(131 days)
The M-100 system is intended for use in filtering airborne particles from air for medical purposes.
The M-100 is a portable HEPA-Filtered clean hood for use in providing a controlled environment to class 100 (ISO class 3,5) for medical applications that require a high degree of airborne particulate control. The system is controlled by embedded firmware and runs on standard 120volt, 5 amp power. Pushbutton Controls include airflow, light intensity, lift/lower. Manual controls include Filter tilt/angle, brakes.
The provided text describes the Airex Inc. M-100 Mobile Medical Air Cleaner, a HEPA filtration system. However, it does not contain any information regarding acceptance criteria, device performance metrics, or any study details that would typically be associated with AI/ML medical devices.
The document is a 510(k) summary for a physical medical device (an air cleaner) from 2003, which precedes the widespread application of AI in medical devices and the associated regulatory requirements for studies proving AI performance.
Therefore, I cannot fulfill your request for the specific information points related to AI/ML device performance and study data (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment) because this information is not present in the provided text.
The closest relevant information provided is about the device's compliance with safety standards for physical medical equipment and air cleanliness:
- UL 2601 Standard for Medical Electrical Equipment Part 1: General Requirements for Safety
- ISO 14644-1 Classification of Air Cleanliness, Cleanrooms & Associated Controlled Environments, 1999.
These standards serve as "acceptance criteria" in a broad sense for the physical device's safety and air filtration capabilities, but they do not relate to the performance of an AI algorithm.
§ 880.5045 Medical recirculating air cleaner.
(a)
Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.(b)
Classification. Class II (performance standards).