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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.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in terms of clinical or image-based samples. The performance metrics relate to controlled laboratory tests (e.g., "30m³ chamber" for particle filtration, specific test conditions for virus/bacteria inactivation).
• Data Provenance: The tests appear to be laboratory-based ("Bench tests"). No human subject data or image data is mentioned.

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)

• Not applicable. Ground truth for an air purifier's performance (e.g., particle reduction, virus inactivation) is established through standardized laboratory testing protocols, not expert clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This is not a study involving human readers or subjective interpretations 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 purifier, not an AI diagnostic or assistance tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Performance data provided is "standalone" in the sense that it's the device's measured performance in controlled laboratory settings. There is no algorithm or AI component mentioned in the description that would operate independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for the performance claims (e.g., 99.99% reduction of H3N2) is based on laboratory standard testing methodologies for air purification devices, measuring actual physical and biological reductions in controlled environments.

8. The sample size for the training set

• Not applicable. This device is an air purifier, not an AI/ML system that requires a "training set."

9. How the ground truth for the training set was established

• Not applicable. No training set is involved for this type of device.

In summary: The provided document is a 510(k) summary for an air purifier, not a report on an AI/ML diagnostic or assistive device. Therefore, most of the requested information regarding AI performance metrics, expert reviews, and study design for AI models is not present and not relevant to this specific device's clearance. The "performance data" focuses on its physical and biological purification capabilities as demonstrated through laboratory bench tests.

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