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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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Consolidated SSR and SR MC-Series Steam Sterilizers are intended for use by health care facilities. They are to be used to sterilize wrapped and unwrapped surgical instruments, linens, and liquids (liquids not intended for direct patient contact) by means of pressurized steam.

The Consolidated SR and SSR Series Sterilizers are for general purpose gravity or vacuum steam sterilization of heat and moisture-stabile goods, surgical instruments, and supplies. All models utilize both gravity/downward air displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 16 cycles can be easily accessed and are password protected. All cycle phases are sequenced and monitored by the Mark V control system, providing both audible and visual notification of deviation from certain operating parameters. These sterilizers can either be supplied for connection to direct building steam supply of 50-80 PSI of pressure or come equipped with an integral, electrically heated steam generator.

The provided text describes a 510(k) summary for the Consolidated SSR and SR MC-Series Steam Sterilizers, Models: SSR-2A, SSR-3A, and SR-24E.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in terms of performance metrics like sterilization rates or specific temperature/pressure ranges that must be met. Instead, it asserts that the device's functionality and conformance were determined through testing. The "reported device performance" is implicitly that it did meet these unstated requirements.

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

The document states: "Biological and physical testing was conducted to determine device functionality and conformance to design input requirements."

• Sample Size for the Test Set: Not specified. The document does not provide details on the number of sterilization cycles, biological indicators, or physical measurements performed.
• Data Provenance: Not explicitly stated, but given that Consolidated Machine Corp. is a Boston, MA-based company and the FDA review process is for marketing in the US, the testing would presumably be conducted in the US. The document does not indicate if the data was retrospective or prospective, but performance testing for a new device would typically be prospective.

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

Not applicable. This device is an autoclave (steam sterilizer) and its performance is evaluated against physical and biological indicators, not expert interpretations of images or clinical data. "Ground truth" in this context would be the successful sterilization of materials as indicated by validated biological and physical methods.

4. Adjudication Method for the Test Set

Not applicable. (See explanation for point 3).

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 a medical device (steam sterilizer), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is a medical device, not an algorithm. The device's performance is inherently "standalone" in its sterilization function, without human-in-the-loop performance beyond operation and loading.

7. The Type of Ground Truth Used

The ground truth used for evaluating the performance of a steam sterilizer would typically be established through:

• Biological Indicators (BIs): Spore strips or vials containing highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) that, when cultured after a sterilization cycle, show no growth if sterilization was successful.
• Physical Indicators: Measurement of temperature, pressure, and time during the sterilization cycle using calibrated sensors to ensure parameters meet specified sterilization conditions.
• Chemical Indicators: Color-changing strips or tags that indicate exposure to steam and/or specific sterilization conditions, though these do not prove sterility alone.
• Load Specifications and Cycle Parameters: The "ground truth" and benchmark for performance are adhering to validated cycles and ensuring the device can consistently achieve these predefined, effective sterilization parameters for various loads (wrapped/unwrapped instruments, linens, liquids).

The document states, "Biological and physical testing was conducted," which aligns with the typical ground truth methods for these types of devices.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not a machine learning model, so there is no "training set" in the AI sense. The design and validation of the sterilizer are based on engineering principles and regulatory standards, not iterative training on a data set.

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

Not applicable. (See explanation for point 8).

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