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Sakura Steam Sterilizer ASSV-AH06 / Skytron Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E / Skytron Integrity 175 SG Steam Sterilizers are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSV-AH06 / Skytron Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E / Skytron Integrity 175 SG Steam Sterilizers incorporate high-pressure steam to sterilize non-porous and porous, heat and moisture-stable items and materials used in the health care facilities.

Sakura Steam Sterilizer ASSV-AH06, SKYTRON Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E and SKYTRON Integrity 175 SG Steam Sterilizers are Class II, Product Code FLE Medical Devices as defined by CFR§880.6880 and defined for use in healthcare facilities. Sakura Steam Sterilizer ASSV-AH06, SKYTRON Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E and SKYTRON Integrity 175 SG Steam Sterilizers 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 ASSV-AH06, SKYTRON Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E, and SKYTRON Integrity 175 SG Steam Sterilizers were validated to meet the requirements of ANSI/AAMI ST8:2008.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are the performance specifications for each sterilization cycle, as outlined in the "Maximum Validated Loads," "Sterilize Temp," "Sterilize Time," and "Dry Time" columns. The reported device performance is that the "device passed all of the tests based on predetermined Pass/Fail criteria."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample size used for the test set for each validation activity. It broadly states that "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics" and that "the device passed all of the tests." The validation was performed according to ANSI/AAMI ST8:2008, a standard for steam sterilization. The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data mentioned, though 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 (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The validation relied on adherence to recommended practices, standards, and guidelines from organizations like AAMI, rather than human expert consensus on specific cases. The "ground truth" for sterilization devices is typically based on the complete kill of biological indicators and verification of a specified sterility assurance level (SAL).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and therefore not provided, as the validation method described does not involve human adjudication of results in the traditional sense of medical image analysis or similar diagnostic tasks. The efficacy is based on objective measurements related to the destruction of biological indicators.

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 to the device described (a steam sterilizer). MRMC studies are typically performed for diagnostic devices where human readers interpret output, often with AI assistance. This device sterilizes medical instruments, and its performance is measured by its ability to sterilize, not by human interpretation.

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

Yes, the testing described appears to be a standalone performance evaluation of the sterilizer itself, without a human-in-the-loop component for its primary function (sterilization). The device's efficacy is demonstrated by its ability to achieve a complete kill of biological indicators and a specified sterility assurance level.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for validating the sterilizer's effectiveness is based on the complete kill of biological indicators and verifying an appropriate sterility assurance level (SAL) of at least 10^-6 reduction. This is a microbiological standard, not expert consensus, pathology, or outcomes data related to patient diagnosis.

8. The sample size for the training set

This information is not applicable. The device is a steam sterilizer, not an AI/ML algorithm that requires a training set in the conventional sense. The "software validation" mentioned was performed according to FDA guidance for "Software Contained in Medical Devices," which focuses on verifying software functionality and safety, not on training an algorithm with data.

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

This information is not applicable, as there is no "training set" for this type of medical device. The validation process ensures the device meets predefined sterilization standards.

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