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To be used during diagnostic laparoscopy, minilaparotomy, fertility examinations, and salpingoplasty.

Uterine Manipulator / Injector

The provided text is a 510(k) clearance letter from the FDA for a Uterine Manipulator/Injector, dated February 2, 1998. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria as typically found in submissions for AI/ML-based medical devices.

The document pertains to a physical medical device (Uterine Manipulator/Injector) cleared through the 510(k) pathway, indicating substantial equivalence to a predicate device. This pathway generally relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials with acceptance criteria thresholds for performance metrics like sensitivity, specificity, or AUC as seen in AI/ML device submissions.

Therefore, I cannot provide the requested information because it is not present in the provided text. The questions posed in your prompt (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are relevant to the evaluation of AI/ML-based devices and are not applicable to the traditional medical device clearance described in this document.

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