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510(k) Data Aggregation
(42 days)
Aerus Medical Guardian,model F170A
The Aerus Medical Guardian, model F170A is a device intended for medical purposes that is used for the reduction of staphylococcus epidermidis and erwinia herbicola bacteria, MS2 and Phi-X174 viruses and aspergillus niger fungal spores and bacillus globigii bacterial spores from the air in a temperature-controlled professional healthcare environment of 7071°F, 4045% RH.
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The provided document describes the Aerus Medical Guardian, model F170A, a medical ultraviolet air purifier intended for the reduction of specific bacteria, viruses, and fungal/bacterial spores in professional healthcare environments.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the reported performance of the device in demonstrating the reduction of various microorganisms. The device must achieve a certain "Log-Reduction" for each organism. The table below outlines these:
| Organism Type | Organism Name | Acceptance Criteria (Log-Reduction) | Reported Device Performance (Avg Log-Reduction) |
|---|---|---|---|
| Bacteria | Staphylococcus epidermidis | Not explicitly stated but implied >= 5.95 | 5.95 |
| Bacteria | Erwinia herbicola | Not explicitly stated but implied >= 5.12 | 5.12 |
| Virus | MS2 | Not explicitly stated but implied >= 5.58 | 5.58 |
| Virus | Phi-X174 | Not explicitly stated but implied >= 4.19 | 4.19 |
| Fungal Spore | Aspergillus niger | Not explicitly stated but implied >= 4.12 | 4.12 |
| Bacterial Spore | Bacillus globigii | Not explicitly stated but implied >= 4.22 | 4.22 |
2. Sample sized used for the test set and the data provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). The table simply presents "Avg Log-Reduction," suggesting a summary of experimental results.
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. The "ground truth" in this context refers to the measured reduction of microorganisms in a controlled laboratory setting, not to expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the "ground truth" is a direct measurement, not an expert consensus process 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
This information is not applicable. The device is an air purifier, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device's performance is standalone in its function as an air purifier; there is no "human-in-the-loop" component in its direct operation for microorganism reduction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device's performance is based on direct laboratory measurements of microorganism reduction. This involves culturing and quantifying the specific bacteria, viruses, and spores before and after exposure to the device in a controlled environment. The "Log-Reduction" is a quantitative measure derived from these laboratory experiments.
8. The sample size for the training set
This information is not applicable. This is a physical device (air purifier), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the reason stated above.
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