. Adjudication Method for the Test Set

This section is not applicable. There was no need for adjudication as the testing involved objective measurements and comparisons to predicate device performance.

5. 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

This section is not applicable. The device is a nebulizer, not an AI-assisted diagnostic tool.

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

This section is applicable in the sense that the device's performance was assessed independently of human interaction for its core function (aerosolizing solutions). The "standalone" performance is the focus of the non-clinical tests.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation was established by:

• Technical specifications/design parameters: The device was tested to ensure it performed consistently within its intended design.
• Comparison to predicate devices: The performance metrics (likely particle size distribution, nebulization rate, etc.) were compared against those of already-approved predicate nebulizers. The FDA guidance for nebulizers (October 1, 1993) also likely served as a reference for expected performance characteristics.

8. The Sample Size for the Training Set

This section is not applicable as this is not an AI/machine learning device that requires a training set.

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

This section is not applicable as this is not an AI/machine learning device that requires a training set.

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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

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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The AeroNeb™ II Portable Nebulizer is intended for breath-triggered nebulization of aerosolized medications prescribed by a physician.

The AeroNeb™ II is a battery operated hand-held portable nebulizer using the same materials and piezoelectric vibration aerosol generator technology as the predicate device.

The provided text describes the AeroNeb™ II Portable Nebulizer and aspects of its 510(k) premarket notification. However, it does not contain the detailed information necessary to fully answer all the questions regarding acceptance criteria and the study that proves the device meets them.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document states: "The performance evaluations including nebulizer delivery characterization, electrical, and EMC safety, were based on those suggested in the FDA CDRH - REVIEWER GUIDANCE FOR NEBULIZERS, METERED DOSE INHALERS, SPACERS AND ACTUATORS issued on: October 1, 1993." and "The successful tests demonstrated the device consistently performed within its design parameters, is as safe and effective, and performs as well as, or better than, the predicate device."

This indicates that specific performance evaluations were conducted, but the acceptance criteria values and the actual reported device performance values are not detailed in this summary. These would typically be found in the full submission, not a general 510(k) summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is a nebulizer, not a diagnostic imaging device. Therefore, the concept of "ground truth" derived from expert consensus, as typically applied in AI/ML performance studies, is not applicable here. The performance is assessed through objective engineering and safety tests (nebulizer delivery characterization, electrical, and EMC safety).

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

As mentioned above, the concept of "adjudication" for expert consensus is not applicable for this type of device testing.

5. 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

This is a physical medical device (nebulizer), not an AI/ML diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.

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

This is a physical medical device (nebulizer), not an algorithm. Therefore, "standalone" algorithm performance is not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For this device, the "ground truth" or standard of comparison is based on:

• FDA CDRH - REVIEWER GUIDANCE FOR NEBULIZERS, METERED DOSE INHALERS, SPACERS AND ACTUATORS issued on: October 1, 1993.
• Comparison to the predicate device (FPT Nebulizer K970010), demonstrating it is "as safe and effective, and performs as well as, or better than" the predicate.

8. The sample size for the training set

This is a physical medical device. The concept of a "training set" as understood in machine learning is not applicable. Device development involves design, prototyping, and testing, but not a "training set" in the computational sense.

9. How the ground truth for the training set was established

Again, the concept of "training set" and "ground truth for the training set" is not applicable to this type of device. Performance is validated against established physical and electrical standards, and comparison to a legally marketed predicate device.

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