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RIS-311 is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a healthcare provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of medical and dental instruments that are validated to be sterm. The RIS-311 has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave.

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This document is a 510(k) clearance letter for a steam sterilizer (Lexa PLUS RIS-311), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI/ML specific aspects like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, and standalone performance is not applicable to this document.

The document describes the device's intended use and performance parameters in a table, but these are specifications for a physical sterilizer, not performance metrics for an algorithm.

Here's a breakdown of why each point is not applicable and what information is provided in the document for the physical device:

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

   • Not Applicable for AI/ML: This device is a steam sterilizer. Acceptance criteria would relate to its ability to sterilize, usually measured by biological indicators or physical parameters like temperature and pressure profiles, and device reliability.
   • Information in document: The table under "Indications for Use" lists operational parameters: Program type (Wrapped, Low Temperature, Unwrapped), Type of Load and Load Weight, Sterilization Temperature, Sterilization Time, and Drying Time (Recommended). These are the designed operating parameters of the sterilizer, not performance results against acceptance criteria in the AI/ML sense. For example, for "Wrapped" program, it has a Sterilization Temperature of 270 °F (132 °C) and Sterilization Time of 4 minutes.

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

   • Not Applicable for AI/ML: There is no "test set" in the context of an algorithm or data-driven model for this physical sterilizer. Performance validation for a sterilizer typically involves microbiology testing and engineering validation.
   • Information in document: None of this information is present as it's not relevant to a physical machine clearance.

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):

   • Not Applicable for AI/ML: No ground truth established by experts for a dataset.
   • Information in document: None.

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

   • Not Applicable for AI/ML: No adjudication of a test set.
   • Information in document: None.

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:

   • Not Applicable for AI/ML: An MRMC study is for evaluating human performance with and without AI assistance in interpretation tasks. This is a sterilization device.
   • Information in document: None.

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

   • Not Applicable for AI/ML: This refers to the performance of an AI algorithm alone. The Lexa PLUS RIS-311 is a physical machine.
   • Information in document: None.

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

   • Not Applicable for AI/ML: No ground truth in this context. Sterilizer validation relies on scientific principles of microbial inactivation and physical measurements.
   • Information in document: None.

8. The sample size for the training set:

   • Not Applicable for AI/ML: No training set for a data-driven model.
   • Information in document: None.

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

   • Not Applicable for AI/ML: No ground truth or training set for this device.
   • Information in document: None.

In summary, the provided text is a standard FDA 510(k) clearance letter for a medical device (a steam sterilizer) which operates based on physical principles, not AI/ML. Therefore, the questions posed, which are tailored for AI/ML device evaluations, do not apply.

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