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The STATIM 5000 Cassette Autoclave with Extended Cassette is a table-top steam sterilizer designed for the reprocessing of reusable instruments in a clinical setting. The extended cassette will accommodate unwrapped stainless steel instruments of a longer and more complex construction to a weight of up to 1.5 kg. With the addition of the extended cassette, the STATIM 5000 unit will now accommodate longer length rigid scopes of up to 49 cm or 19". The unit will process such instruments at a sterilization cycle of 132 ° C for 10 minutes.

STATIM 5000 Cassette Autoclave with Extended Cassette is a table-top steam sterilizer.

The provided text is a 510(k) clearance letter from the FDA for a device called "STATIM 5000 Cassette Autoclave with Extended Cassette". This document indicates that the device has been found substantially equivalent to a legally marketed predicate device.

The document does not contain any information regarding specific acceptance criteria, reported device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, I cannot answer your request based on the provided input. There is no study described in this document that proves the device meets specific acceptance criteria using the metrics you've listed. This type of FDA clearance relies on demonstrating equivalence to an existing device, rather than presenting a detailed performance study with quantifiable metrics as you've outlined.

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