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The Pancreaticobiliary Video System consists of PB Digital Controller and Single-use Video Pancreaticobiliary Scope.

The Single-use Video Pancreaticobiliary Scope is used in combination with the PB digital controller, which is designed to provide imaging for the diagnosis and treatment application of endoscopic surgery process of pancreatic biliary system, and provide working channel for other diagnosis and treatment accessories.

The PB Digital Controller can be used together with the Single-use Video Pancreaticobiliary Scope of Micro-Tech to process the image collected by the scope and transmit it to the display.

Pancreaticobiliary Video System consists of:

Single-Use Video Pancreaticobiliary Scope:

• CDS11001
• CDS11002
• CDS11003
• CDS11004
• CDS11005
• CDS22001 ●
• CDS22002
• CDS22003
• CDS22004
• CDS22005

PB Digital Controller:

• BS-W-100

The Single-Use Video Pancreaticobiliary Scope is a sterile single use flexible scope and PB Digital Controller is a reusable device.

The Single-Use Video Pancreaticobiliary Scope has the following physical and performance characteristics:

• Maneuverable tip controlled by the user
• Insertion port
• Suction port
• Camera at the distal tip and LED light source in the handle of the pancreaticobiliary scope

The light emitted by the cold light source located in the handle is transmitted to the distal end of the pancreaticobiliary scope through the glass fiber, and irradiates the human tissue from the distal end. CMOS and glass fiber are located at the same position at the distal end. CMOS transmits the collected image information to the PB Digital Controller through cable, and the PB Digital Controller displays the image on the display after processing.

CMOS and optical components are identical for all specifications of products.

• Working channel port
• Lever which can lock the control

The Single-Use Video Pancreaticobiliary Scope have different size as follows:

• Maximum insertion portion width
• Effective working length
• Minimum accessories channel width

The PB Digital Controller has the following physical and performance characteristics:

• Displays the image from The Single-Use Video Pancreaticobiliary Scope on the screen
• Can record screenshots or video of image from the Single-Use Video Pancreaticobiliary Scope
• Can connect to an external monitor
• Reusable device

The provided text describes a 510(k) summary for the Micro-Tech (Nanjing) Co., Ltd.'s Single-use Video Pancreaticobiliary Scope and PB Digital Controller. This is a premarket notification for a medical device seeking substantial equivalence to existing devices, not a study proving an AI device meets acceptance criteria.

The document discusses bench testing to demonstrate the performance of the proposed device against a predicate, but it does not involve an AI device or a study structured to prove an AI's performance against specific acceptance criteria, including human expert evaluation.

Therefore, I cannot extract the information required by your prompt, such as acceptance criteria for an AI device, sample sizes for AI test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, or training set details.

The relevant sections of the document explicitly state:

• "No animal study is included in this submission."
• "No clinical study is included in this submission."

This indicates that clinical (human) performance data, which would be crucial for evaluating an AI device's effectiveness, was not part of this submission for market clearance. The "Performance Data" section (page 10-11) lists a series of bench tests for physical and electrical characteristics of the scope and controller, not for an AI algorithm.

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The SpyGlass Discover Retrieval Basket is indicated for the endoscopic removal of stones and stone fragments in the biliary system.

The SpyGlass Discover Retrieval Basket is designed to be used with the SpyGlass Discover Digital Catheter (K200483), which is a single-use endoscope. The SpyGlass Discover Retrieval Basket is a self-expanding nitinol wire basket that is housed within a flexible sheath. The basket is extended from the sheath (opened) and retracted into the sheath (closed) using a thumb slide on the proximal handle. The basket cage is made of four nitinol wire legs. The basket wires are looped at the distal end featuring a tipless design with no exposed wire ends.

The provided text is a 510(k) summary for the Boston Scientific SpyGlass™ Discover Retrieval Basket. This document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. As such, it primarily focuses on demonstrating equivalence through comparison of technical characteristics and performance data, rather than detailing a clinical study with human subjects, acceptance criteria for an AI/algorithm, or MRMC studies that would be typical for an AI-powered diagnostic device.

Therefore, the information requested in your prompt regarding acceptance criteria for an algorithm, study design elements like sample size for training/test sets, expert adjudication, or MRMC studies, and ground truth establishment is not present in this document. This document describes a physical medical device (a retrieval basket), not a software or AI-based diagnostic tool.

However, I can extract the acceptance criteria and performance data for the physical device's bench testing, as described in Section 7, "Performance Data."

Here's a breakdown based on the information available:

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

The document describes various bench tests conducted to evaluate the device. The specific acceptance criteria values and the quantitative results are not explicitly stated in a table format with numerical values within this summary. However, the types of tests and the implicit acceptance criteria (that the device performs acceptably for its intended use and is comparable to the predicate) are listed.

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

• Sample Size: Not specified for individual bench tests. The document generically states "Testing includes:" and then lists the tests.
• Data Provenance: The testing was "Non-clinical performance bench testing and simulated use testing" performed by Boston Scientific Corporation. This is laboratory bench data, not human patient data. Therefore, questions of country of origin or retrospective/prospective do not apply in the context of human data studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable as this document solely describes bench testing of a physical device. There is no concept of "ground truth" derived from expert interpretation in this context, nor human subject data requiring expert review.

4. Adjudication method for the test set:

• Not applicable, as there are no human interpretations or judgments to adjudicate in bench testing.

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/software device, nor is it a diagnostic device that would involve human "readers" interpreting images.

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 (expert consensus, pathology, outcomes data, etc.):

• Not applicable. For bench testing of a physical device, "ground truth" refers to the engineering specifications and measurable physical properties of the device, assessed through specific testing methodologies (e.g., measuring dimensions, tensile strength, successful stone capture in a simulated environment). This is not equivalent to clinical ground truth from patient data.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

• Not applicable. There is no "training set" or "ground truth" in the AI/ML sense.

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