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The Amsco Chimeron Small Steam Sterilizer models 16, 16CS, 16S, 20, 20C, 20CS, and 20S are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• . Prevacuum (Models 16, 16C and 20, 20C) - are equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
• Steam Flush Pressure-Pulse (SFPP) (Models 16CS, 16S and 20CS, 20S) are ● equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

The Amsco Chimeron Small Steam Sterilizer models 16, 16CS. 16S. 20, 20C. 20CS, and 20S are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum (Models 16, 16C and 20, 20C) are equipped with Prevacuum. . Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
• . Steam Flush Pressure-Pulse (SFPP) (Models 16CS, 16S and 20CS, 20CS) – are equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
  The chamber sizes of the proposed Amsco Chimeron Small Steam Sterilizer Models are as follows:
• · 16" x 16" x 26" (Models 16, 16C, 16CS, and 16S)
• · 20" x 20" x 38" (Models 20, 20C, 20CS, and 20S)

The provided text describes the Amsco Chimeron Small Steam Sterilizer and its validation but does not contain information about an AI/ML-enabled medical device. Therefore, it is not possible to extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI/ML device.

The document pertains to the effectiveness and safety validation of a conventional medical device – a steam sterilizer – according to established standards for sterilization equipment.

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