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Airistar Air Purification Systems (Model 1000) are intended for use in filtering airborne particles from air for medical purposes.

The Airistar Air Purification Systems - Model 1000 are medical air cleaners designed to help remove particulate matter from the air. These systems are for home use and use in hospitals, nursing homes, schools, offices, etc.

The Model 500 Airistar Air Purification System contains software and a display panel to program runs times and fan speeds, the panel also displays filter life indicator bar. The Model 1000 Airistar Air Purification System is operated via a power switch and control knobs to adjust the fan speed. Both models have 3 fan speeds and contain a 6 Stage filter system.

The provided text describes the Airistar Air Purification Systems (Model 500 & Model 1000) and its 510(k) submission. However, it does not contain information about specific acceptance criteria, a detailed study proving device performance against those criteria, or most of the requested metrics related to a clinical study. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than comprehensive performance study results.

Here's an analysis based on the provided text, highlighting the absence of information for many of your questions:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria (e.g., a certain percentage of particle removal at a specific size, or a CAD performance metric) are explicitly detailed in the document. The general statement is that "Bench testing has confirmed the devices' ability to remove particles efficiently."

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. No clinical test set involving patient data is described. The testing referred to is "bench testing."
• Data Provenance: Not applicable. The testing is described as "bench testing," implying laboratory-based testing, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No mention of expert ground truth establishment for a test set is present, as the testing was bench testing.

4. Adjudication method for the test set

Not applicable. No test set involving human data requiring adjudication is described.

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 purification system, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or mentioned.

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

Not applicable. This is not an AI algorithm; it's a physical air purification device. The "performance" is its physical ability to filter air, which would inherently be "standalone" in its function. The document mentions "bench testing" which is a standalone evaluation of the device's physical capabilities.

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

For the mentioned "bench testing," the ground truth would be established by objective measurements from laboratory equipment (e.g., particle counters) following established testing standards for air filtration efficiency. No human-derived ground truth (like expert consensus, pathology, or outcomes data) is relevant or mentioned.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device is not an AI/machine learning system.

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

Not applicable. No training set is involved.

Summary of what the document does provide regarding "proof" of meeting criteria:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance data against specific, quantitative acceptance criteria.

• Substantial Equivalence: The core argument is that the Airistar Air Purification Systems (Model 500 & Model 1000) have the same intended use and either identical technological characteristics or different ones that do not raise new safety or effectiveness concerns compared to the predicate devices (Hepa-Care Air Cleaner K984116, Mobile Particulate Contamination Control System K023693, Advanced Air Cleaner System K012549).
• Bench Testing: The document states that "Bench testing has confirmed the devices' ability to remove particles efficiently." This is a general statement without specific metrics or protocols detailed.
• Ozone Testing: "Underwriters Laboratory testing showed the UV lamp produced zero ozone." This is a specific performance metric, stating a zero-level finding.

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