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Nucletron Frieburg Flap Applicator Set is intended for skin surface or intraoperative brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR. The applicator provides 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 Freiburg Flap Applicator as described in this submission is designed as an accessory to the Nucletron remote aftertoading equipment: mHDR, mHDR-Classic and mPDR, and is intended for skin surface and intraoperative brachytherapy procedures.

The Nucletron Freiburg Flap Applicator Set is placed on the skin or organ surface 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-Classic and mPDR, by the Nucletron transfer tubes. The transfer tubes lock onto the open end of the treatment catheters and the remote afterloading equipment (treatment head) prior to treatment. When the applicator is 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 the prescribed dose of radiation. When the treatment is complete, the treatment catheters are 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.

I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study proving the device meets them. The document is a 510(k) summary for the Nucletron Freiburg Flap Applicator Set, which describes the device, its intended use, and its substantial equivalence to a predicate device. It also includes the FDA's clearance letter. However, it does not contain details about specific performance metrics, clinical studies, or data analysis as requested in your prompt.

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