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The use of sealed Radioisotopes to treat tumors within the body has been documented and published since the turn of the century. Modern era Radiation Therapy has developed delivery systems using isotopes of Cesium, Iridium, Iodine, and Gold to name a few examples. Many tumors now are treated by internal exposure to radiation emitted from sealed radioactive sources. Two common modalities for this are Low Dose Rate and High Dose Rate remote afterloading (Brachytherapy). One common application of Brachytherapy is in the treatment of cancer of the cervix. This applicator is designed as an accessory to the Varisource System (Varian Associates K952913) and the Gammamed System (K891131/A) which uses a single radioactive source of Iridium-192 to treat cancer in a wide range of body sites. The HDR Tandem/Ring Applicator with Rectal Retractor is placed in the vicinity of the vagina just as described for the predicate device (Nucletron Ring Applicator, K953946) and with a rectal retractor and varying intrauterine tube length diameters, clinical needs can be best optimized along with minimization of dose to the rectum.

The Mick Radio-Nuclear Instruments, Inc.. HDR Tandem/Ring Applicator with Rectal Retractor is intended for use in Brachytherapy. The delivery of intra-cavitary radiation therapy requires not only proper visualization and localization of the applicator within the treatment volume, but precise dosimetry and a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear HDR Tandem/Ring Applicator with Rectal Retractor meets these requirements.

This document is a 510(k) premarket notification for a medical device, the "HDR Tandem/Ring Applicator with Rectal Retractor," from Mick Radio-Nuclear Instruments, Inc. It addresses the device's substantial equivalence to predicate devices, not an AI/ML device or a study proving acceptance criteria in the typical sense of diagnostic accuracy or performance metrics.

Therefore, the requested information for acceptance criteria and a study proving the device meets them, including sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this submission.

This 510(k) summary focuses on demonstrating that the new device is as safe and effective as previously cleared (predicate) devices, primarily through comparison of design, materials, intended use, and performance characteristics. It does not involve a clinical study with performance metrics as one would find for an AI/ML diagnostic or predictive device. The "performance characteristics" mentioned are in the context of the device's physical and functional attributes for brachytherapy application, not in terms of AI model performance.

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