(87 days)
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
| Acceptance Criteria Category | Specific Criteria/Test | Device Performance / Result |
|---|---|---|
| Environmental & Safety Testing (based on FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND) | ||
| Max Pressure & Flow vs. Temperature | Tested at +5°C, +20°C, and 40°C with 95% RH | Met requirements |
| Max Pressure & Flow vs. Line Voltage | Tested at 95V, 115V, and 132V | Met requirements |
| Storage | Tested at -20°C and +60°C | Met requirements |
| Fluid Spill Resistance | Tested | Met requirements |
| Surface and Air Temperatures | Tested | Met requirements |
| Sinusoidal Vibration | Tested | Met requirements |
| Impact (Drop) Resistance | Tested | Met requirements |
| Leakage Current & Dielectric Withstand (Electrical Safety) | Tested | Met requirements |
| EMC Testing | ||
| Radiated and Conducted Emission | Per CISPR 11 | Met requirements |
| Magnetic Field Emission | Per MIL-STD-462D, Method RE101 | Met requirements |
| Fast Surges | Per Reviewer Guidance document | Met requirements |
| Radiated and Conducted Immunity | Not applicable (no electronic components/microprocessors) | Not applicable |
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.
§ 868.6250 Portable air compressor.
(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.