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The Dragonfly Pancreaticobiliary Scope is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.

The Dragonfly Digital Controller is intended to provide illumination power and receive, process and output images from the Dragonfly Pancreaticobiliary Scope for diagnostic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.

The Dragonfly Instrument Channel Caps are used to cover the biopsy/suction channel inlet of an Olympus®, Fujifilm® or Pentax® duodenoscope. The Instrument Channel Caps are intended for exclusive use with the Dragonfly Pancreaticobiliary Scope to provide access for passage, while maintaining leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.

The Dragonfly Pancreaticobiliary Scope is a sterile, single-use endoscope used for singleoperator per-oral 2holoangiopancreatoscopy. The Dragonfly Pancreaticobiliary System is comprised of two components: The Dragonfly Pancreaticobiliary Scope and the Dragonfly Digital Controller.

The Dragonfly Pancreaticobiliary Scope System is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. The Dragonfly Pancreaticobiliary Scope is a single-use catheter which provides direct visualization with a camera and illumination, and enables access and delivery of accessories to targeted pancreaticobiliary anatomy. The Dragonfly Pancreaticobiliary Scope comprises of a handle, a catheter, imaging and illumination elements, and a video connection mechanism. The Dragonfly Digital Controller is a reusable accessory which controls illumination and receives, processes, and outputs video signals from the Dragonfly Pancreaticobiliary Scope. The system does not treat or diagnosis conditions.

The Dragonfly Instrument Channel Caps, which are included in package with the Dragonfly Pancreaticobiliary Scope, are used to cover the opening to the biopsy/suction channel inlet of a Olympus®, Fujifilm® or Pentax® duodenoscope. The Instrument Channel Caps are intended for exclusive use with the Dragonfly Pancreaticobiliary Scope to provide access for passage, while maintaining insufflation and minimizing leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.

This document is a 510(k) summary for the Dragonfly™ Pancreaticobiliary Scope, Digital Controller, and Instrument Channel Caps. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report of the new device's performance against specific acceptance criteria. This type of regulatory submission typically does not include the level of detail requested in your prompt regarding specific acceptance criteria, test set characteristics, expert involvement, or training data for AI/ML-based devices.

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

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

The document lists performance tests conducted, implying that the device passed these tests. However, it does not explicitly state specific quantitative acceptance criteria for each test. Instead, it broadly states "All testing was performed on test units representative of finished devices. The device passed the following tests."

Here's a table based on the types of tests performed, as specific numerical acceptance criteria are not provided:

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

The document states, "All testing was performed on test units representative of finished devices." However, it does not specify the sample size for any of the tests, nor does it provide information on data provenance (e.g., country of origin, retrospective/prospective nature). These tests are generally laboratory-based device performance tests, not clinical studies involving patient 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)

This information is not provided in the document. The listed tests are engineering and performance validation tests for a physical medical device, not AI/ML algorithm performance studies that would require expert-established ground truth. Expert involvement in defining test methods or interpreting results would be part of the manufacturer's internal quality system, but is not detailed here.

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

This information is not provided. Given the nature of the tests (engineering and device performance), formal adjudication methods like 2+1 or 3+1, which are common in clinical trial or AI model validation, are not typically applicable or detailed in this type of 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

The document does not mention or imply that an MRMC comparative effectiveness study was done. The device is an endoscope system, not an AI-assisted diagnostic tool. Therefore, the question about human reader improvement with AI assistance is not relevant to this submission.

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

The document does not describe any standalone algorithm performance testing, as the device is a medical imaging and intervention tool, not an AI/ML algorithm.

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

For the physical device performance tests listed (e.g., dimensional verification, image quality, electrical safety), the "ground truth" is typically defined by engineering specifications, relevant international standards (e.g., ISO, IEC), and internal design requirements. This is not explicitly defined as expert consensus, pathology, or outcomes data in the context of this submission.

8. The sample size for the training set

This information is not provided. There is no indication in the document that the device incorporates an AI/ML component requiring a training set.

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

This information is not provided, as there is no mention of a training set or AI/ML components for which ground truth would need to be established.

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