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The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as bronchoscopes, GI flexible endoscopes including duodenoscopes, and their accessories. High level disinfection is achieved within the 50-57°C HLD phase of the endoscope processing cycle (4-minute generation sequence followed by a 6-minute exposure sequence).

The Reliance Endoscope Processing System is a high level disinfection system that can wash and high level disinfects up to two manually precleaned, immersible, reusable, heatsensitive, semi-critical devices such as GI flexible endoscopes and related accessories. The system utilizes Reliance™ DG Dry Germicide, a proprietary, safe, and dry peracetic acid generating oxidative chemistry. The Reliance Endoscope Processing System was designed to be versatile in meeting the growing demands of the modern flexible endoscope processing department, while offering patient and staff safety. The Reliance Endoscope Processing System is a combination of products that are used to wash and high level disinfect flexible endoscopes and their accessories.

• The Reliance Endoscope Processor is an electromechanical washer/high level disinfector with a microprocessor-based controller that provides for automated endoscope processing cycles and processor self-decontamination cycles.
• Reliance DG Dry Germicide is a proprietary, two-part, dry, single-use oxidative chemistry, designed to generate the high level disinfection solution upon automatic dilution in water within the Reliance Endoscope Processor.
• Optional washing is provided through the automated delivery of Klenzyme Enzymatic Presoak and Cleaner during the wash phase of the cycle.
• CIP 200 Acid-Based Process and Research Cleaner, a general cleaning agent, is used in one of the two self-decontamination cycles provided by the processor.
• Various accessories are available to accommodate the processing needs of specific endoscopes and endoscopic accessories.
• VERIFY Reliance CI Process Indicator is available to monitor for the presence of the Reliance DG active ingredient, peracetic acid.

The provided document is a 510(k) summary for the STERIS Reliance Endoscope Processing System. It outlines the device's indications for use, technological characteristics, and a summary of non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Key takeaway for your request: This document primarily focuses on showing the equivalence of a slightly modified device (due to a raw material change) to an already cleared predicate device. It is not a study demonstrating the initial performance acceptance criteria for the original device for the purpose of a device efficacy study in terms of AI performance. The device in question is an endoscope reprocessing system, not an AI-powered diagnostic device. Therefore, a significant portion of your requested information, particularly relating to AI performance, ground truth, expert readers, and MRMC studies, is not applicable to this document.

However, I can extract the acceptance criteria and performance results directly from the provided Table 3, which summarizes the new testing performed for this 510(k) submission (related to a raw material change).

Here's the relevant information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify quantitative sample sizes for the "Fit test," "Technical specifications," or "Biocompatibility and Chemical Compatibility" evaluations. These typically involve material evaluations, bench testing, and potentially a limited number of device assemblies rather than large-scale patient-based test sets as would be seen for an AI diagnostic.
• Data Provenance: The document does not explicitly state the country of origin for this specific testing data beyond it being a submission to the U.S. FDA by a company based in Mentor, Ohio, USA. The testing would have been conducted by or for STERIS Corporation. The nature of these tests (material properties, component fit, chemical compatibility) suggests laboratory or manufacturing facility-based evaluations, not clinical data. The document indicates this was non-clinical testing (Page 12, Section 6).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This document pertains to the mechanical, chemical, and material compatibility performance of an endoscope processing system, not an AI diagnostic device that requires expert-established ground truth from images or other medical data.

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

• Not Applicable. As above, this type of adjudication is relevant for human interpretation of medical data (e.g., radiology reads), not for the engineering and material performance tests described.

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. This device is an automated endoscope reprocessing system, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant for this type of device.

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

• Not Applicable. This device does not involve an AI algorithm; it is a physical system for high-level disinfection of endoscopes.

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

• For the tests conducted (Fit test, Technical specifications, Biocompatibility/Chemical Compatibility), the acceptance criteria inherently define the "truth." For example, for "Fit test," the ground truth is simply whether the components physically fit and function as intended without interference, consistent with the original design. For "Technical specifications," it's comparison to established material specifications. For "Biocompatibility/Chemical Compatibility," it's compliance with ISO standard requirements for non-cytotoxicity and resistance to the processing chemicals. These are not clinical "ground truths" in the diagnostic sense.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device; therefore, there is no training set.

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

• Not Applicable. As there is no training set for an AI model, this question is not relevant.

In summary, the provided document is a regulatory submission for an endoscope reprocessing system, focusing on demonstrating substantial equivalence after a minor material change. It does not involve AI or diagnostic imaging, and therefore, most of the requested information regarding AI performance testing (MRMC, standalone performance, expert ground truth) is outside the scope of this document.

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