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3D Bolus and 3D Brachy applications are indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during external beam (photon or electron) radiation therapy, and surface brachytherapy. Users may choose to send the Stereolithography (STL) files to Adaptiiv Medical Technologies Inc. to 3D print the external beam radiation therapy accessories to the specification of the prescribing radiation therapy professional or 3D print either external beam or surface brachytherapy accessories in-house. If 3D printing is performed by Adaptiiv Medical Technologies Inc., 3D printed accessories will be sent to the requesting care center for the final quality control and acceptance by the trained radiation therapy personnel. The use of 3D Bolus and 3D Brachy applications as well as the 3D printed radiation therapy accessories is by prescription only.

Adaptiv Medical Technologies Inc. solution is software as a medical device that consist of two (2) separate desktop applications:

• 3D Bolus Software Application, which includes the Simple Bolus and Modulated Electron Bolus modules; a.
• 3D Brachy Software Application, which includes the Surface Brachytherapy module. b.

The 3D Bolus and 3D Brachy software applications enable trained radiation therapy personnel to use DICOM and DICOM RT files from the radiation therapy treatment planning system (TPS) as inputs to produce Stereolithography (STL) files are compatible with the third-party 3D printing of the customized, patient-matched accessories for external beam radiation therapy, and or surface brachytherapy applicators in-house or through Adaptiv's OnDemand function. Accessories generated by the Adaptiv's software must be verified by the trained radiation therapy professionals on their TPS for correctness prior to print initiation or accessory order through Adaptiiv OnDemand.

Adaptiv's 3D printed patient-matched radiation therapy accessory that expands the application of external-beam radiation therapy, allowing to overcome the skin-sparing effects inherent to high energy photons and electrons. If 3D printing is to be performed by Adaptiv Medical Technologies Inc., desired external beam radiation therapy accessories will be 3D printed using the HP Jet Fusion 5200 Series 3D Printing Solution. Adaptiiv Medical Technologies Inc. has validated the Ultrasint® Thermoplastic polyurethane (TPU01) powder for use in 3D printing of radiation therapy accessories.

The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets those criteria. It is a 510(k) premarket notification summary for the Adaptiiv Medical Technologies Inc. 3D Bolus Software Application, 3D Brachy Software Application, and Patient-Matched 3D Printed Radiation Therapy Accessory.

The document mentions that "Verification and Validation studies were performed to show substantial equivalence... to ensure that 3D Bolus and 3D Brachy software applications meet the established product specifications and can be used safely and effectively." It also states, "Spatial fidelity, dimensional consistency, and 3D printed material unifornity were assessed to ensure compliance with the required product specifications."

However, it does not provide:

1. A table of specific acceptance criteria and reported device performance.
2. Sample sizes for test or training sets, data provenance, ground truth establishment methods, or details on expert involvement (number, qualifications, adjudication).
3. Information on MRMC studies or a standalone performance study.

Without this specific information from the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and study details. The document focuses on regulatory compliance, description of the device and its indications for use, and a comparison to a predicate device for substantial equivalence. It summarizes the types of non-clinical testing performed (unit testing, integration testing, system testing) but does not present the results or the detailed methodology in the format requested.

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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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