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SPOT PRO is a software application for Brachytherapy Treatment Planning, for the treatment of cancer, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources.

SPOT PRO is a "real time" treatment planning system for brachytherapy especially meant for treatment of cancer in the prostate. Direct 3D Ultrasound imaging of the treatment gives the physician the possibility to update the planning of the radioactive seeds implant in the prostate of the patient. The software program provides the physician wih anatomical and dosimetric information, to determine the positioning and loading of the radioactive sources, prior to insertion. The software program provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution, i.e. dose volume histograms, dose verification points and dose profiles. The software program also provides the treatment time and dose distribution for the specified loading. From this the information the patient can be treated with radioactive sources. Modifications to SPOT previously cleared K992303, have been made to add functionality for: . Post Planning functionality . Auto activation dwell positions . Auto contouring . Usage of CT / MR images acquired by Dicom 3 Import/Export . The Post Planning functionality has been derived from Plato BPS K983343. The Dicom 3 Import/Export has been derived from Plato External Beam K964206. The software runs on a Windows NT platform.

The provided text describes a Special 510(k) for the Nucletron SPOT PRO device, a "real-time" treatment planning system for brachytherapy. However, the document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement in a study.

The document primarily focuses on:

• Identification of the device: Nucletron SPOT PRO, a radiation therapy planning system.
• Purpose: For brachytherapy treatment planning, especially for prostate cancer, assisting physicians in determining the positioning and loading of radioactive sources.
• Modifications: Post Planning functionality, Auto activation dwell positions, Auto contouring, and DICOM 3 Import/Export capabilities.
• Intended Use: Same as the predicate device (SPOT, K992303).
• Substantial Equivalence: To the predicate device and other Nucletron software (Plato BPS K983343 and Plato External Beam K964206).
• Regulatory information: Classification, product codes, and the FDA's clearance letter.

Therefore, I cannot provide the requested information in the table or answer the specific questions about acceptance criteria and study details because this information is not present in the provided text. The document is a regulatory submission for substantial equivalence rather than a detailed performance study report.

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