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The New Device and the ENDOPATH* Cholangiography Clamp Predicate Device have identical indications for use. The two devices, in fact, are the same instrument. The New Device and the ENDOPATH* Cholangiography Clamp are designed to grasp and introduce contrast medium into the gallbladder for evaluation of stones, blockage and/or other abnormalities. Both of these devices are intended for use in either minimally invasive or open surgical procedures. The Pre-View Cholangiography Clamp is intended to provide a method of laparoscopic cholangiography.

The PRE-VIEW* Cholangiography Clamp just like the ENDOPATH* Cholangiography Clamp consists of a 5mm clamp with a side channel for the introduction of a catheter. It is a hand held manual instrument designed for grasping and introducing contrast medium for cholangiography.

The provided text describes a 510(k) premarket notification for a medical device called the PRE-VIEW* Cholangiography Clamp. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data as would be required for a new device type.

Therefore, the information typically requested regarding acceptance criteria and detailed study design to prove performance is largely not applicable to this document. The core of this submission is to show that the new device is essentially the same as a previously cleared device.

However, I can extract the relevant information showing how "substantial equivalence" was established, which serves as the "study" in this context.

Here's a breakdown based on the provided text, acknowledging the limitations for a 510(k) submission:

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are effectively that the new device (PRE-VIEW* Cholangiography Clamp) performs equivalently to the predicate device (ENDOPATH* Cholangiography Clamp K 942450) across key characteristics.

Study Information (Based on 510(k) Substantial Equivalence Process)

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

   • Test Set Sample Size: Not applicable. No "test set" in the traditional sense of evaluating performance with patient data was described. The submission focuses on comparing the new device's design, indications, and technological characteristics to the predicate.
   • Data Provenance: The 'data' is a comparison of product specifications and intended use of the new device against the predicate device. This is internal information from the manufacturer (Nashville Surgical Instruments) and publicly available information about the predicate device (ENDOPATH* Cholangiography Clamp K 942450). It is retrospective in the sense that the predicate device was already marketed.

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

   • Not applicable. "Ground truth" in this context is the established characteristics and intended use of the predicate device. This is determined by the predicate device's existing 510(k) clearance and regulatory classification, not by experts establishing a new ground truth for a test set.

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

   • Not applicable. There was no "test set" requiring adjudication by multiple readers or judges for performance evaluation. The "adjudication" is the FDA's regulatory review of the substantial equivalence claim.

4. 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 device is a manual surgical instrument, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or is relevant.

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

   • Not applicable. This is a manual surgical instrument, not an algorithm.

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

   • The "ground truth," in the context of this 510(k), is the established regulatory profile (indications for use, technological characteristics, device characteristics, safety, and effectiveness) of the predicate device, the ENDOPATH* Cholangiography Clamp (K 942450). This is based on its prior clearance by the FDA.

7. The sample size for the training set:

   • Not applicable. There is no training set for an algorithm as this is a physical medical device.

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

   • Not applicable for the reasons stated above.

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