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Nucletron Intracavitary Applicator Sets: Vacinal CT/MR. Standard CT/MR. Ring CT/MR and Fletcher-Williamson are intended for use with the Nucletron remote afterloading equipment, mHDR, mHDR-Classic and mPDR, for intracavitary brachytherapy. The applicators provide a means of delivering the prescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids.

The Nucletron Intracavitary Applicator Sets: Vaginal CT/MR, Standard CT/MR, Ring CT/MR and Fletcher-Williamson, as described in this submission are designed as accessories to the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR, for intracavitary brachytherapy procedures. Standard CT/MR, Ring CT/MR and Fletcher-Williamson Applicator Sets can be used for gynecological treatment of the cervix and endometrium. The Vaginal CT/MR can be used for treatment of the vagina, rectum and endometrium.

The Nucletron Intracavitary Applicator Sets are inserted into the body and immobilized. Radiographic images, planar films or transverse slices, i.e. CT, MR are obtained to determine the precise location of the applicator within the body. This information is then used for brachytherapy treatment planning purposes. When the treatment planning is completed the applicator is then attached to the Nucletron remote afterloading equipment (treatment head): mHDR, mHDR-Classic and mPDR, by the Nucletron transfer tubes. These transfer tubes lock into the open end of the applicator and the remote afterloading equipment (treatment head) prior to treatment. When the applicator is properly attached, a check cable run is performed to ensure that the applicator is properly attached and that there are no obstructions which will interrupt treatment. After the check cable run, the radioactive source will step through the applicator to deliver that prescribed dose of radiation. When the treatment is complete, the applicator is detached from the transfer tube and remote afterloading equipment. The applicator is then removed from the patient. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids. The applicator does not control the treatment unit; it strictly provides a treatment path for the radioactive source. The Nucletron remote afterloading system and the clinical staff verify that the applicator is properly attached prior to treatment

The provided text is a Premarket Notification (510(k) submission) for Nucletron Intracavitary Applicator Sets. This document is a regulatory submission for medical devices and does not contain information regarding studies that establish acceptance criteria or device performance metrics for diagnostic algorithms or AI models.

The document states that the Nucletron Intracavitary Applicator Sets are substantially equivalent to legally marketed predicate devices (K953946) and combine their functionality, components, and design while incorporating a new material. This substantial equivalence is the basis for their clearance, rather than extensive performance studies often associated with novel AI devices.

Therefore, I cannot provide the requested information from the given text as it pertains to a different type of device and regulatory pathway. There is no information about acceptance criteria, device performance, sample sizes, ground truth establishment, or human-in-the-loop studies.

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