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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-600 and HC-1500 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-800 and HC-1000 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 371/2' x 54" (Model HC 1200)
  The Automated Load/Unload System (ALUS) automatically feeds loading cars packed with goods into and/or out of the sterilizer chamber, reducing the amount of handling by central supply workers. This includes ALUS tables for use with AMSCO Evolution medium steam sterilizers having automated chamber doors and the following chamber dimensions (width and height):
• · 26 x 26" (660 x 660 mm)
• 26 x 37½" (660 x 953 mm)

The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 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 26" x 39" (Model HC 600)
• · 26'' x 37 ½' x 66" (Model HC 1500)
  The Automated Load/Unload System (ALUS) automatically feeds loading cars packed with goods into and/or out of the sterilizer chamber, reducing the amount of handling by central supply workers. This includes ALUS tables for use with AMSCO Evolution medium steam sterilizers having automated chamber doors and the following chamber dimensions (width and height):
• · 26 x 26" (660 x 660 mm)
• · 26 x 37-1/2" (660 x 953 mm)

The Amsco Evolution Medium Steam Sterilizer models HC-800 and HC-1000 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:
• 0 26" x 26" x 49" (Model HC - 800)
• 26" x 26" x 61" (Model HC 1000) 0
  The Automated Load/Unload System (ALUS) automatically feeds loading cars packed with goods into and/or out of the sterilizer chamber, reducing the amount of handling by central supply workers. This includes ALUS tables for use with AMSCO Evolution medium steam sterilizers having automated chamber doors and the following chamber dimensions (width and height):
• · 26 x 26" (660 x 660 mm)
• · 26 x 37-1/2" (660 x 953 mm)

This document describes the premarket notification (510(k)) for the STERIS Amsco Evolution Medium Steam Sterilizer with Evolution Automated Loading and Unloading System (ALUS) in various models (HC-900 & HC-1200; HC-600 & HC-1500; HC-800 & HC-1000). The submission focuses on the addition of the ALUS hardware to existing sterilizer models.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of typical AI/software testing with data samples. Instead, the testing appears to be hardware-focused verification of the ALUS system with the sterilizers. The data provenance is not explicitly stated as retrospective or prospective clinical data, but rather as results from functional and electrical safety testing. Given the nature of the device (steam sterilizer and its automated loading system), this would typically involve testing performed by the manufacturer (STERIS Corporation) at their facilities or certified testing laboratories.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. The "ground truth" for this device's performance is objective compliance with engineering and safety standards (e.g., automatic loading/unloading functionality, ETL certification requirements) rather than expert interpretation of medical data.

4. Adjudication Method for the Test Set

Not applicable. The testing described is compliance-based functional and safety testing, not a study requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data, and the effect of AI assistance on their performance is measured. The device in question is a steam sterilizer with an automated loading system, which does not involve human interpretation of medical cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm-only performance study was not explicitly done in the context of typical AI algorithm evaluation. The "device" here includes hardware (sterilizer, ALUS) and software components for automation. The functional testing of the ALUS system demonstrates its standalone operation in terms of loading, unloading, and cycle initiation. However, this is not an "AI algorithm" in the conventional sense requiring standalone performance metrics like sensitivity/specificity on a dataset.

7. The Type of Ground Truth Used

The ground truth used for this device is based on engineering specifications and regulatory/safety standards.

• For functional testing: The ground truth is the successful execution of the specified actions (automatic loading, unloading, and proper cycle initiation) according to the device's design and operational requirements.
• For UL 73: 2011 Ed.10 (2018) evaluation: The ground truth is compliance with the electrical safety and performance requirements outlined in that specific UL standard, leading to ETL certification.

8. The Sample Size for the Training Set

Not applicable. The document describes a medical device (steam sterilizer with automated loading) whose functionality is based on electromechanical design and software programming, not on machine learning algorithms trained on a dataset. Therefore, there is no "training set" in the context of AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI algorithm. The device's operational parameters and safety features are established through engineering design, development, and adherence to relevant industry standards and regulations.

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