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510(k) Data Aggregation
(557 days)
The Airdog is a mobile air cleaner intended to be used to remove particles from the air for medical purposes. The device is intended for indoor use only. The Airdog has been demonstrated to effectively inactivate H3N2 and reduce Staphylococcus albus by 4 log with L4 speed.
The Airdog X5 Recirculating Air Cleaner is a floor-standing air cleaner with an air quality sensor. The air from the room enters the X5 and passes a pre-filter, ionization frame, ionization field, collecting plates and carbon layer that captures particular matter and virus from the air. The X5 contains multiple PCB modules, air quality sensor, device status indicators, power switch and a display panel it allows user to select between different operation parameter, including auto-mode, sleep mode and wind speed. The Ionization Wireframe and the Collecting Plate can be cleaned routinely and are reusable. X5 is powered from an AC wall outlet. It is intended to be used indoors only.
This document is a 510(k) Pre-market Notification from the FDA regarding the Airdog X5 Recirculating Air Cleaner (model KJ300F-X5). It's a regulatory approval document and thus primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed scientific study report with all the requested specifics.
Based on the provided text, here's the information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria / Predicate Performance (K200321 Novaerus NV1050) | Reported Device Performance (Airdog X5) |
|---|---|---|
| Reduction of Biological Agents | Bacillus Globigii endospores and MS2 phage reduced by 3 log in 10 minutes and 4 log in 15 minutes. | H3N2 Influenza virus inactivating by 99.99% (4 log) with L4 speed. Staphylococcus albus reduced by 99.99% (4 log) in 1 hour. |
| Filtration of Particles | 4 log reduction in 0.5 to 2.0 μm sized particles in 10 minutes in a 580ft³ (16.4m³) sealed room. | Produces a 4 log reduction in PM2.5 particles in 120 minutes in a 30 m³ chamber. |
| Ozone Emitted | Below 10 ppb (Implies meeting regulatory requirements, which are typically <50 ppb for air purifiers). | Meet the requirements of UL867 (<50ppb) for ozone and USA CRB. (ETL test results also show that even if the carbon net is removed, the ozone is lower than regulatory requirements). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes (e.g., number of replicates for each test run) for the biological agent inactivation, particle reduction, or ozone emission tests.
The data provenance is not explicitly stated as "retrospective" or "prospective." However, these were undoubtedly prospective bench tests conducted to evaluate the device's performance against specific standards and claims. The country of origin for the tests is not specified, but the manufacturer is BeiAng Air Tech Ltd. located in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the studies described are bench tests evaluating the physical and biological performance of an air cleaner, not human-centric studies requiring expert interpretation of data like medical image analysis. The "ground truth" for these tests would be established by scientific measurement standards and protocols in a controlled laboratory environment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for bench tests. These tests are quantitative measurements, not subjective evaluations requiring adjudication.
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 an air cleaner and does not involve human readers or AI assistance in a diagnostic context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an air cleaner, not an algorithm. The performance described is its standalone mechanical and biological effectiveness.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the biological agent reduction and particle filtration, the "ground truth" is based on controlled laboratory measurements of the concentration of specific microorganisms or particles before and after air cleaner operation, relative to standard controls. For ozone emission, the "ground truth" is defined by regulatory standards (e.g., UL867) for maximum allowable ozone concentration.
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. (See #8)
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