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The Valencia Skin Applicator Set is intended for surface Brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR.

The Valencia Skin Applicator Set as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, microSelectron and is intended for surface Brachytherapy procedures. The Valencia Skin Applicator is placed over the treatment area. The applicator is then attached to the afterloader (treatment head), using transfer tubes. 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 afterloader and the clinical staff verify that the applicator is properly attached prior to the 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. After the treatment the applicator is disconnected from the attached transfer tubes, and removed from the patient. The device is the same as the legally marketed predicate device cited. The only change is that the device is equipped with a fixed flattening filter that provides a flat homogeneous isodose pattern. The Valencia Skin Applicator Set is used as an accessory to the Nucletron microSelectron.

The provided text is a 510(k) summary for the Valencia Skin Applicator Set. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria or a study proving device performance against such criteria.

The document focuses on:

• Device Description: The Valencia Skin Applicator Set is an accessory to Nucletron remote afterloading equipment (microSelectron) for surface brachytherapy procedures. It guides a radioactive source to deliver a prescribed dose of radiation. The only change from the predicate device is a fixed flattening filter for a flat, homogeneous isodose pattern.
• Intended Use: For surface brachytherapy procedures involving Nucletron remote afterloading equipment (mHDR).
• Substantial Equivalence: It is substantially equivalent to the Nucletron BV Leipzig Applicator Set (K953946).

Since the document provided does not include the requested information about acceptance criteria and a study to prove device performance, I cannot fill out the requested table or answer the specific questions about sample size, ground truth, expert qualifications, or MRMC studies.

Therefore, the answer is that this information is not available in the provided text.

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