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Sakura Steam Sterilizer ASSR-AO12, ASSR-AO12W, ASSR-AO12P and ASSR-A012PW / Skytron Integrity 270 and 270 VP Steam Sterilizer are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSR-A012. ASSR-AO12W, ASSR-AO12P and ASSR-AO12PW / Skytron Integrity 270 and 270 VP Steam Sterilizer incorporate high-pressure steam to sterilize non-porous and porous, heat and moisture-stable items and materials used in the health care facilities.

The Sakura Steam Sterilizer ASSR-A012, Sakura Steam Sterilizer ASSR-A012W, Sakura Steam Sterilizer ASSR-A012P, Sakura Steam Sterilizer ASSR-AO12PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizer, are Class II, Product Code FLE Medical Devices as defined by CFR§880.6880 and defined for use in healthcare facilities. The Sakura Steam Sterilizer ASSR-A012. Sakura Steam Sterilizer ASSR-A012W. Sakura Steam Sterilizer ASSR-A012P. Sakura Steam Sterilizer ASSR-AO12PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizer provide efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The sterilizers also dry items that have been sterilized with wet steam.

The Sakura Steam Sterilizer models ASSR-A012, ASSR-A012W, ASSR-A012P, ASSR-A012PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizer are assessed for safety and effectiveness through non-clinical testing and comparison to a predicate device.

1. A table of acceptance criteria and the reported device performance:

The acceptance criterion for sterilization efficacy is a Sterility Assurance Level (SAL) of <10^-6, meaning less than one in one million probability of a viable microorganism after sterilization. The devices were validated according to the ANSI/AAMI ST8: 2008 standard.

2. Sample size used for the test set and the data provenance:

The document describes "complete kill of biological indicators" but does not specify the sample size for the biological indicator tests. The data provenance is primarily from non-clinical verification, validation, and testing activities conducted by Sakura Seiki Co., Ltd. The context suggests these are prospective tests performed on the manufactured devices. The manufacturer is based in Japan.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the summary. The ground truth for sterilization efficacy is established by verifying the complete kill of biological indicators and achieving an SAL of <10^-6, which typically relies on microbiological testing rather than expert consensus on individual cases.

4. Adjudication method for the test set:

This information is not applicable for this type of device and study. The validation process involves laboratory testing with biological indicators against a predefined standard (ANSI/AAMI ST8: 2008), not human adjudication of results.

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:

This is not applicable. The device is a steam sterilizer, a medical device for sterilization, not an AI-assisted diagnostic tool. Therefore, MRMC studies and assessment of human reader improvement with AI assistance are irrelevant to its evaluation.

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

This is not applicable in the context of AI algorithms. However, in the context of device performance, the sterilizer's function is standalone, performing sterilization cycles autonomously. Its efficacy is assessed independently of human intervention during the sterilization process itself, once programmed and initiated.

7. The type of ground truth used:

The ground truth for the effectiveness of the sterilization process is established by:

• Complete kill of biological indicators: This is a direct microbiological measure of sterilization efficacy.
• Sterility Assurance Level (SAL) of <10^-6: This is a universally accepted standard for sterilization, verified through biological indicator testing.
• Compliance with ANSI/AAMI ST8: 2008: This industry standard dictates the methodologies and criteria for validating steam sterilization cycles.

8. The sample size for the training set:

This is not applicable. The device is a steam sterilizer, not a machine learning model. There is no concept of a "training set" for such a device.

9. How the ground truth for the training set was established:

This is not applicable for the same reason as above. The device does not utilize a training set in the machine learning sense. The ground truth for its performance is established through rigorous validation and testing against pre-defined industry standards and performance requirements using biological indicators.

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