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The MicroSelectron V3 is intended to enable an operator to apply, by remote control, a radionuclide source into the body (including Interstitial, Intracavitary, Intraluminal, Bronchial, Endovascular and Intra-operative) or to the surface of the body for radiation therapy.

The MicroSelectron V3 delivers a radiation dose distribution conforming to treatment data, which is either, manually entered at the workstation or imported from a treatment planning system. For a treatment, a source and applicator are minimally required. Treatment can be administered via up to 30 applicators connected to 30 channels in the treatment unit. The dose distributions are achieved by sequentially letting the source dwell in required positions within the applicators. The required dose distribution can be delivered according to two principles: The "high dose rate brachytherapy" principle (HDR) and The "pulsed dose rate brachytherapy" principle (PDR). The MicroSelectron V3 consists of the following main components: Treatment Unit (TU), Treatment Control Panel (TCP), Treatment Control Station (TCS), Remote Control Unit (RCU) (optional for HDR), and Nurse Station Display (Optional).

The provided text is a 510(k) Summary for the MicroSelectron V3, a remote-controlled radionuclide applicator system. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation studies for AI/ML-enabled devices.

The MicroSelectron V3 is a hardware device for brachytherapy and not an AI/ML-enabled medical device. Therefore, the questions regarding acceptance criteria, performance metrics, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable in the context of this document.

This 510(k) submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (MicroSelectron PDR, K041933) based on technological considerations, intended use, and modifications to existing functionalities rather than on performance metrics derived from a study designed to meet specific acceptance criteria for diagnostic or predictive accuracy.

Therefore, I cannot extract the requested information from the provided text.

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