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510(k) Data Aggregation
(86 days)
Aerobiotix, Inc.
The Aerobiotix AEROCURE-MD air purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation. In addition, the device removes particles from the air via HEPA filtration.
The AEROCURE-MD is a free-standing flow-through air purification device which uses germicidal ultraviolet light with supplemental HEPA filtration to remove airborne contamination. The AEROCURE-MD device has a wheeled metal housing with electrical controls and outer dimensions of 74 x 62 x 178 cm which is placed within a room. The device has a pleated pre-filter, ultraviolet photolytic chamber equipped with germicidal ultraviolet lamps, and a 99.97% HEPA filter. The AEROCURE-MD is for over-the-counter use.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "AEROCURE-MD Medical Air Purifier." This document outlines the device's characteristics, its comparison to a predicate device, and the results of non-clinical testing.
Based on the provided information, here's a breakdown of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
| Name of Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Microorganism Reduction Testing | Demonstrate reduction of representative organisms in single-pass testing | Greater than 99.9% reduction in single-pass testing | Demonstrated effectiveness against MS2 virus, B. atropheus, S. epidermidis. |
| UL 507: 2017 Ed. 10 | Electrical safety and mechanical integrity | PASS | PASS |
| IEC 60601-1-2 Ed. 4.0 | Electromagnetic compatibility (EMC) for medical electrical equipment | PASS | PASS |
| Particulate Reduction Testing | Demonstrate ability to remove airborne particles | SIMILAR TO PREDICATE | SIMILAR TO PREDICATE |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for each test (e.g., number of runs, amount of airflow, duration of test). It only states that the testing was "single-pass testing" for microorganism reduction.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that it is a 510(k) submission to the FDA, it is expected that the testing was conducted in a controlled, accredited environment to demonstrate the device's performance for regulatory clearance. It would be considered prospective testing as it was specifically done to support this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The "ground truth" for the performance of an air purifier is established through objective, controlled laboratory measurements of its ability to filter particles and inactivate microorganisms, not through expert consensus or interpretation of images. The tests listed (Microorganism Reduction, UL, IEC, Particulate Reduction) are engineering and microbiology performance tests.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation of medical data (e.g., radiology reads) where there might be disagreement among experts. For performance testing of a physical device like an air purifier, the results are quantitative measurements, not subject to adjudication in the same way. The results are either PASS/FAIL or a measured reduction percentage.
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 information is not applicable. This device is an air purifier, not an AI-assisted diagnostic tool or system that involves human readers. Therefore, an MRMC comparative effectiveness study involving human readers is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical air purifier. Its performance is measured directly, not through an algorithm or AI.
7. The type of ground truth used
The ground truth for this device's performance is based on objective, quantitative laboratory measurements of:
- Microorganism reduction: Measured effectiveness against specific viral and bacterial surrogates (MS2 virus, B. atropheus, S. epidermidis) in a controlled environment.
- Electrical safety and performance: Compliance with established engineering standards (UL 507, IEC 60601-1-2).
- Particulate reduction: Measured ability to remove airborne particles, demonstrated to be similar to the predicate device.
8. The sample size for the training set
This information is not applicable. This is a physical device, not a machine learning or AI algorithm that requires a training set. The device's operation is based on established principles of UV radiation and HEPA filtration, not on learned patterns from a dataset.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for a physical air purifier.
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