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The AMSCO Chimeron Medium Steam Sterilizers (Models 36H, 48H, 36SL, 48SL, 60SL, 36CH, 48CH, 60CH, 36CSL, 48CSL and 60CSL) are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configuration:

. Prevacuum - equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

Device Description

The AMSCO Chimeron Medium Steam Sterilizers (Models 36H, 48H, 60H, 36SL, 48SL, 60SL, 36CH, 48CH, 60CH, 36CSL, 48CSL and 60CSL) are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configuration:

Prevacuum equipped with Prevacuum, Gravity, Liquid, Leak Test and DART . (Bowie-Dick) cycles.
The chamber sizes of the proposed AMSCO Chimeron Medium Steam Sterilizer Models are as follows:
26" x 37.5" x 36" (Models 36H, 36CH, 36SL, 36CSL) .
· 26" x 37.5" x 48" (Models 48H, 48CH, 48SL, 48CSL)
26" x 37.5" x 60" (Models 60H, 48CH, 48CH, 48CSL) .

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the AMSCO Chimeron Medium Steam Sterilizer, based on the provided text:

Acceptance Criteria and Device Performance

The STERIS AMSCO Chimeron Medium Steam Sterilizer's acceptance criteria are defined by its ability to achieve a sufficient Sterility Assurance Level (SAL) and meet specific performance benchmarks for various sterilization cycles, as outlined in ANSI/AAMI ST8: 2008.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance and Study Findings (from verification studies)
Sterility Assurance Level (SAL)	Achieve an SAL of at least 10⁻⁶ probability of survival (complete kill of biological indicators)	All cycles (Gravity, Prevac, Liquid) demonstrated a sterility assurance level of at least 10⁻⁶ through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12.
Empty Chamber Thermal Conditions	Capable of providing steady-state thermal conditions consistent with the predicted SAL in the load (as per ANSI/AAMI-ST8 Section 5.4.2.5).	Empty chamber testing demonstrated that the sterilizer is capable of providing steady-state thermal conditions within the chamber that are consistent with the predicted SAL in the load; meets ANSI/AAMI-ST8 Section 4.4.2.
Fabric Test Pack (Gravity & Prevac cycles)	Moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots (as per ANSI/AAMI-ST8 Section 5.5.2.1 and 5.5.2).	All GRAVITY and PREVAC cycles using fabric test packs met the criteria: moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots.
Full Load Instrument Trays (Gravity & Prevac cycles)	Moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper (as per ANSI/AAMI-ST8 Section 5.5.4.1 and 5.5.4).	All GRAVITY and PREVAC cycles using full load instrument trays met the criteria: moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
Liquid Cycles	Water loss not exceeding 50 ml, and automatic sealing of the flask closure (as per ANSI/AAMI-ST8 Section 5.5.3.1 and 5.5.3).	All LIQUID cycles met the criteria: water loss not exceeding 50 ml, and automatic sealing of the flask closure.
DART Cycle (Bowie-Dick Test Pack)	Demonstrate a uniform color change throughout the test sheet (as per ANSI/AAMI-ST8 Section 5.6.1.1 and 5.6.1).	The DART cycle demonstrated a uniform color change throughout the test sheet.
Software Validation	Meet FDA's moderate level of concern recommendations for software in medical devices.	Software validation for cycle operation was performed according to FDA's "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (05/11/05)."
Safety Compliance	Compliance with national safety codes and standards.	Complies with ANSI/UL 61010-1, CAN/CSA C22.2 No. 61010-1, UL 61010A-2-041, CAN/CSA C22.2 No 1010.2.041, and ASME Boiler Pressure Vessel Code, Section VIII (Division 1).

Study Information

Sample sizes used for the test set and the data provenance:
- The document describes "verification studies" for various cycles and load types, but does not provide specific numerical sample sizes (e.g., number of test packs, instrument trays, or flasks tested).
- The studies were part of STERIS Corporation's internal validation process, referencing compliance with ANSI/AAMI ST8: 2008. The data provenance is internal to STERIS and is associated with the device's manufacturing and testing. The studies appear to be prospective validation studies performed for regulatory submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document refers to validation against standards like ANSI/AAMI ST8: 2008, which are developed by independent organizations. The "ground truth" for sterilization effectiveness (e.g., SAL, F₀ value, moisture retention, color change) is established by the methods, parameters, and success criteria defined within these industry standards.
- There is no mention of individual expert adjudicators for the test set. The ground truth is determined objectively by meeting the quantifiable criteria of the referenced standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method involving human experts (like 2+1 or 3+1 consensus) is described, as the evaluation is based on objective, measurable parameters against established engineering and sterilization standards.
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:
- No MRMC or AI-assisted study was performed or is relevant to this device. This is a steam sterilizer, not an AI-powered diagnostic or assistive technology.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "effectiveness" section describes the standalone performance of the sterilizer itself (algorithm only, if considering the control system as an algorithm) in achieving sterilization parameters without human intervention during the cycle. The sterilizer's control system operates autonomously once programmed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is based on established industry standards and scientific principles of sterilization, specifically defined by ANSI/AAMI ST8: 2008. This includes objective measurements such as:
  - Complete kill of biological indicators.
  - Achieving a specific Fo (lethality) value.
  - Quantifiable moisture retention levels.
  - Observable physical changes (e.g., uniform color change of a Bowie-Dick test sheet).
  - Measurements of water loss and flask sealing for liquid cycles.
The sample size for the training set:
- This information is not applicable. The AMSCO Chimeron Medium Steam Sterilizer is a mechanical and electrical device with a control system; it is not an AI/machine learning device that requires a "training set" in the conventional sense. Its "training" involves engineering design, calibration, and adherence to established physical and chemical principles of steam sterilization.
How the ground truth for the training set was established:
- This question is not applicable, as there is no "training set" for this type of device. The ground truth for its design and operational parameters is rooted in decades of scientific understanding of sterilization, established engineering principles, and validated industry standards like ANSI/AAMI ST8.

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