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3D Bolus Software is indicated for, and intended for use as, an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy.

The 3D Bolus Software is a device consisting of software that is used in conjunction with a radiation therapy treatment planning system (TPS) to produce a software file that can be used with a 3D printer to produce a customized, patient-specific bolus for electron or photon external beam radiation therapy or a customized, patient-specific surface brachytherapy mold. A radiation therapy bolus is used when treating uneven surface areas of a patient, such as at the nose or ears, to make up for missing tissue, or to provide build-up of dose to the skin surface. The use of a 3D printed bolus in postmastectomy radiation therapy has been proven to not only improve fit of the bolus, but also reduces patient setup time by approximately 30% compared with standard vinyl gel sheet bolus, according to an intra-patient study comparing both methods. Additionally, the 3D Bolus Software designed bolus can modulate electron beam radiation therapy to produce a conformal high dose region around the tumor.

Files for three types of structures can be generated by the 3D Bolus Software and checked by the user on their TPS for correctness. When accepted by the user, the 3D Bolus Software will create a Stereolithography (STL) file for the user to print on a thirdparty 3D printer located within the facility.

The provided text is a 510(k) summary for the "3D Bolus Software". It describes the device, its intended use, and compares it to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC study results, or standalone algorithm performance metrics).

The document states:

• "Verification and Validation were performed for all features. System requirements can be traced to the test outcomes."
• "The outcome was that the product conformed to requirements, the defined user needs and intended uses and that there were no remaining software anomalies which affect safety or effectiveness."
• "The nonclinical testing performed includes essential performance testing, functional performance characteristics testing and software verification and validation testing. All tests confirmed that the 3D Bolus System performs as intended and is substantially equivalent to the predicate."

This language indicates that testing was conducted to ensure the software functions as designed and meets its requirements. However, it lacks the quantifiable details necessary to fill out the requested table and answer the specific study-related questions.

Therefore, I cannot provide a detailed answer to your request based solely on the provided text. The document confirms that testing occurred and was successful in demonstrating substantial equivalence, but it does not disclose the specific criteria or methods used.

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