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Brachytherapy planning, utilizing a 3D ultrasound imaging cube, with Sonoaraphic Planning of Oncology Treatments (SPOT) is intended for use with brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal, involving manual or remote afterloading radioactive sources. The software program provides the physician with anatomical and dosimetric information to determine the positioning and loading of the radioactive sources prior to insertion. The software also provides the treatment time and dose distribution for the specified loading. From this information the patient can be treated with radioactive sources.

Sonographic Planning of Oncology Treatments (SPOT) as described in this submission is a software package which utilizes the acquisition of 2D ultrasound images and 3D reconstruction of the ultrasound images for treatment planning of brachytherapy procedures. This software runs on a Windows NT workstation.

Nucletron Sonographic Planning of Oncology Treatments (SPOT) software initially acquires 2D ultrasound images and generates 3D ultrasound image processing for definition of the treatment volume. These images are utilized for reconstructing the target volume of the brachytherapy implant, needles placement, defining the location of the radioactive sources within the implant, identifying a reference point, i.e. dose points. anatomical points. Once the treatment volume is identified and the implant is reconstructed the prescription dose is defined and the software program calculates treatment data, including dose distributions and treatment/implantation time.

The brachytherapy treatment planning session allows the physician to evaluate the implant prior to insertion of the radioactive sources in order to determine the most optimal dose distribution within the treatment volume. Once the physician approves the treatment plan the implant is loaded with radioactive sources manually or via the Nucletron remote afterloading equipment. The Sonographic Planning of Oncology Treatments (SPOT) software can export the treatment data to the Nucletron remote afterloading system and the PLATO Brachytherapy Planning System via a network. The Sonographic Planning of Oncology Treatments (SPOT) software does not control the treatment unit it strictly exports treatment times and related information. The Nucletron remote afterloading system and the clinical staff verify this data input prior to treatment.

Nucletron' Sonographic Planning of Oncology Treatments (SPOT) software includes remote afterloading radioactive source brachytherapy treatment planning and manual loaded radioactive source brachytherapy treatment planning. The 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, dose profiles, etc.

The provided document, a 510(k) summary for the Nucletron Sonographic Planning of Oncology Treatments (SPOT) device, does not contain the information requested regarding acceptance criteria and a study proving those criteria are met.

The document primarily focuses on establishing substantial equivalence to predicate devices, describing the device, its intended use, and technological considerations. It is a regulatory submission for premarket notification, not a report detailing performance studies against specific acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies based on the provided text. The document states:

• d. Description: "Sonographic Planning of Oncology Treatments (SPOT) as described in this submission is a software package which utilizes the acquisition of 2D ultrasound images and 3D reconstruction of the ultrasound images for treatment planning of brachytherapy procedures."
• f. Summary of technological considerations: "The Sonographic Planning of Oncology Treatments (SPOT) software is substantially equivalent to the predicate devices. It combines the functionality of the defined predicate devices into one user interface for brachytherapy treatment planning."

These statements indicate a descriptive explanation and a claim of substantial equivalence, but they do not outline performance metrics or studies to validate them against acceptance criteria.

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