(148 days)
The Abracair Air Cleaner is intended for the reduction of aerosolized mold and bacteria within hospitals, nursing homes, medical facilities. The device may be used in occupied spaces within hospital environments such as baby an/or neonatal nurseries, hospital rooms, operating rooms, mortuaries, embalming rooms.
ABRACAIR Air Cleaner, QTZ300-60 and QTZ100-24 are devices that use a 6inch xenon flash lamp, doped with titanium within a reflecting chamber to irradiate air as the air passes through a baffled chamber. An internal fan draws air through a input filter at approximately 300 cubic feet per minute (CFM) or 100 CFM determined by model number.
The provided text describes an air cleaner device (ABRACAIR Air Cleaner, QTZ300-60 and QTZ100-24) and its premarket notification (510(k) K052732). However, it does not contain details about specific acceptance criteria or an explicit study proving the device meets quantitative performance metrics in a manner that allows for a table of reported device performance or many of the requested study details.
The document indicates that "No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug and Cosmetic Act." Instead, it mentions a test conducted by the Research Triangle Institute.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit quantitative acceptance criteria are stated in the document. The device's performance is described qualitatively.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Reduction of Airborne Contaminants | (Not defined quantitatively in document) | "ABRACAIR reduces aerosolized bacteria and fungi." |
| Safety Standards | (Not defined explicitly beyond general conformity) | "Tested to Underwriter Label safety standards and is eligible to bear the Canadian Standards Association (CSA) Mark with the C-US Indicator." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to a single test by the Research Triangle Institute without detailing the experimental setup, number of tests, or samples used.
- Data Provenance: The test was conducted by the "Research Triangle Institute." The country of origin of this specific test data is not explicitly stated but can be inferred to be the USA given the context of the 510(k) submission to the FDA. The study appears to be a prospective test designed to evaluate the device's efficacy.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document describes a technical performance test rather than a diagnostic or interpretive study requiring expert ground truth establishment for a test set. Therefore, this information is not applicable or provided. The "ground truth" would be the actual concentration of bacteria and fungi as measured by scientific instruments.
4. Adjudication Method for the Test Set
- Not applicable as this was a technical performance test, not one requiring human interpretation and adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not done. This device is an air cleaner, not an imaging or diagnostic device that typically requires human reader interpretation. The study focused on the device's ability to reduce airborne contaminants, not on human interpretation or diagnosis.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Yes, this was a standalone performance test of the device. The study assessed the efficacy of the ABRACAIR Air Cleaner itself in reducing airborne bacteria and fungi, without any human-in-the-loop component related to its primary intended function.
7. The Type of Ground Truth Used
- The ground truth for the "reduces aerosolized bacteria and fungi" claim would be direct measurement of the concentration of airborne bacteria and fungi (e.g., colony-forming units per unit volume of air) before and after air treatment by the device. This is a scientific measurement, not an expert consensus, pathology, or outcomes data in the medical diagnostic sense.
8. The Sample Size for the Training Set
- Not applicable. This device is an air cleaner, not a machine learning model that typically requires a training set. The "study" described is a direct performance test of the physical device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device and study.
In summary: The provided 510(k) summary focuses on general device description, intended use, and substantial equivalence to predicate devices, rather than detailed performance study results with quantitative acceptance criteria. The performance claim is qualitative ("reduces aerosolized bacteria and fungi") and is supported by a test from Research Triangle Institute, but the specifics of that test (methodology, raw data, statistical analysis, specific metrics, sample sizes, etc.) are not included in this document.
§ 880.6500 Medical ultraviolet air purifier.
(a)
Identification. A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.(b)
Classification. Class II (performance standards).