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The Kuske Breast Applicator Set has the same intended use as the legally marketed predicate device cited: Nucletron Kuske Breast Applicator Set is intended for use with Interstitial breast brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR, mHDR-Classic, mPDR and mLDR. 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 purpose of the Modification of the Device is to is to provide a tool for guiding the needles on a well determined position through the breast. The Kuske Breast Applicator Set is based on the microSelectron HDR V2 Breast Template for interstitial breast treatment. The template has been slightly modified in shape and hole alignment to accommodate dimensions of the breast. The main shape of the Kuske Breast Applicator is a bridge supporting 2 templates which will be positioned at both sides of the breast. Each template contains well dimensioned holes which quide the needles in a straight way through the breast. Coordinates for each hole provide position information. The needles are exchanged after placing the flexible implant catheters, which will be connected to the afterloader. The material for the Kuske Breast Applicator has been changed, to accommendate the use of CT/MR techniques. The Kuske Breast Applicator Set uses similar materials as the legally marketed predicate device cited (MicroSelectron HDR V2: CT/MR Ring Applicator). With respect to the the legally marketed predicate device cited (MicroSelectron HDR V2: Breast Template), the shape has been changed and the number of holes has been increased to accommendate better needle placement. The Kuske Breast Applicator Set is an accessory to the microSelectron-HDR (V2).

This document is a 510(k) summary for the Nucletron Kuske Breast Applicator Set, which is a physical medical device, not an AI/ML-driven software device. Therefore, the questions related to software performance, such as acceptance criteria for AI models, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies, are not applicable.

The document describes the device, its intended use, and its substantial equivalence to a legally marketed predicate device. The review focuses on material changes and design modifications from the predicate device.

Here's the relevant information that can be extracted from the provided text, demonstrating that it's a submission for a physical device:

1. Device Type: The document explicitly refers to the "Kuske Breast Applicator Set" as an "accessory to the microSelectron-HDR (V2)" and describes it as having "templates which will be positioned at both sides of the breast" with "dimensioned holes which quide the needles." This clearly indicates a physical device used in radiotherapy.
2. Technological Considerations: The "Summary of technological considerations" states that "The Kuske Breast Applicator Set is substantially equivalent to the cleared predicate device,microSelectron-HDR V2, 510(k)#: K953946." This is a common approach for physical device 510(k) submissions, focusing on comparing the new device to an existing one.
3. Material Change: "The material for the Kuske Breast Applicator has been changed, to accommendate the use of CT/MR techniques." This is a physical modification.
4. Shape and Hole Alignment: "With respect to the the legally marketed predicate device cited (MicroSelectron HDR V2: Breast Template), the shape has been changed and the number of holes has been increased to accommendate better needle placement." These are physical design changes.
5. Predicate Device: The predicate device is also a physical medical device: "microSelectron-HDR V2".
6. Regulation Number and Name: "Regulation Number: 21 CFR 892.5700," and "Regulation Name: Remote controlled radionuclide applicator set," both point to physical radiotherapy equipment.

Conclusion:

Since the provided text describes a physical medical device and not an AI/ML software, the requested information regarding AI/ML performance acceptance criteria, study details, and ground truth establishment is not applicable to this document. The approval (K022635) is for a physical medical accessory based on substantial equivalence to an existing physical device.

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