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The KD sphincterotomes and the predicated devices are all designed specifically to perform endoscopic sphincterotomy of the papilla of Vater

The KD sphincterotomes and the predicated devices are all designed specifically to perform endoscopic sphincterotomy of the papilla of Vater. The KD sphincterotomes consist of three primary parts: a proximal end control handle, a flexible catheter-like tube, and a distal end knife wire. The catheter shaft contains a thin steel wire that exits the catheter shaft for a short length and then re-enters the shaft. The exposed wire is referred to as the knife wire. The knife wire may be either tensioned or pushed to position the wire for cutting. This is accomplished by maneuvering the control handle slider accordingly. The detachable control handle contains the electrical connections which permit the knife wire to be connected to an electrosurgical generator.

This document, "955247," is a 510(k) Summary for the Olympus KD Series of Sphincterotome, submitted on April 30, 1996. It describes a medical device, not an AI or algorithm-driven system. Therefore, most of the requested information about acceptance criteria, study design, ground truth, and training data, which are relevant to AI/ML device evaluations, are not applicable here.

Here's a breakdown based on the provided document:

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

   • Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria in the format typically seen for performance metrics of diagnostic or AI devices (e.g., sensitivity, specificity, accuracy thresholds). The primary "acceptance" for this type of device in a 510(k) summary is demonstrating substantial equivalence to predicate devices, focusing on shared technological characteristics and intended use.
   • Reported Device Performance: The document describes the device's design and intended function, which is "to perform endoscopic sphincterotomy of the papilla of Vater." It highlights its components (proximal end control handle, flexible catheter-like tube, distal end knife wire with exposed wire for cutting, electrical connections). The performance is implicitly tied to its ability to achieve this intended use safely and effectively, similar to its predicate devices. No specific quantitative performance data (e.g., success rate of cutting, complication rates) is provided in this summary.

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

   • Not Applicable. This 510(k) summary does not describe a clinical trial or performance study with a "test set" in the context of an AI/ML device. The assessment is based on substantial equivalence to existing predicate devices.

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. As this is not an AI/ML device requiring ground truth establishment, this information is not relevant or provided.

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

   • Not Applicable. No test set or adjudication method is described.

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-assisted device. No MRMC study is mentioned.

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

   • Not Applicable. This is a medical instrument (sphincterotome), not an algorithm.

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

   • Not Applicable. Ground truth, in the context of AI/ML, is not relevant for this device. The "truth" for this device relates to its mechanical and functional characteristics meeting design specifications and its safety and effectiveness being equivalent to existing, legally marketed devices.

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. As there is no training set, this question does not apply.

In summary: The provided document is a 510(k) summary for a conventional medical device (sphincterotome) seeking clearance based on substantial equivalence. It predates the widespread regulatory framework for AI/ML devices, and thus the questions posed are not applicable to the content of this specific submission. The "study" alluded to in the prompt would typically be a demonstration of substantial equivalence through comparison of technical characteristics, performance data (if available and relevant to equivalence), and intended use with predicate devices, rather than a clinical trial with a "test set" or "ground truth" as these terms are used for AI/ML evaluation.

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