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The Universal Endometrial Applicator Set is indicated for use for treating cancer of the vagina, cervix, endometrium and uterus using HDR or PDR brachytherapy.

The Universal Endometrial Applicator Set (GM11009840) consists of key device components and accessories made of titanium tandems and PEEK vaginal cylinder to allow for adaptation to individual anatomical situations for intracavitary brachytherapy. The Applicator is inserted into the patient and connected to an afterloader. The applicator acts to guide the radioactive source from the afterloader to the correct location or locations for treatment. This combination places the remote-controlled radioisotope treatment source (brachytherapy source) nearby the target tissue. The key device components include: Intrauterine tandems (left angle, straight and right angle) Endometrial applicator clamping unit with grub screws & allen wrench Vaginal cylinder with lever handle Sterilization box Cleaning caps

This document, a 510(k) Premarket Notification from the FDA, describes the Universal Endometrial Applicator Set. However, it does not contain the type of acceptance criteria or study details typically associated with AI/ML-powered medical devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing for material changes, biocompatibility, cleaning, sterilization, and compliance with various standards.

Therefore, I cannot provide the requested information in the format given because the document is for a physical medical device (an applicator set) and not for an AI/ML device that would have performance metrics like sensitivity, specificity, or AUC, nor study details like sample sizes for test/training sets, expert ground truth establishment, or MRMC studies.

The document explicitly states: "No clinical tests have been included in this pre-market submission." This further confirms that the type of performance data and study details requested are not present in this submission.

If the request was based on a misunderstanding of the document's content, please clarify if you have a document pertaining to an AI/ML medical device.

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