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The OER-Pro is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories. Safe use requires detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of the OER-Pro and Olympus flexible endoscopes and their accessories. Use of a detergent or high-level disinfectant/sterilant that has not been validated by Olympus may be ineffective and can damage the OER-Pro components and the endoscopes being reprocessed. Endoscopes must be subject to cleaning by the user prior to reprocessing; however, use of the OER-Pro enables the user to perform modified manual cleaning of the endoscope prior to automated cleaning and high-level disinfection in the OER-Pro.

The OER-Pro Endoscope Reprocessor is an automated endoscope reprocessor intended for high-level disinfection of Olympus flexible endoscopes and its accessories, utilizing both a detergent and FDA cleared high-level disinfectant validated by Olympus to be efficacious and compatible with the materials of the OER-Pro and Olympus flexible endoscopes and accessories.

The OER-Pro is a one-basin automatic endoscope reprocessor that performs leak test, cleaning, disinfection, rinse, and alcohol flush to render a high-level disinfected endoscope and accessories. The OER-Pro utilizes an immersion method for cleaning, disinfecting, and rinsing of endoscope and accessory external surfaces, and connectors for endoscope channel cleaning, disinfecting, and rinsing. Two endoscopes, with several exceptions, can be reprocessed simultaneously in the basin during one reprocessing cycle. The OER-Pro's cleaning cycle includes ultrasonic cleaning, which helps remove debris and dirt from endoscope surfaces.

The OER-Pro is capable of fully automated detergent/disinfectant solution dispensing and alcohol/air drying of endoscope channels. The 0.2-micron air/water filters are bacteria retentive and produce suitable rinse water and air for reprocessing. Built-in sensors detect fluid levels, fluid temperature, air/fluid pressure, and the operating states of the components within the OER-Pro.

The OER-Pro is also equipped with a RFID (Radio-Frequency Identification) function. With a built-in antenna, the OER-Pro is capable of reading user and scope ID data from the proprietary ID tag/chip. The scope/user ID information and each reprocessing result can be printed out with a built-in printer.

The OER-Pro is capable of either using a ready-to-use disinfectant (e.g., Aldahol) or a concentrated disinfectant (e.g., Acecide-C) sealed in dedicated cassette bottles. The concentrated disinfectant is automatically diluted by filtered water until specified quantity in the device. Only Olympus service engineers can switch the disinfection mode.

The document describes the OER-Pro Endoscope Reprocessor, an automated device for the cleaning and high-level disinfection of Olympus flexible endoscopes. It outlines various performance tests conducted to demonstrate the device's efficacy and safety.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "tests" and "testing" but does not explicitly state the specific sample sizes (number of endoscopes, cycles, or sites tested) for each validation study.

• Data Provenance: The studies are described as "simulated use" and "in-use" conditions. This implies prospective studies carried out to evaluate the device under controlled laboratory settings and, in the case of "in-use" testing, potentially in real-world clinical environments, though specific locations are not provided. The manufacturer is AIZU OLYMPUS CO., LTD., Japan, with the applicant/correspondent in the US (Olympus America Inc.). The testing was conducted to meet FDA guidance, so it's likely the tests were performed in a manner acceptable to the FDA, possibly at qualified facilities in the US or Japan.

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

The document does not specify the number or qualifications of experts involved in establishing ground truth for the test set. For cleaning and disinfection studies, ground truth typically involves microbiological cultures and chemical assays performed by trained laboratory personnel, rather than subjective expert opinion.

4. Adjudication method for the test set:

Not applicable. The tests described are objective performance evaluations (e.g., measuring microbial reduction, protein/hemoglobin levels, chemical residues) rather than assessments requiring human interpretation and adjudication.

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 reprocessor, not an AI-assisted diagnostic or imaging device that would involve human readers.

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

The studies described are standalone device performance studies, meaning they evaluate the OER-Pro's ability to clean and disinfect endoscopes autonomously, without human intervention as part of the primary reprocessing function. The cleaning and disinfection cycles are fully automated. However, it's important to note that the device's instructions for use state, "Endoscopes must be subject to cleaning by the user prior to reprocessing; however, use of the OER-Pro enables the user to perform modified manual cleaning of the endoscope prior to automated cleaning and high-level disinfection in the OER-Pro." This highlights that manual pre-cleaning is a critical human-in-the-loop step before the automated reprocessing by the device. The studies evaluate the device's performance given appropriate pre-cleaning.

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

The ground truth for the performance evaluations primarily relies on:

• Microbiological assays: For high-level disinfection and self-disinfection, a specific challenge organism (M. terrae) was used, and the ground truth was established by quantifying microbial reduction (e.g., 6 Log$_{10}$ reduction). "No viable microorganisms were recovered" also indicates microbiological cultural methods.
• Chemical assays: For cleaning validation, ground truth was based on measurements of protein and hemoglobin levels. For toxicological evaluation, ground truth was based on measurements of residual detergent and disinfectant to ensure they were below toxic levels.
• Physical parameter monitoring: For process parameter tests, ground truth was the observation and verification that the device maintained specified physical parameters (e.g., temperature, pressure, fluid levels).

8. The sample size for the training set:

Not applicable. This is a medical device for disinfection, not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for such a device involves engineering design, manufacturing, and calibration based on established scientific principles and prior knowledge of materials and processes.

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

Not applicable, as there is no training set in the context of AI/ML. The device's performance parameters are established through rigorous engineering design, material compatibility testing, and process validation, often based on industry standards and regulatory guidance for medical device reprocessing.

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