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The Amsco Evolution Medium Steam Sterilizer Models HC-900 and HC-1200 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. .
• Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-• Dick) cycles.

The Amsco Evolution Medium Steam Sterilizer models HC-900 and HC-1200 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and ● DART (Bowie-Dick) cycles.
• Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, . Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
  The chamber sizes of the proposed Amsco Evolution Medium Steam Sterilizer Models are as follows:
• · 26'' x 371/2' x 42" (Model HC 900)
• 26'' x 37½' x 54'' (Model HC 1200)

The provided text describes a 510(k) premarket notification for a steam sterilizer device, not an AI/ML-based medical device. Therefore, much of the requested information regarding AI/ML device testing (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable or present in this document.

However, I can extract the acceptance criteria and performance data for this traditional medical device:

Acceptance Criteria and Device Performance for Amsco® Evolution Medium Steam Sterilizer

The STERIS Corporation performed verification activities to ensure that modifications to their Amsco® Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200) did not affect its safety or effectiveness. The study demonstrates that the device passed all established acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Note: "Per ST8" refers to AAMI ST8, a recognized standard for hospital steam sterilizers. "Per IEC 61010-1" refers to an international standard for electrical equipment for measurement, control, and laboratory use, which includes safety requirements.

Information Not Applicable or Available in the Provided Document (Pertaining to AI/ML Devices)

This document describes a traditional medical device (steam sterilizer), not an AI/ML device. Therefore, the following information, typically required for AI/ML device studies, is not applicable or found in this submission:

2. Sample sizes used for the test set and the data provenance: Not applicable. Performance testing for sterilizers involves functional checks and adherence to standards rather than data sets like those used for AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a sterilizer's performance is objective (e.g., passing a specific test cycle, electrical safety standards met), not based on expert consensus of complex data.
4. Adjudication method for the test set: Not applicable. Performance is binary (pass/fail) against objective criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an imaging or diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device's performance is inherently "standalone" in its function as a sterilizer.
7. The type of ground truth used: For this device, ground truth is based on established engineering and safety standards (ST8, IEC 61010-1), and functional performance checks (e.g., proper actuation, no alarms, proper door function after multiple cycles). It is not expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device trained on data.
9. How the ground truth for the training set was established: Not applicable.

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