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510(k) Data Aggregation
(274 days)
PLASMAIR, MODEL T2006
The Plasmair Model T2006 is intended as a room air purifier/recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical cleaner. The System's dood for member of to supplement existing building air treatment and/or provide air treatment where none exists.
The device uses spatially modulated, amplified multidirectional electrostatic field technology to create cold plasmas for decontamination and capture of airborne particulates.
The provided text describes a 510(k) submission for a medical recirculating air cleaner (Plasmair™ Model T2006). Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical safety performance | Meets performance specifications |
| General performance | Meets performance specifications |
| Substantial equivalence to predicate device (Biological Controls, Inc, MICROCON 800MUV K972064) | Claimed to be substantially equivalent based on technological characteristics (spatially modulated, amplified multidirectional electrostatic field technology creating cold plasmas for decontamination and capture of airborne particulates) and performance data. |
| Intended Use as a room air purifier/recirculating air cleaner for filtering out and inactivating airborne particles. | Stated as the intended use, and the device is intended to supplement existing building air treatment and/or provide air treatment where none exists. |
2. Sample size used for the test set and the data provenance
The document states: "Electrical safety and performance data included in the submission established that the device meets the performance specifications." However, it does not specify the sample size used for the test set or the provenance of this data (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information regarding the number of experts used to establish ground truth or their qualifications. The evaluation appears to be based on engineering performance specifications rather than expert interpretation of medical images or conditions.
4. Adjudication method for the test set
The document does not specify an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not performed, nor is it applicable to this device. This device is an air filtration system, not an AI-powered diagnostic tool that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is not an algorithm, but a physical air filtration system. The "standalone" performance would refer to its effectiveness in filtering air, which is addressed by the "performance data" mentioned in the submission summary.
7. The type of ground truth used
The "ground truth" for this device appears to be defined by engineering performance specifications related to electrical safety and its ability to filter/decontaminate air. There is no mention of expert consensus, pathology, or outcomes data in the context of establishing ground truth for the device's primary function.
8. The sample size for the training set
The concept of a "training set" is not applicable to this device. It is not an AI/machine learning model that undergoes training.
9. How the ground truth for the training set was established
As the concept of a training set is not applicable, this question is also not relevant.
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