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System 83 Plus™ Washer/Disinfector is designed for the simultaneous high level disinfection of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. Flexible endoscopes that are precleaned and manually cleaned, and then exposed to the washing /disinfection cycle of the System 83 Plu s™, may be high level disinfected when the disinfection cycle corresponds to the System 83 Plus™ validated contact conditions of the high level disinfectant.

Note: The System 83 Plus™ device includes two models.

· The System 83 Plus™ 2 has one processing chamber that can process 1 to 2 flexible endoscopes at a time .

· The System 83 Plus™ 9 has two processing chambers that can process 1 to 2 flexible endoscopes at a time in each independently operated processing chamber for a total of up to 4 endoscopes simultaneously.

The System 83 Plus™ is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes (per bay) utilizing a detergent and FDA cleared high-level disinfectant validated by CUI. The System 83 Plus™ device family includes two models. The System 83 Plus™ 2; a model with one processing chamber, which can process one to two flexible endoscopes at a time. The System 83 Plus™ 9: a model with two processing chambers which can asynchronously reprocess up to 2 endoscopes per bay (total of up to 4 endoscopes).

The System 83 Plus™ utilizes a processing chamber and the immersion method to perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high level disinfected endoscope. The System 83 Plus™ is capable of automated detergent dispensing and transfer of disinfectant solution between the reservoir and processing chamber. Following disinfection, the endoscopes and channels are automatically rinsed with potable water that is filtered through a water filtration system that contains a 0.1 micron bacteria filter and the channels are then flushed with air. A semi-automated air/alcohol flush must be completed at the end of the cycle. At completion, the operator prints out the endoscope reprocessing information with a printer.

Built-in sensors detect fluid levels, fluid temperature, fluid flow, and the operating states of the components within System 83 Plus™.

The provided text is a compilation of FDA documents related to the 510(k) premarket notification for the "System 83 Plus Washer/Disinfector." It describes the device, its intended use, comparison to a predicate device, and a summary of non-clinical testing performed to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The Scope-Assist Flushing Sink is indicated for flushing the channels of flexible endoscopes according to the endoscope manufacturer's instructions.

The Scope-Assist Flushing Sink is designed to mechanically assist the channel flushing portion of an endoscope's manual cleaning process. The sink facilitates compliance with endoscope manufacturer's cleaning requirements by:
• Providing a means of flushing flexible endoscope channels with detergent solution
• Providing a means of flushing endoscope channels with water
• Providing an environment for soaking and manual wiping/brushing of flexible endoscope exterior surfaces and accessories
• Providing an environment to perform wet leak testing of endoscopes
The Scope-Assist Flushing Sink is designed:
• To be used where the facility performs its endoscope cleaning functions, such as in soiled utility rooms, central processing decontamination areas, or endoscope cleaning (reprocessing) areas.
• To be used with Tergal 800 Detergent
The Scope-Assist Flushing Sink is not designed:
● To be used at bedside, in critical care units, or in sterile environments
● To be used as a terminal process or as part of the manual high level disinfection process

This document describes a 510(k) premarket notification for the "Scope-Assist Flushing Sink" device. It is a device intended to mechanically assist the channel flushing portion of an endoscope's manual cleaning process. The information provided is for regulatory approval and does not contain a study of the type you're asking for (e.g., related to AI or diagnostic accuracy improvements). Therefore, many of your requested items regarding acceptance criteria and study details cannot be answered based on this document.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

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

This document describes performance testing for a medical device (a flushing sink), not a diagnostic or AI algorithm. Therefore, the concept of a "test set" in the context of data (like medical images or patient records) does not apply here. The testing would have involved physical devices and potentially endoscopes, but no sample size or data provenance is specified in terms of clinical or image data.

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

Not applicable. This is a physical device, and ground truth in the context of expert review for data is not part of this submission. The "ground truth" would be established by engineering specifications and industry standards for flushing efficacy.

4. Adjudication method for the test set:

Not applicable. No expert adjudication process for a data test set is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, What was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a physical medical device, not an AI or diagnostic tool that would involve human readers or MRMC studies.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

For the performance tests described (flushing, detergent injection, compatibility), the "ground truth" would likely be derived from:

• Endoscope manufacturer's instructions/specifications: for required flushing volumes, times, and cleaning protocols.
• Engineering specifications and standards: for detergent delivery accuracy, material compatibility.
• International standards (IEC 61010-1, IEC 60601-1-2): for electrical safety and electromagnetic compatibility.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable. This is a physical medical device, not an AI algorithm.

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