(34 days)
The ParaPost System Sterilizable Organizer (The Organizer) is used for the ultrasonic cleaning and subsequent steam sterilizing (autoclaving) of contaminated dental/medical instruments and devices (accessory devices, endodontic files and reamers, drills and burs as well as endodontic posts). in a 132°C gravity cycle for 12 minutes.
The ParaPost System Sterilizable Organizer (The Organizer) is used for the ultrasonic cleaning and subsequent steam sterilizing (autoclaving) of contaminated dental/medical instruments and devices (accessory devices, endodontic files and reamers, drills and burs as well as endodontic posts).
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (ParaPost System Sterilizable Organizer). It does not contain information about acceptance criteria, device performance, study details, sample sizes, or ground truth establishment. This document is a regulatory approval, not a scientific study report.
Therefore, I cannot extract the requested information to fill the table and answer the questions.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).