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The Irrigation Pump and Irrigation Biopsy Valve System is intended to provide a manual, foot-controlled delivery of fluid from commercially available sterile water bottles to flexible gastrointestinal endoscopes to facilitate the irrigation and lavage of debris within the gastrointestinal tract.

The Irrigation Pump is intended as a disposable, manual, foot-controlled, irrigation pump with a bottle cap and back-flow valve that delivers fluid from sterile water bottles.

The Irrigation Biopsy Valve is intended as a disposable, replaceable valve that connects the Irrigation Pump to the accessory channel of a flexible, endoscope.

Device Description

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "US Endoscopy Irrigation Pump and Valve System". This document details the regulatory submission and approval for a medical device, not a diagnostic algorithm or AI product. Therefore, many of the requested categories in your prompt are not applicable to this type of submission.

Here's an analysis based on the available information:

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

The submission does not explicitly list "acceptance criteria" in the way one would for a diagnostic algorithm with performance metrics like sensitivity, specificity, or AUC. Instead, the device's acceptable performance is demonstrated through its design characteristics, comparison to predicate devices, and functional bench testing.

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness for Intended Use	Substantially equivalent to predicate devices based on design, comparison, and performance testing.
Biocompatibility	All components that come into indirect contact with the patient have a long history of use in medical devices and are biocompatible.
Functional Bench Testing	Performance testing consisted of functional bench testing (details not provided in the summary).
No Direct Patient Contact	No components come into direct contact with the patient.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This device is an irrigation pump and valve system, not a diagnostic software that uses a "test set" of patient data. The "testing" referred to is functional bench testing of the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. "Ground truth" in the context of diagnostic algorithms refers to a verified diagnosis or outcome. For this device, performance is evaluated through engineering and functional tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no expert adjudication for this type of device submission.

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 is not an AI or diagnostic imaging device that involves human readers.

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 a standalone algorithm.

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

Not applicable. For this device, "ground truth" would be related to its functional specifications (e.g., fluid delivery rate, pressure, leak integrity) which are assessed through engineering tests, not clinical "ground truth" data.

8. The sample size for the training set

Not applicable. No "training set" is used for this type of medical device submission.

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

Not applicable.

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