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For uterine aspiration/uterine evacuation in obstetric and gynecological patients. Indications for use are rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy.

The Rigid Cannulae are injection molded plastic devices approximately 190mm in length, made from a styrenic copolymer manufactured in sizes 6mm. 7mm. 8mm. 9mm. 10mm, 11mm, and 12mm (outer diameter), straight and curved.

The provided text describes a 510(k) submission for "Rigid Uterine Cannulae." This type of device is a physical instrument, not an AI/ML powered medical device. Therefore, the questions related to AI/ML device performance (such as acceptance criteria for AI, sample sizes for test/training sets, experts for ground truth, or MRMC studies) are not applicable to this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through comparisons of design, materials, and bench testing for physical strength and vacuum performance.

The questions you've asked are relevant for AI/ML powered medical device submissions, which typically involve software that processes data (like medical images) to generate an output. This submission describes a physical medical tool.

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