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The Medi-Globe Rota-Cut® Sphincterotome is intended for transendoscopic cannulation of the Biliary system and sphincterotomy of the Papilla of Vater an/or the Sphincter of Oddi.

The proposed Medi-Globe Rota-Cut® Sphincterotome is available in single, double or triple lumen models and allows incremental, rotational orientation of the distal catheter tip and cutting wire. Device models are compatible with either .021 or .035" guide wires and allow simultaneous injection of contrast medium during use.

This is a 510(k) premarket notification for a medical device, the Medi-Globe Rota-Cut® Sphincterotome. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with specific acceptance criteria and performance metrics for a novel technology. Therefore, the information requested in your prompt regarding acceptance criteria, performance data, sample sizes, ground truth, and expert involvement is largely not applicable in the context of this specific regulatory document.

Here's an explanation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. The 510(k) submission for the Medi-Globe Rota-Cut® Sphincterotome does not present specific quantitative acceptance criteria or detailed device performance metrics in the way a novel AI or diagnostic device would. Instead, it relies on demonstrating substantial equivalence to predicate devices.

The "Performance Data" section states: "Design verification tests have demonstrated that the proposed Rota-Cut® sphincterotomes meet the same performance standards and biocompatibility requirements and is as safe and effective as the currently cleared GIP/Medi-Globe device, (K943629/A)."

This implies that the acceptance criterion for the new device is to perform as well as or equivalently to the predicate device in terms of "performance standards and biocompatibility requirements" and be "as safe and effective." However, no explicit numerical criteria or specific performance values are listed in this document.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable. No specific "test set" in the context of clinical data for performance evaluation is described. The "design verification tests" are likely referring to bench testing, engineering validation, and biocompatibility testing as per standard medical device development. No human subject data (retrospective or prospective) is mentioned as being used to prove the device's performance against specific metrics through a test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not Applicable. Ground truth, in the sense of expert consensus on clinical findings, is not established for any test set because there is no clinical test set described in this document to evaluate the device's diagnostic or predictive performance.

4. Adjudication Method

Not Applicable. Since there is no test set with clinical findings requiring ground truth establishment, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a medical device for surgical intervention (sphincterotomy), not an imaging or diagnostic AI device. MRMC studies are typically used for assessing the impact of AI on human readers' diagnostic accuracy. This is not relevant to the Rota-Cut® Sphincterotome.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. The Medi-Globe Rota-Cut® Sphincterotome is a physical surgical instrument, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable.

7. The Type of Ground Truth Used

Not Applicable. As explained above, no clinical "ground truth" for diagnostic or predictive outcomes is mentioned because the performance evaluation is based on substantial equivalence to an existing device, focusing on "performance standards, biocompatibility requirements," and being "as safe and effective." The ground truth for these types of evaluations is often established through well-defined engineering specifications, material standards, and preclinical (e.g., animal or bench) testing protocols.

8. The Sample Size for the Training Set

Not Applicable. Since the device is a physical instrument and not an AI algorithm, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for an AI algorithm, this question is not applicable.

In summary, the provided document is a 510(k) summary for a substantial equivalence claim for a physical medical device. It focuses on comparing the new device's technological characteristics, intended use, and safety/effectiveness to previously cleared predicate devices. The detailed performance and clinical study information, including acceptance criteria, sample sizes, and ground truth methodologies, as typically found for novel AI/diagnostic devices, are not present in this type of regulatory submission and are not relevant to demonstrating substantial equivalence for a device like a sphincterotome. The "study" mentioned is "Design verification tests," which are engineering and biocompatibility tests intended to show equivalence to the predicate, not clinical trials with human subjects as implied by many of your questions.

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