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Used for introduction of irrigation fluid into the gastrointestinal tract through the endoscope working channel.

The Accessory Irrigation Adapter is a non-sterile device that is compatible with endoscopes with a maximum working channel of 2.2 mm. The Accessory Irrigation Adapter is approximately 2 inches long.

This document is a 510(k) premarket notification for an "Accessory Irrigation Adapter." It describes the device and claims substantial equivalence to a predicate device. This type of regulatory submission historically focuses on bench testing to demonstrate performance, rather than clinical studies to evaluate diagnostic or therapeutic effectiveness.

Therefore, the input doesn't provide information about an AI/ML powered device, and the specifics requested in your prompt regarding acceptance criteria, study details, expert involvement, and ground truth are typically not part of a 510(k) submission for a non-diagnostic, non-therapeutic accessory like an irrigation adapter.

Based on the provided document, here's what can be extracted and what cannot:

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

   Acceptance Criteria	Reported Device Performance
   Functional user requirements met after accelerated aging. Such as:

• Able to insert through biopsy cap
• Able to irrigate through adapter
• Able to remove the adapter from working channel | Met. Non-clinical bench testing demonstrated that the Accessory Irrigation Adapter met the performance requirements to fulfill the intended use of the device after accelerated aging. |

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

   • Sample Size: Not specified in the provided text. The document refers to "performance testing consisting of non-clinical bench testing," but doesn't quantify the number of devices or tests performed.
   • Data Provenance: Not specified. This was non-clinical bench testing, not human data.

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 as typically defined for AI/ML diagnostic devices (e.g., expert consensus on images, clinical outcomes) is not relevant for this type of device's performance testing. The "ground truth" here is whether the device physically performs its function.

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

   • Not applicable. Adjudication methods are typically used for expert review of cases in diagnostic studies. For bench testing, success/failure is determined by whether the device meets pre-defined engineering and functional specifications.

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:

   • No, an MRMC study was not done. This device is an irrigation adapter, not an AI-powered diagnostic or therapeutic tool for which an MRMC study would be relevant.

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

   • Not applicable. This is a physical accessory and does not involve algorithms or AI.

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

   • Not applicable in the context of diagnostic/AI ground truth. For this device, the "ground truth" is its functional performance determined by engineering specifications and bench tests (e.g., the ability to insert, irrigate, and remove).

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no training set.

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

   • Not applicable. This is not an AI/ML device, so there is no training set or its associated ground truth establishment.

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