Search Results

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.

Ask a specific question about this device