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The Andorate® Disposable biopsy valve is used to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

The Andorate® Disposable Biopsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.

The biopsy valve is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

The biopsy irrigator is intended to cover the endoscope biopsy port for sealing and endoscopic device passage/ exchange, at the same time use in conjunction with irrigation tubing. consists of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the irrigation tubing.

The biopsy irrigator and biopsy valve are packed individually in a sealed packed. The subject devices are supplied as sterile The subject devices in this submission have the same operation and method of action with the predicate devices.

The provided text is a 510(k) Premarket Notification for the Andorate Biopsy Valve and Andorate Biopsy Irrigator, seeking substantial equivalence to existing predicate devices. It describes the devices, their intended use, technological characteristics, and performance data. However, this document does not describe a study involving a medical device that uses AI or machine learning algorithms, nor does it contain information about expert ground truth establishment, reader studies, or training/test sets for such algorithms.

The document details the acceptance criteria and study proving the devices meet these criteria for mechanical and material performance of traditional medical devices. Therefore, I will extract information relevant to those types of devices based on the provided text.

Here's the information parsed from the document for the Andorate Biopsy Valve and Andorate Biopsy Irrigator:

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

The document outlines performance tests conducted for each device. The reported performance is that the tests were conducted and the results imply that the subject devices provide and maintain a sterile barrier and their intended performance before the expiration date, and that they support safety and efficacy, and substantial equivalence to predicate devices. Specific quantitative acceptance criteria values are not provided in this summary, but rather the types of tests performed.

Andorate® Disposable Biopsy Valve:

Andorate® Disposable Biopsy Irrigator:

General Performance Criteria (Both Devices):

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

The document states that the bench testing was performed on "subject devices from initial production lots, including sterilization." It does not specify the exact sample size (number of devices) used for each test. The data provenance is implied to be from internal testing by GA Health Company Limited, likely from their production facility in Hong Kong, China (per Submitter's Address). The studies are retrospective in the sense that they are performed on manufactured products to demonstrate existing properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

Information for points 3-9 cannot be provided from the given text. This document describes the 510(k) premarket notification for traditional mechanical medical devices (biopsy valves and irrigators), not a device incorporating Artificial Intelligence (AI) or machine learning. Therefore, concepts like expert ground truth, reader studies, training sets, test sets for algorithms, and standalone AI performance are not relevant to the described studies and are not mentioned in the document. The "ground truth" for these devices is established through engineering and material science bench testing, confirming physical and functional properties against predefined specifications, rather than clinical interpretation. Clinical testing was explicitly stated as "not necessary to support substantial equivalence data."

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