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The TRUCLEAR Tissue Removal Devices are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: Submucous myomas Endometrial polyps Retained products of conception

Smith & Nephew's TRUCLEAR ULTRA Mini Tissue Removal Device is a single use device that hysteroscopically removes intra-uterine tissue. The device consists of a stainless steel inner tube that rotates and reciprocates inside a stainless steel outer tube. The proximal ends of the tubes are enclosed within a plastic housing. The housing is engaged with the TRUCLEAR Handpiece which drives the inner tube of the device. The inner tube has a sharp cutting edge that resects tissue in the cutting window at the distal end of the outer tube. The resected tissue is simultaneously aspirated out of the uterine cavity using suction.

The provided text describes a 510(k) premarket notification for a medical device called the "TRUCLEAR ULTRA Mini Tissue Removal Device." This document focuses on demonstrating the substantial equivalence of the new device to a predicate device through various non-clinical bench tests. However, it does not include information about a study proving the device meets acceptance criteria related to human-in-the-loop performance, multi-reader multi-case studies, standalone algorithm performance, or the establishment of ground truth by multiple experts for an AI/algorithm-based device.

The listed tests (Shed Test, Cutting Performance Test, Resection Rate Test, Biocompatibility Testing, Shelf Life Testing) are all bench tests evaluating the physical and functional performance of the device itself (e.g., blade wear, cutting durability, tissue removal speed, material safety, and shelf life). They are not clinical studies involving human patients or complex image analysis that would require the establishment of ground truth by experts or evaluate human reader performance with or without AI assistance.

Therefore, I cannot provide the requested information for acceptance criteria and studies demonstrating performance in the context of human-in-the-loop or AI-assisted medical device performance, as the provided document pertains to a physical surgical device with mechanical and material performance testing.

To elaborate, the document indicates:

• Device Type: A hysteroscopic tissue removal device, which is a physical surgical instrument.
• Performance Tests: Focus on mechanical function (cutting, shedding, resection rate), material safety (biocompatibility), and stability (shelf life).
• Context: 510(k) submission for substantial equivalence to a predicate device, based on bench testing.

The information necessary to answer your specific questions (e.g., number of experts, adjudication methods, MRMC studies, standalone algorithm performance, ground truth for training/test sets) is entirely absent because the device and the nature of the submitted data do not involve AI, image analysis, or diagnostic interpretation that would necessitate such studies.

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The Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as:

Submucous myomas
Endometrial Polyps
Retained products of conception

The Myosure Hysteroscopic Tissue Removal System consists of the following procedural components which are identical to those found in the predicate TRUCLEAR Morcellator System:

• Tissue Removal Drive System
• Tissue Removal Device

The Myosure Hysteroscopic Tissue Removal System uses mechanical resection to remove endometrial polyps and submucous myomas hysteroscopically from the uterus. Mechanical resection allows the surgeon to have precise control of the locations and extent of tissue resected by drawing the targeted tissue into the cutting window under suction while the inner blade cuts the tissue. There have been no major changes in design or materials in the subject Myosure System or its associated tissue removal devices since their market clearance.

This document is a 510(k) Summary for the Myosure Hysteroscopic Tissue Removal System. It describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or software.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device for the purpose of market clearance for an electromechanical medical device, not on evaluating the performance of an AI system against specific metrics.

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