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The Consolidated HC Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities using saturated steam as the sterilizing agent. They are equipped with factory programmed cycles. The factory programmed cycles, the chamber and overall dimensions, and the number of standard test items per AAMI ST8:2013 for all models of the HC Series steam sterilizers are provided below.

The steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam (reference 21 CFR Part 880.6880). Three models have been selected for the Consolidated HC Sterilizer product line: Model 3AV-HC, Model 26AV-HC, and Model 26BV-HC. The sterilizer will be targeted for sale into Ambulatory Surgery Centers (ASCs), Clinics, and Hospitals.

The Consolidated HC Steam Sterilizers are for general purpose gravity, vacuum, or liquid steam sterilization of heat and moisture-stabile medical goods, surgical instruments, and supplies. All models utilize both gravity/downward air displacement with positive-pressure pulse conditioning and pressure/vacuum pulsing for dynamic air removal. The programmed cycles are easily accessed and are password protected. All cycle phases are sequenced and monitored by a PLC-based control system, providing both audible and visual notification of deviation from critical operating parameters. These sterilizers can either be supplied for connection to direct building steam supply of 50-80 PSI of steam pressure or come equipped with an integral, electrically heated steam generator.

Here's a breakdown of the acceptance criteria and study information for the Consolidated HC Steam Sterilizer, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes non-clinical tests against various standards. It does not provide specific sample sizes for these tests in terms of the number of devices tested or the number of sterilization cycles performed for each criterion. The provenance of this data is internal testing conducted by Consolidated Machine Corp. (the manufacturer) to demonstrate compliance with recognized industry standards. The data is reported as part of a premarket notification to the FDA. It is prospective data generated specifically for regulatory submission.

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

This information is not provided in the document. For non-clinical tests based on engineering and performance standards (like AAMI, UL, IEC, ASME), the "ground truth" is typically established by fulfilling the defined criteria and measurement methodologies specified within those standards. This would involve calibrated equipment and trained technicians/engineers, rather than a panel of clinical experts.

4. Adjudication Method for the Test Set

This information is not applicable in the context of the provided non-clinical testing. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessment (e.g., image reading), not for objective performance tests against engineering standards.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing was used in support of this submission." This device is a medical sterilizer, and its effectiveness is determined by its ability to achieve a Sterility Assurance Level (SAL) through validated physical and biological parameters, not by human interpretation of results.

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

This question is not applicable as the device is a steam sterilizer, not an AI algorithm. Its performance is inherent to its mechanical and control systems.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is based on established industry standards and regulatory requirements. For example:

• Performance: AAMI ST8:2013 (R)2018 (a standard for steam sterilization in healthcare facilities). This standard outlines the microbiological and physical requirements for effective sterilization, often involving the use of biological indicators that demonstrate a defined kill rate.
• Safety (Electrical, EMC, Pressure Vessel, Generator): UL, IEC, and ASME standards, which define objective measurement criteria for electrical safety, electromagnetic compatibility, and structural integrity under pressure.
• Sterility Assurance Level (SAL): Defined as 10^-6, meaning there is a 1 in 1,000,000 probability of a viable microorganism being present on a sterilized item. This is a universally accepted microbiological standard for sterilization.

8. The Sample Size for the Training Set

This question is not applicable. This device is a physical sterilizer, not an AI/machine learning model that requires a training set.

9. 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.

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