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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

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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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Sakura Steam Sterilizer ASSV-AB-09 / Skytron Integrity 215 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AB09E / Skytron Integrity 215 SG Steam Sterilizer are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSV-AB-09 / Skytron Integrity 215 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AB09E / Skytron Integrity 215 SG 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 SKYTRON Integrity 215 Steam Sterilizer. SKYTRON Integrity 215 SG Steam Sterilizer, Sakura Steam Stenlizer ASSV-AB09, Sakura Steam Sterilizer ASSV-AB09E Steam Sterilizers are Class II, Product Code FLE Medical Devices as defined by CFR§880.6880 and defined for use in healthcare facilities. The SKYTRON Integrity 215 Steam Sterilizer, SKYTRON Integrity 215 SG Steam Sterilizer, Sakura Steam Sterilizer ASSV-AB09, Sakura Steam Sterilizer ASSV-AB09E 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.

This document is a 510(k) Summary for the SKYTRON Integrity 215 Steam Sterilizer and its variations. It focuses on the device's capabilities to sterilize instruments and materials in healthcare facilities. It does not describe an AI/ML device, therefore, the following requested information points are not applicable as they pertain to AI/ML device studies.

Therefore, I will provide the available information from the document regarding the device's acceptance criteria and the study conducted.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the steam sterilizers are defined by the factory-programmed sterilization cycle values, which indicate the maximum validated loads, sterilize temperature, sterilize time, and dry time for various cycles. The reported device performance is that these cycles were "validated according to ANSI/AAMI ST8: 2008" and that the device "passed all of the tests based on pre-determined Pass/Fail criteria."

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

The document does not explicitly state the "sample size" in terms of number of sterilization cycles or tests performed during validation. However, it mentions that "Efficacy of sterilizer function and exposure time recommendations are ultimately shown by complete kill of biological indicators and verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10^-6 reduction."

The data provenance is not specified beyond "Sakura Seiki Co., Ltd. validates its sterilization cycles by recommended practices, standards and guidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI)." The document also states the testing was "Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics" of the sterilizers. This suggests the data was collected specifically for validation purposes of this device, likely in a controlled, prospective manner, but the geographic origin of the testing is not detailed. The manufacturer is based in Japan.

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

This information is not provided. The efficacy is demonstrated by the "complete kill of biological indicators" to achieve a sterility assurance level (SAL) of at least 10^-6, which is a quantified scientific outcome, not dependent on expert consensus for ground truth.

4. Adjudication Method for the Test Set

This is not applicable as the validation focuses on objective performance measures (sterility assurance) rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

This is not applicable, as this is not an AI/ML diagnostic device with human readers.

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

This is not applicable, as this is not an AI/ML device. The device's "standalone" performance in a sense refers to its ability to sterilize independently, which was validated.

7. The Type of Ground Truth Used

The ground truth used for establishing the effectiveness of the sterilizer is based on biological indicators (BIs) and achieving a sterility assurance level (SAL) of at least 10^-6 reduction. This signifies that the probability of a viable microorganism remaining after sterilization is 1 in 1,000,000. This is an objective, scientifically established outcome. The validation also adheres to ANSI/AAMI ST8: 2008.

8. The Sample Size for the Training Set

This is not applicable, as this is not an AI/ML device that requires a "training set."

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

This is not applicable, as this is not an AI/ML device.

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