Search Results

The Airsonett Airshower Air 3 is a Mobile Air Cleaner intended to be used to remove particles from the air for medical purposes. The device is intended for home use only.

The Airsonett Airshower Air 3 Mobile Medical Air Cleaner is an adjustable, portable, personal system for use in providing a controlled environment for medical applications that require a high degree of airborne particulate control. The system is controlled by embedded firmware and runs on standard 115 volt, 1.7 ampere power. Pushbutton controls include airflow and cooling capacity. Manual controls include till/angle of air outflow.

The Airsonett Airshower Air 3 Mobile Medical Air Cleaner device provides a method, using air cooling, for guiding the treated ambient air so as to obtain an air flow distribution directly to the users breathing zone, thereby forming a treated air zone surrounding the user.

This document describes the Airsonett Airshower Air 3 Mobile Medical Air Cleaner, a device intended to remove particles from the air for medical purposes in a home setting. The document focuses on demonstrating its substantial equivalence to a predicate device, the BREATHE EASY (Models AD and CD) by RespirAid Ltd (K981841).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Airsonett Airshower Air 3 are implicitly defined by its comparison to the predicate device, BREATHE EASY. The goal is to show comparable or improved performance for key metrics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the traditional sense of a clinical study involving human subjects or a large dataset of patient information. This is a medical device clearance based on substantial equivalence to an existing predicate device. The "test set" in this context refers to the device itself being tested in a laboratory setting to verify its specifications.

• Sample Size: The document implies testing was performed on one or more units of the Airsonett Airshower Air 3 to verify its functional and safety specifications. It does not provide a specific number of devices tested.
• Data Provenance: The document does not explicitly state the country of origin for the testing data. However, Airsonett Inc. is located in Fort Mill, SC, and the submission date is April 9, 2008, suggesting the testing was likely conducted in the United States or a country with recognized testing standards. The testing appears to be prospective in the sense that physical tests were conducted on the manufactured device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of external experts establishing a "ground truth" for the performance metrics in this 510(k) submission regarding the device's technical specifications. The performance claims (e.g., airflow, sound level, air quality) are derived from engineering tests and measurements conducted on the device itself by the manufacturer or a certified testing laboratory. These are objective measures, not subjective interpretations requiring expert consensus as might be the case for diagnostic imaging.

4. Adjudication Method for the Test Set

Not applicable. Since the "test set" consists of objective engineering measurements against predefined specifications (or comparison to a predicate device's specifications), there is no human adjudication process involved for establishing ground truth or performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document does not mention any MRMC comparative effectiveness study. The device is a medical air cleaner, not a diagnostic imaging device that typically uses MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done

This concept is not applicable to the Airsonett Airshower Air 3. This device is a physical air cleaner, not an algorithm or AI system. Its performance is inherent to its mechanical and electrical design, not an "algorithm only" mode.

7. The Type of Ground Truth Used

The "ground truth" for the acceptance criteria and performance claims are objective engineering measurements and compliance with established standards.

• Air Quality: Verified by measuring particle counts (Class 100-1000 according to FED STD 209E) in the treated air envelope.
• Sound Level: Measured in dB(A).
• Air Flow: Measured in m³/h.
• Safety and EMC: Verified by testing against IEC 60601-1 and other relevant standards.

There is no "expert consensus," "pathology," or "outcomes data" used as ground truth for these technical specifications.

8. The Sample Size for the Training Set

Not applicable. As a physical medical device (air cleaner), there is no 'training set' in the context of machine learning or AI. The design and manufacturing processes are refined through engineering, prototyping, and testing, not by training an algorithm on a dataset.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device