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ProChamber™ Valved Holding Chamber is intended for use in combination with Metered Dose Inhalers (MDI's) to assist in respiratory drug delivery. All patients using MDI's, i.e., children and adults, may use ProChamber ™. Settings for use include the home, clinics and hospitals.

This device is intended for prescription use.

The device consists of an MDI Adapter, a Chamber, a Mouthpiece, a Duckbill Valve, an Exhaust Valve and a Silicone Cap. There are no electrical or electronic components.

Here's a breakdown of the acceptance criteria and study information for the ProChamber™ Valved Holding Chamber, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a numerical sample size for the "particle size distribution testing." It simply states "ProChamber ™ and the predicate device, the AeroChamber Plus™ , were tested for particle size distribution testing."

The data provenance is also not explicitly stated in terms of country of origin. The test was a non-clinical test performed according to the methodology outlined in the FDA "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators, 10/93." This suggests it was a laboratory-based study, not involving human subjects.

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

Not applicable. This device underwent non-clinical testing (particle size distribution) rather than clinical studies requiring expert ground truth for interpretation of patient data.

4. Adjudication Method for the Test Set:

Not applicable. There was no clinical trial or testing that would require an adjudication method. The evaluation was based on objective physical measurements (particle size distribution).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size:

No. A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission explicitly states "Discussion of Clinical Tests Performed: Not applicable." The evaluation was based on non-clinical, laboratory testing.

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

Not applicable. This device is a physical medical device (valved holding chamber for MDIs), not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm does not apply. The device's performance was evaluated inherently "standalone" in a laboratory setting in terms of its physical properties.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical testing was based on objective physical measurements of particle size distribution, compared against established guidelines (FDA "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators, 10/93") and comparison to the predicate device.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" for its development.

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

Not applicable, as there was no training set.

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This nebulizer compressor is an AC-powered air compressor intended to provide a source of compressed air for medical purposes for use in home health care. This device is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders such as asthma, allergies, COPD, etc.

This line-powered piston compressor is housed in a plastic cabinet (case). Dimensions are 7.3 in. x 6.9 in. x 4.0 in. and weighs 3.3 lbs. It consists of a motor-driven piston compressor, an in-line fuse, and a switch; it contains no microprocessors or other electronic components. It operates from 115 VAC, 60 Hz. It is supplied with tubing, an instruction manual, and a 510(k) cleared nebulizer.

In use, the compressor is placed on a flat surface and the nebulizer tubing is connected to the hose barb. The unit is then turned on. Inlet air to the compressor passes through a replaceable filter.

The provided text describes the acceptance criteria and the study conducted for the Mister Neb™ Nebulizer Compressor, Model HS123. However, it's important to note that this device is a medical compressor and not an AI-powered device. Therefore, several of the requested categories (like MRMC study, effect size of AI, standalone algorithm performance, and details about training sets) are not applicable.

Here's the information based on the provided text:

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

2. Sample size used for the test set and the data provenance

The document does not specify a distinct "test set" in the context of data or a medical imaging device. The testing was performed on "device sample(s)" of the Mister Neb™ Nebulizer Compressor. The provenance is the testing conducted internally by Respironics HealthScan, Inc. as part of their submission to the FDA. The tests were non-clinical, evaluating the physical and electrical safety and performance of the device itself.

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

Not applicable. This device is a mechanical compressor, not an AI or diagnostic device that requires expert ground truth for interpretation of medical data. The ground truth for the performance was established by adherence to specified engineering and safety standards.

4. Adjudication method for the test set

Not applicable. There was no "adjudication" in the sense of reconciling multiple expert opinions for diagnostic labels or interpretations. The testing involved measuring physical properties and adherence to established engineering standards.

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

Not applicable. This device is a mechanical nebulizer compressor, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a mechanical nebulizer compressor and does not have an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance was the adherence to established engineering, safety, and electromagnetic compatibility (EMC) standards and guidelines, specifically:

• FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND (outlining Electrical, Mechanical, and Environmental Performance Requirements).
• CISPR 11 for Radiated and Conducted Emission.
• MIL-STD-462D, Method RE101 for Magnetic Field Emission.
• Reviewer Guidance document for Fast Surges.
• FDA's DCRND "Reviewer Guidance for Home Use Respiratory Devices".

8. The sample size for the training set

Not applicable. This device is a mechanical nebulizer compressor and does not involve machine learning algorithms or training data.

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

Not applicable. No training set was used.

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