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The primary purpose and intended use of this device is to improve the efficiency of designing patient specific radiation therapy beam-shaping block devices through the use of optical scanning technology. This device will serve as a direct replacement to the current processes for designing such radiotherapy devices in cases where a "clinical patient set up" is used (i.e. cases where the treatment field is determined by direct physician examination, not by internal imaging technology). This product is not intended to replace CT imaging or other internal imaging modalities and should be used only in cases where a qualified radiation oncologist has made appropriate determination of the acceptability of a "clinical patient set up" approach, independent of any information provided by this application. In other words, the role of this product is to simply ensure efficient and accurate ordering of a patient-specific beam-shaping block device from our company, in cases where a licensed radiation oncologist has predetermined that such a device and treatment approach is appropriate for the patient at hand. Thus this device's indications for use include patients with a variety of cancer and disease conditions, which will be treated under the direct supervision and guidance of a radiation oncologist that has prescribed a desired dose of radiation to be delivered to the patient.

This device is a software product with the primary purpose to improve the efficiency of designing patient specific radiotherapy treatment devices. It uses proven off-the-shelf optical scanning technology to replace portions of the current clinical treatment device design workflow to achieve this goal. Specifically, this device uses an off-the-shelf depth sensing scanner to accurately capture and construct a full color, 3D model of a patient's treatment area. This scanner captures dimensionally accurate depth information in realtime using a combination of a structured light field infrared projector and infrared camera, and is coupled with a color camera to provide precise, full color, 3D models of patients without exposing them to any harmful radiation. Our decimal3D software is an iPad application that guides users through the process of capturing a scan of a patient. It then provides tools that allow users to digitize the treatment area, which is pre-drawn on the patient's skin by the radiation oncologist, on the 3D model. Users also specify other device parameters, such as their treatment machine type, applicator size, and treatment direction, which allows the decimal3D software to complete the design of their treatment device. Finally, our software allows them to view and order the device for fabrication by our company. This process is directly analogous to the current digitization process in the existing clinical workflow except the predicate software device requires the user to use a clear plastic template placed in the head of the actual treatment delivery machine to project the device shape to the patient's skin surface using a light field. This acrylic template is then scanned using a flatbed document scanner and the shape is digitized in 2D using the predicate software.

The Astroid Planning App is an interactive end user application for proton treatment planning for the intended use and primary purpose of enabling radiotherapy professionals to efficiently design and analyze proton radiotherapy treatment plans. This Astroid Planning App leverages the existing .decimal Astroid Dosimetry App [FDA 510(k) K150547), which is a library of treatment planning functions accessed through the Thinknode® cloud services framework, for device creation, dose calculation, optimization, and all other dosimetry and processing calculations. Since the Astroid Dosimetry App is responsible for performing the calculations, the scope of this Astroid Planning App is to be the user interface for end users to input treatment planning data and review the results. Typical indications for the treatment of persons with cancer, over a wide range of potential disease locations. In the most common use case of the software, users will import patient data from existing imaging software programs, manage physician prescription and intent information, develop a proton treatment plan, and analyze the plan to determine how well it meets the physician's goals. Since the critical treatment planning functions are handled outside this software application, by a software of known quality and pedigree, the primary and most frequently used functions of this software are the record keeping service (for patient data storage), user interface controls, and visualization tools. Furthermore, since the accuracy of information computed and displayed by an application such as this is very important to the proper treatment of patients, it is critical that users have the appropriate educational and clinical experience backgrounds to adequately understand and use the product. Additionally, since each radiotherapy treatment machine produces a unique beam of radiation, there is much responsibility on the end users to adequately commission and test this software over the full range of expected treatment conditions before the system is utilized for patient treatment.

The primary purpose of the Astroid Planning App device is for facilitating the planning and analysis of proton radiation therapy treatments. The Astroid Planning App device is an interactive end user application in which the user interacts with the interface to perform proton treatment planning tasks. The data constructed in the Astroid Planning App device will be used as inputs to the Astroid Dosimetry App device [FDA 510(k) K150547], which is the foundational proton dosimetry calculation library that contains all algorithms and calculation processing for the proton treatment planning. The Astroid Planning App device composes and otherwise constructs the calculation requests required for the development of the proton treatment plan, leveraging the functions externally located in the Astroid Dosimetry App to then perform the requested calculations.