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Nucletron Implant Guidance System Applicator Set is intended for interstitial brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR. 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 Implant Guidance System as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, mHDR, and is intended for interstitial brachytherapy procedures. The Nucletron Implant Guidance System Applicator Set consists of an insertion needle with a plastic sheath, which is inserted through the skin surface into the target volume. The insertion needle is then removed and a closed end plastic catheter is placed into the sheath. A marker on the side of the insertion obturator insures the proper depth of catheter placement. Once the catheter is in place the sheath is removed and a button is placed over the plastic catheter and slid into contact with the skin surface. The catheter is then cut level with the button and attached. A closed end treatment needle is then inserted into the catheter, once in position a metal needle stopper is slid over the needle to the button surface and locked. Radiographic images, planar films or transverse slices, i.e. CT. MR is 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 treatment needle is then attached to the Nucletron remote afterloading equipment (treatment head), mHDR, by the Nucletron transfer tubes. The transfer tubes lock onto the open end of the treatment needles 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 session is complete, the treatment needles are detached from the transfer tube and remote afterioading equipment. The treatment needles are then removed from the patient. When the course of treatment is completed the catheters and buttons are 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 describes a Special 510(k) submission for the Nucletron Implant Guidance System Applicator Set, which is intended for interstitial brachytherapy procedures. However, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a regulatory submission for premarket notification (510(k)) to the FDA, demonstrating substantial equivalence to previously marketed predicate devices. It focuses on:

• Device Description: What the device is and how it works.
• Intended Use: The purpose of the device.
• Technological Considerations: How it compares to predicate devices.
• Regulatory Classification: Its classification under FDA regulations.
• Substantial Equivalence Determination: The FDA's letter confirming substantial equivalence.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and a study proving their fulfillment. The information requested, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth definitions, would typically be found in a performance study report, which is not present in this regulatory submission.

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