(73 days)
The Wilson-Cook Cystotome is intended for use as an electrosurgical accessory to electrosurgically cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst, when it is visibly bulging into the gastrointestinal tract. It is supplied sterile and is intended for single use.
The Wilson-Cook Cystotome consists of an inner wire with needle knife tip, a 5 Fr inner sheath, and a 10 Fr outer sheath equipped with a diathermic ring at its distal tip. The proximal end of the device will include a handle with connectors for active cords and a fitting to provide for injection of contrast fluid.
The provided text describes a 510(k) submission for the Wilson-Cook Cystotome, a medical device. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device already legally marketed, rather than proving effectiveness through a study against acceptance criteria. Therefore, the information requested in the prompt, which pertains to AI/algorithm performance and detailed study methodologies with specific acceptance criteria, is not present in the provided document.
Here's why and what can be inferred:
- Device Type: The Wilson-Cook Cystotome is an "Endoscopic electrosurgery device" for surgical procedures, not an AI or diagnostic imaging device.
- Submission Type: A "510(k) Premarket Notification" is for devices that are "substantially equivalent" to legally marketed predicate devices. This means the primary evidence required is a comparison of the new device's technological characteristics and intended use to an existing device, rather than extensive clinical trials with pre-defined performance metrics like sensitivity, specificity, etc., against a gold standard.
- "Discussion of Tests and Test Results": The document briefly mentions "electrical testing, simulated use testing, and clinical testing." However, it does not elaborate on the specific acceptance criteria for these tests, the methodologies, sample sizes, or a detailed report of the results that would allow for filling the requested table regarding device performance against acceptance criteria. The "clinical testing" mentioned is likely to demonstrate safety and basic performance in a clinical setting, not a comparative effectiveness study in the sense of AI.
- Lack of AI-specific elements: The prompt asks about "AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the loop performance)," "training set," and "ground truth for the training set." These are all concepts related to AI or machine learning device evaluation, which are completely irrelevant to a surgical instrument like the Wilson-Cook Cystotome.
Therefore, I cannot populate the table or answer most of the questions as the provided document does not contain the required information.
If this were an AI/ML device submission, the acceptance criteria would typically be detailed quantitative performance metrics (e.g., sensitivity, specificity, AUC) and the study would describe a rigorous clinical or retrospective evaluation to meet those metrics. The provided document is for a traditional medical device and follows a different regulatory pathway.
§ 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).