COMPRESSOR/NEBULIZER #3650 by DEVILBISS HEALTH CARE, INC.

The DeVilbiss Model 3650 Compressor / Nebulizer is designed for use on the order of a physician for the treatment of respiratory diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease. In terms of function, safety and effectiveness this device is substantially equivalent to other legally marketed compressor / nebulizers commonly used for the treatment of respiratory diseases. The compressor is constructed of materials, both metal and plastic, that are similar or identical to legally marketed devices. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device (Underwriter's Laboratory Standard UL1431, Attachment D).

Used in conjunction with a jet (pneumatic) nebulizer, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The DeVilbiss Model 3650 compressor / nebulizer system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter (per the requirements of the BSI standard, Attachment E). This aerosol particle size performance is comparable to other legally marketed devices as noted in the Table of Comparison and the Discussion of Similarities and Performance Data (Sections 6.0 & 7.0).

AI/ML Overview

Given the provided text, it is not possible to provide a detailed response to the requested information regarding acceptance criteria and a study proving device conformance. The document is a 510(k) summary from 1997 for the DeVilbiss Model 3650 Compressor/Nebulizer, which pre-dates many of the modern requirements and practices for AI/ML device evaluations implicit in your questions.

Here's why and what can be extracted:

The document explicitly states: "The DeVilbiss Model 3650 Compressor / Nebulizer is substantially equivalent to other legally marketed compressor / nebulizers commonly used for the treatment of respiratory diseases." This indicates a predicate device comparison rather than a standalone clinical study with the kind of modern metrics you're requesting.

Here's what can be gathered, and what cannot:

A table of acceptance criteria and the reported device performance

Acceptance Criteria Mentioned (Implicit/Explicit):
- "majority of the aerosol by mass contained in particles less than 5 microns in diameter (per the requirements of the BSI standard, Attachment E)."
- Compliance with electrical and mechanical safety standards (Underwriter's Laboratory Standard UL1431, Attachment D).
- Functional and safety equivalence to legally marketed predicate devices.
Reported Device Performance:
- "This aerosol particle size performance is comparable to other legally marketed devices." No specific numerical value for "majority" is given within this summary, only that it meets the BSI standard requirement.
- Functionally, converts liquid medication into aerosol.
- Electrically and mechanically safe per UL1431.

Acceptance Criteria	Reported Device Performance
Majority of aerosol by mass < 5 microns diameter (per BSI standard)	Performance comparable to other legally marketed devices (meets BSI)
Compliance with electrical/mechanical safety standards (UL1431)	Unit designed and manufactured to comply with UL1431
Substantially equivalent in function, safety, and effectiveness to predicate devices	Deemed substantially equivalent

Sample size used for the test set and the data provenance
- Not provided. The document describes a comparison and compliance with standards rather than a clinical trial with a "test set" in the AI/ML sense.
- Data Provenance: Not specified, but likely laboratory testing given the nature of the device (compressor/nebulizer).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. This is relevant for studies involving human interpretation (e.g., imaging devices, AI diagnostics), not for a compressor/nebulizer's physical performance characteristics.
Adjudication method
- Not applicable/Not provided.
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 physical medical device (compressor/nebulizer), not an AI/ML diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm.
The type of ground truth used
- Not explicitly stated in terms of "ground truth" as per AI/ML. However, the "truth" for this device's performance would be established through:
  - Physical measurement: e.g., aerosol particle size distribution determined by laboratory methods.
  - Standard compliance: Verification against UL1431 and BSI standards.
  - Comparison to predicate devices: Performance data of legally marketed devices served as the benchmark for "substantial equivalence."
The sample size for the training set
- Not applicable. This device is not an AI/ML model that requires a "training set."
How the ground truth for the training set was established
- Not applicable.

Summary

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K970289

APR 1 5 1997

3.0 Summary of Safety and Effectiveness

The Table of Comparison and the Performance Evaluations (Sections 6.0 & 7.0) show that in terms of safety and effectiveness, the new DeVilbiss Model 3650 Compressor / Nebulizer is substantially equivalent to legally marketed predicate devices.

Legally Marketed Predicate Devices DeVilbiss Model 5650

Healthdyne, Inc. 323

510(k) Registration # K 923888 K 922623

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).