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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 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 disinfect 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 the highest level of 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 provided text is a 510(k) Summary for the STERIS Reliance Endoscope Processing System. This document details the device, its intended use, and a comparison to a predicate device, along with a summary of non-clinical testing performed to demonstrate substantial equivalence.

Based on the provided information, I will answer the questions regarding acceptance criteria and the study that proves the device meets them.

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

2. Sample sized used for the test set and the data provenance

The document does not specify the exact sample sizes for the "selected worst-case duodenoscope models" or the number of medical devices used in biocompatibility testing. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. However, based on the context of a 510(k) submission for a medical device and the type of tests performed (e.g., efficacy, biocompatibility, stability), these would typically be controlled laboratory studies conducted prospectively.

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

The document does not provide information on the number of experts or their qualifications for establishing ground truth in these non-clinical tests. These types of tests (disinfection efficacy, biocompatibility, stability) are generally conducted by laboratory technicians and scientists following established protocols (e.g., ISO standards, AOAC methods) and do not typically involve human expert consensus for "ground truth" in the way a diagnostic AI system would. The "ground truth" for these tests is based on the measurable outcomes of the chemical and biological assays.

4. Adjudication method for the test set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation by multiple human readers. For the non-clinical laboratory tests described here (efficacy, biocompatibility, stability), an adjudication method is not applicable as the results are quantitative and based on predefined measurement thresholds.

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

No, an MRMC comparative effectiveness study was not done. The device in question is an automated endoscope processing system, which performs automated cleaning and high-level disinfection. It is not an AI-assisted diagnostic tool that aids human readers. Therefore, the concept of human readers improving with or without AI assistance does not apply here.

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

The primary tests reported are for the performance of the automated system itself (efficacy of disinfection, biocompatibility of the germicide, stability of the germicide). In this context, the "standalone" performance is precisely what was evaluated. The device functions automatically without a human actively making decisions based on its output during the disinfection process.

7. The type of ground truth used

For the efficacy test, the ground truth is the microbiological log reduction of Mycobacterium terrae following the disinfection process. For biocompatibility, the ground truth is cellular response (e.g., non-cytotoxicity) based on ISO 10993-5 standards. For stability, the ground truth is the chemical and functional properties of the germicide maintaining within acceptance criteria over time. These are all objective, measurable laboratory outcomes.

8. The sample size for the training set

The document describes non-clinical performance testing for a physical device (an automated endoscope reprocessor and its germicide). It does not involve machine learning or AI models with "training sets." Therefore, the concept of a training set size is not applicable.

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

As there is no training set involved for this type of device, this question is not applicable.

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