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B CLASSIC-17 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

B CLASSIC-22 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

B FUTURA-17 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

B FUTURA-22 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

The Family of steam sterilizers B17 B22 series includes table-top steam sterilizers that use saturated steam at high pressures and temperatures to kill infectious bio-organisms. The Classic and B Futura models differ only for some minor characteristics such as color touchscreen, optional Wi-FI connection, illumination of the working area and Ethernet connection. The steam is generated by a steam generator connected to the sterilization chamber without disconnecting devices. An electric heating element surrounds the chamber for preheating of the chamber and maintaining the temperature. The subject family is characterized by a fractionated vacuum system for the complete air removal also from hollow and porous materials as well as by a final vacuum drying phase able to eliminate any trace of condensation from the load.

This document pertains to the FDA 510(k) premarket notification for a new family of steam sterilizers (B17 B22 Series) and compares them to a legally marketed predicate device (Family of Steam sterilizers B28 series, K151597). The information provided focuses on the physical and performance characteristics of mechanical steam sterilizers, not on AI/ML-driven diagnostic devices. Therefore, a direct response to the requested information regarding AI/ML device acceptance criteria and study details (like sample size for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth, etc.) cannot be extracted from this document.

However, I can extract the acceptance criteria for the steam sterilizer's performance and the reported device performance based on the provided text, as these are the "study" and "acceptance criteria" applicable to this specific type of medical device.

Key Findings for Steam Sterilizer Device Performance and Acceptance:

The document demonstrates substantial equivalence to a predicate device (CEFLA S.C. Family of Steam sterilizers B28 series, K151597) by meeting the requirements of ANSI/AAMI ST55:2010 for table-top steam sterilizers.

Here's a table of acceptance criteria and reported device performance for this steam sterilizer:

Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/ML-specific questions, based only on the provided document:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   • This information is not applicable to a steam sterilizer. The "test set" here refers to specific loads and operational conditions for validating sterilization efficacy, not data for an AI model. Data provenance (country, retrospective/prospective) is not mentioned for the performance tests, as these are lab-based validations.
2. 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):
   • Not applicable. Ground truth for a sterilizer is established through universally accepted microbiological standards (e.g., SAL, biological indicators) and physical measurements (temperature, pressure, leak rates) according to standards like AAMI ST55. It does not involve human expert interpretation in the way AI/ML diagnostic tools do.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   • Not applicable. Adjudication methods are relevant for human interpretation outcomes, not for the objective readings of physical and biological indicators in a sterilizer.
4. 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, as this is not an AI/ML diagnostic device with human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   • Not applicable, as this is not an AI/ML device. The device operates as a standalone sterilizer, and its performance is evaluated independently of human intervention during the cycle.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
   • The ground truth for this device is based on microbiological sterility (absence of viable microorganisms, confirmed by biological indicators) and physical parameters (temperature, pressure, vacuum, moisture retention) measured against established industry standards (ANSI/AAMI ST55:2010).
7. The sample size for the training set:
   • Not applicable, as this is not an AI/ML device.
8. How the ground truth for the training set was established:
   • Not applicable, as this is not an AI/ML device.

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