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The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles (Table 1):

The AMSCO 600 Steam Sterilizer uses saturated steam, generated from a house steam utility (e.g. boiler system) or from a steam generator, to sterilize heat-stable health care products.

The sterilizer accomplishes this by removing the air in the chamber, exposing the load to saturated steam for a defined combination of time and temperature, and drying the load. Removal of air from the chamber occurs using either of two methods, gravity displacement or mechanical vacuum. Once the air removal phase is completed, the sterilizer progresses to the steam exposure phase. During the steam exposure phase, every surface of the load is exposed to saturated steam for a defined combination of time and temperature. Once the steam exposure phase is completed, steam is removed from the chamber and the load is dried using the latent heat in the load and the vacuum pump.

The provided FDA 510(k) summary describes the AMSCO 600 Steam Sterilizer and its nonclinical testing. This document is a premarket notification for a medical device and thus the "acceptance criteria" here refers to the performance standards and regulatory requirements the device must meet to be deemed substantially equivalent to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes nonclinical testing and references compliance with standards like ANSI/AAMI ST8, IEC 61010-1, IEC 61010-2-40, FCC 47 CFR Part 15 - Subpart B, and ASME Boiler Pressure Vessel Code, Section VIII (Division 1).

• Sample Size: The document does not specify the sample size for these nonclinical tests in terms of specific units tested (e.g., number of sterilizers, number of loads processed). It states that "The testing demonstrated that subject device met the acceptance criteria described in these standards."
• Data Provenance: The document does not provide details on the country of origin of the data or whether the studies were retrospective or prospective. Nonclinical testing typically involves laboratory or in-house validation rather than patient data.

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

This information is not provided in the document. For nonclinical tests of a steam sterilizer, "ground truth" would typically be established by established engineering standards and methodologies, rather than expert human consensus on clinical images or outcomes.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to nonclinical engineering and performance testing of a steam sterilizer. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of results (e.g., by multiple radiologists).

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human interpretation is involved. The AMSCO 600 Steam Sterilizer is an automated sterilization device and does not involve human readers for interpretation in the context of its primary function.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This concept is not applicable to the AMSCO 600 Steam Sterilizer. It is a physical device that performs a function (sterilization) based on programmed cycles, not an algorithm that interprets data. Its performance is inherent in its operation and validated against physical and microbiological standards.

7. The Type of Ground Truth Used

The ground truth used for proving the device meets the acceptance criteria is based on:

• Engineering and Performance Standards: Compliance with recognized international and national standards (ANSI/AAMI ST8, IEC 61010-1, IEC 61010-2-40, FCC 47 CFR Part 15 - Subpart B, ASME Boiler Pressure Vessel Code, Section VIII (Division 1)). These standards define acceptable performance metrics for sterilization, electrical safety, EMC, and pressure vessel integrity.
• Microbiological Sterility Assurance: The specification of a Sterility Assurance Level (SAL) of 10^-6 implies that the ground truth for sterilization efficacy is the reduction of microbial population to a probability of 1 in a million, which is typically demonstrated through biological indicator challenges and physical parameter monitoring.

8. The Sample Size for the Training Set

This information is not applicable as the AMSCO 600 Steam Sterilizer is not an AI/ML device that requires a training set.

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

This information is not applicable as the AMSCO 600 Steam Sterilizer is not an AI/ML device that requires a training set and associated ground truth.

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