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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, etc.

This piston-driven nebulizer contains vents in the two sides and bottom of the case providing ventilation for the motor. The compressor has only one control a double pole toggle switch to turn the compressor on and off. The unit has a two-wire power cord with polarized plug, an internal fuse, and no exposed metal that is likely to become energized (two screws that hold the case together are greatly recessed on the bottom surface and are not likely to become energized). In use, the compressor is placed on a flat surface and the cover is opened to reveal an outlet hose barb to which the oxygen (air) delivery tubing and nebulizer are connected. Inlet air to the compressor passes through a replaceable filter.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the John Bunn Neb-U-Lite II™ Medication Compressor:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states, "None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was CITECH's conclusion that the John Bunn Neb-U-Lite II™ Medication Compressor with Disposable Nebulizer, Model #JBO-112-009 device sample tested met all relevant requirements..."

• Sample Size: The exact number of units tested is not specified, but it refers to a "device sample." This typically implies a small, representative number of production units.
• Data Provenance: The testing was conducted by CITECH, an external testing laboratory. The country of origin is not explicitly stated, but the submission is to the FDA, implying the data would be accepted within a US regulatory context. The testing described is prospective in nature, as it involves physical and electrical testing of the newly manufactured device.

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

This information is not provided in the document. The tests described are primarily engineering and performance tests against established standards and guidelines, not clinical evaluations requiring expert interpretation of patient data.

4. Adjudication Method for the Test Set:

This information is not applicable as the tests are non-clinical, objective measurements against pre-defined engineering standards established by organizations like UL, DCRND, and IEC. There is no mention of subjective expert agreement or a need for adjudication in these types of tests.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "8. Discussion of Clinical Tests Performed: Not Applicable". This device is a compressor; clinical studies involving human readers and interpretation are not relevant to its type of evaluation for 510(k) clearance.

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

This question is not applicable to the device described. This is a physical medical device (compressor), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used:

The "ground truth" for this device's evaluation is primarily established by:

• Engineering Standards and Guidelines: UL1431, FDA DCRND Reviewer Guidance (November 1993 for Premarket Notification Submissions and for Home Use Respiratory Devices), IEC 801-4, and IEC-801-5.
• Predicate Device Performance: The DeVilbiss Model 4650D Compressor Nebulizer (K#931015) serves as a benchmark for comparable performance characteristics (compressor operating pressure, liter flow ranges).

These standards and predicate device performance effectively serve as the "ground truth" to which the new device's performance is compared for demonstrating substantial equivalence.

8. The Sample Size for the Training Set:

This question is not applicable. The device is a hardware compressor, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

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

This question is not applicable for the same reason as point 8.

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