(92 days)
The Airdog X8 Air Purifier is a mobile air cleaner intended to remove particles from the air for medical purposes. The device is intended for indoor use only. The Airdog X8 has been demonstrated to effectively inactivate H3N2 and reduce Staphylococcus albus by 4 log with L5 speed.
The Airdog X8 Air Purifier (X8) is a mobile air cleaner. The air from the room enters the X8 and passes a pre-filter, ionization frame, ionization field, collecting plates and carbon filter that captures particular matter and biological agents from the air. The X8 contains multiple PCB modules, device status indicators, power switch and a display panel, it allows user to select between different operation parameters, including auto-mode, sleep mode and wind speed. The Ionization wireframe and the collecting plate can be cleaned routinely and are reusable. X8 is powered from an AC wall outlet. It is intended to be used indoors only. The device is not intended to be connected to other instruments or medical devices.
The provided text is a 510(k) Summary for the Airdog X8 Air Purifier. It lacks the details typically found in a study proving a device meets specific acceptance criteria, especially for an AI/ML-driven device with complex performance metrics like those involving human readers or expert consensus. This document pertains to an air purifier, and its "performance data" is focused on physical and biological filtration capabilities, not on an AI's diagnostic or assistive accuracy.
Therefore, I cannot extract information related to:
- Sample size used for the test set and data provenance (e.g., country of origin, retrospective/prospective)
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size
- Standalone (algorithm only) performance
- Type of ground truth used (expert consensus, pathology, outcomes data)
- Sample size for the training set
- How ground truth for the training set was established
However, based on the provided text, I can infer the "acceptance criteria" and "reported device performance" related to the air purifier's function.
Here's a breakdown of what can be extracted:
1. A table of acceptance criteria and the reported device performance
While not explicitly called "acceptance criteria" with pass/fail thresholds in the typical AI/ML sense, the document lists specifications and test results that serve as performance benchmarks.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biological Agent Reduction (H3N2 Influenza virus) | 99.99% reduction with L5 speed operation (Airdog X8) |
| Biological Agent Reduction (Staphylococcus albus) | 4 log reduction with L5 speed (Airdog X8) |
| Particle Filtration (PM2.5) | 4-log reduction in PM2.5 particles in 120 minutes in a 30m³ chamber (Airdog X8) |
| Ozone Emission | Meets the requirements of UL867 ( |
§ 880.5045 Medical recirculating air cleaner.
(a)
Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.(b)
Classification. Class II (performance standards).