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The Nathanson Transcystic Bile Duct Stone Exploration Pack is intended for extraction of bile duct stones via laparoscopic transcystic approach.

The Nathanson Transcystic Bile Duct Stone Exploration Pack is a pre-assembled device comprising of a cholangiography catheter, a flatwire stone basket, "Y" Tuohy-Borst adapter, and a connecting tube assembly with a stopcock. The device is used in a healthcare facility/hospital environment during common bile duct exploration procedures. The subject device requires a transcystic surgical approach by a clinician for the removal of bile duct stones. When complete removal of common bile duct stones cannot be achieved, alternative approaches such as endoscopic retrograde cholangiography with sphincterotomy (ERCP) may be considered. The subject device is provided sterile and for single-use only.

The provided text describes a 510(k) premarket notification for a medical device called the "Nathanson Transcystic Bile Duct Stone Exploration Pack". The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a comparative effectiveness study involving AI or human readers.

Therefore, the requested information about acceptance criteria, study design for proving device performance (especially for AI/human reader studies), sample sizes for test/training sets, expert involvement, and ground truth establishment, cannot be found or inferred from the provided document as it relates to a traditional premarket notification for a mechanical medical device, not an AI/ML software.

However, I can extract the acceptance criteria and performance as presented for the mechanical and biocompatibility testing of the device, which is relevant to a non-AI medical device.

Here's the information that can be extracted relevant to the provided text:

Acceptance Criteria and Reported Device Performance (for a Traditional Medical Device)

The document outlines acceptance criteria and corresponding test results for various components and aspects of the Nathanson Transcystic Bile Duct Stone Exploration Pack.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify the exact sample sizes for the physical and biocompatibility tests. It refers to "test articles" but does not quantify them.
• The only reference to a "study" is a retrospective clinical study from 2007 (Taylor et al, 2007).
  • Sample Size: 160 consecutive patients.
  • Data Provenance: Not explicitly stated (e.g., country of origin), only that it's a "retrospective study."

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 and not provided for this type of device submission. The test results are based on engineering specifications and laboratory testing, not expert interpretation of medical images or data.
• The clinical study mentioned is a retrospective review of patient outcomes, not an expert panel establishing ground truth for a new device's performance.

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

• This information is not applicable and not provided. Adjudication methods are typically used in clinical trials or studies where human assessment or interpretation is involved in determining an outcome, which is not the primary focus of this 510(k) submission's testing section.

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 comparative effectiveness study was not done. This is a mechanical medical device, not an AI-powered diagnostic tool. The document focuses on physical and chemical properties and a retrospective clinical review of outcomes.

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

• No, this is not applicable. There is no algorithm or AI component in this device.

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

• For the physical tests: The "ground truth" is defined by engineering specifications and pre-determined acceptance criteria based on established standards (e.g., ISO 10993-1, force measurements in Newtons, length in mm).
• For the clinical study mentioned: The "ground truth" is patient outcomes data (e.g., successful common bile duct exploration, need for additional intervention, major morbidity, biliary leak, stricture).

8. The sample size for the training set:

• Not applicable. This document describes a mechanical medical device, not an AI/ML algorithm requiring training data.

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

• Not applicable. As above, no training set for an AI/ML algorithm is involved.

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