(7 days)
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.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).