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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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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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