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This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.

The Fusion® OMNI Sphincterotome (subject device) is a sterile, single use device compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing high- frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation.

The provided text describes a 510(k) premarket notification for a medical device (Fusion® OMNI™ Sphincterotome), not an AI/ML-based medical device. Therefore, the information required to answer the questions regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), and ground truth establishment for AI/ML performance is not present in the provided document.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Identical Intended Use: The Fusion® OMNI™ Sphincterotome has the same intended use as the predicate device (Wilson-Cook OMNI™ Sphincterotome).
• Minor Technological Differences: These differences (e.g., catheter diameters, wire guide port, slightly decreased voltage) are deemed not to raise new questions of safety and effectiveness.
• Performance Data: This section details non-clinical bench testing, sterilization, shelf life, biocompatibility, and electrical safety/EMC testing, all of which are standard for traditional medical devices to ensure they perform as intended and safely.

There is no mention of an algorithm or AI/ML components, nor any studies that would involve human readers, ground truth established by experts for image interpretation, or training/test sets as would be required for such devices.

Therefore, I cannot provide the requested table or answer the specific questions about AI/ML device performance and validation based on the provided text.

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cannulation of the ductal system and sphincterotomy.

The proposed OMNI™ Sphincterotome is a triple-lumen sphincterotome. It is capable of accommodating wire guides from .018" to .035" in diameter while allowing simultaneous injection of contrast media through separate lumens. The subject sphincterotome also incorporates DomeTip™ technology and a breakthrough catheter feature.

The provided text is a 510(k) summary for the Wilson-Cook OMNI™ Sphincterotome. It states that the device is substantially equivalent to existing predicate devices based on performance characteristics and biocompatibility. However, it does not contain the detailed information requested regarding specific acceptance criteria, a study proving those criteria were met, sample sizes, ground truth establishment, or clinical performance metrics such as those typically found in a multi-reader multi-case study.

The document primarily focuses on regulatory approval (510(k) clearance) based on substantial equivalence to a predicate device, rather than providing a detailed performance study report.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

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

• Cannot be provided. The document states, "We believe the proposed device to be substantially equivalent to the named predicate in terms of performance characteristics tested and biocompatibility." It does not list specific acceptance criteria or their corresponding performance results.

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

• Cannot be provided. The document does not mention any specific test set, its sample size, or data provenance.

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)

• Cannot be provided. No information about experts or ground truth for a test set is present.

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

• Cannot be provided. No information about adjudication methods is present.

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

• Cannot be provided. The device is a medical instrument (sphincterotome), not an AI-powered diagnostic tool. Therefore, an MRMC study with AI assistance is not applicable to this type of device and is not mentioned.

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

• Cannot be provided. This question is not applicable as the device is a physical medical instrument, not an algorithm.

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

• Cannot be provided. No information about ground truth is present.

8. The sample size for the training set

• Cannot be provided. No information about a training set is present.

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

• Cannot be provided. No information about a training set or its ground truth establishment is present.

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