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The Amsco 400 Small Steam Sterilizer models 16, 16C, 16CS, 16S, 20, 20CS, and 20S are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

• Prevacuum (Models 16, 16C and 20, 20C) – are equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
• Steam Flush Pressure-Pulse (SFPP) (Models 16CS, 16S and 20CS, 20S) are equipped with SFPP, . Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

The AMSCO 400 Medium Steam Sterilizers (Models 39SL and 39CSL) are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configuration:

• Prevacuum equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

The AMSCO 400 Medium Steam Sterilizers (Models 36H, 48H, 60H, 36SL, 48SL, 60SL, 36CH, 48CH, 60CH, 36CSL, 48CSL and 60CSL) are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configuration:

• Prevacuum - equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles

The AMSCO 400 Steam Sterilizers are the same as the predicate devices except for the specific modifications described in this submission. There are no differences in the indications for use or technology (including features and principles of operation) between the proposed and predicate devices. Therefore, the differences between the proposed and predicate devices are limited to the described modifications, and these proposed changes raise no new concerns of safety and effectiveness when compared to the predicate device.

The provided document is a 510(k) summary for STERIS AMSCO 400 Small and Medium Steam Sterilizers. It describes the device, its intended use, and a summary of nonclinical tests performed to demonstrate substantial equivalence to predicate devices.

Key takeaway: This document is NOT about an AI/ML powered medical device. It's about a steam sterilizer that underwent a modification to replace an obsolete control chip. The performance testing described is related to ensuring the sterilizer still functions as intended and meets safety and functional requirements, not evaluating an AI algorithm's diagnostic or predictive capabilities.

Therefore, most of the requested information regarding AI/ML device acceptance criteria and study design (e.g., sample size for test set, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth for training set) is not applicable to this document.

However, I can extract the acceptance criteria and performance data related to the sterilizer's functionality.

Acceptance Criteria and Reported Device Performance (Table for Sterilizer Functionality)

The core acceptance criterion for this device modification is demonstrating that the updated sterilizer performs as safe, as effective, and performs as well or better than the legally marketed predicate device. This is assessed by ensuring all safety and functional tests related to the software (which controls the sterilizer) pass.

Inapplicability of AI/ML Specific Information for this Device (due to device type):

1. Sample size used for the test set and the data provenance: Not applicable in the context of AI/ML. For this device (steam sterilizer), testing involves functional performance validation. The document states "Performance testing to demonstrate substantial equivalence to the predicate, using the same methods as were used to validate the original design." The exact number of test cycles or sterilization runs is not specified in this summary but would be part of the full validation report.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a sterilizer's function would be objective measurements (temperature, pressure, time) and sterility indicators, not expert consensus on interpretations.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. This is not an AI-assisted diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The "software validation" is for the control system of a physical device, not a standalone algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a steam sterilizer, ground truth would be established through objective measures like:
   • Biological indicators (presence/absence of microbial growth after sterilization).
   • Chemical indicators (changes in color/form indicating exposure to sterilization conditions).
   • Physical monitoring (temperature and pressure sensors within the sterilizer chamber matching specified cycle parameters).
7. The sample size for the training set: Not applicable. There is no AI/ML training involved.
8. How the ground truth for the training set was established: Not applicable. There is no AI/ML training involved.

In summary, the provided document relates to a traditional medical device (steam sterilizer) undergoing a minor modification (chip replacement) and its regulatory clearance based on demonstrating continued performance equivalence to predicate devices, rather than an AI/ML-powered device. Therefore, the detailed questions about AI/ML specific study design are not addressed in this document.

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