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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 provided text does not describe the acceptance criteria and the study that proves the device meets those criteria. It focuses on the device's indications for use, technological characteristics, and a summary of non-clinical testing, stating that "Clinical testing was not performed."

Therefore, I cannot extract the requested information from the provided text.

Here's a breakdown of why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: The text mentions non-clinical testing but does not specify any acceptance criteria or report specific performance metrics for the device against these criteria.
2. Sample sized used for the test set and the data provenance: Since no clinical testing was performed, there is no test set in the context of human data. The non-clinical testing mentioned doesn't detail sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set with human ground truth was mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no clinical test set with human ground truth was mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is for designing beam-shaping blocks and is not an AI-assisted diagnostic or interpretation tool for human readers. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The text mentions "Clinically oriented validation test cases were written and executed by .decimal personnel and hospital-based testing partners where this device was deemed safe and effective for clinical use." However, it doesn't specify if this was a standalone algorithm performance test. The device itself is described as an "iPad application that guides users through the process...and provides tools that allow users to digitize the treatment area," implying a human-in-the-loop process for most of its functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not specified for the non-clinical tests.
8. The sample size for the training set: No information about a training set for an AI/ML algorithm is provided. The device uses "proven off-the-shelf optical scanning technology" but the software itself is described in terms of tools and workflows rather than an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable as no training set information is provided.

The document mainly serves as an FDA 510(k) clearance letter and summary, which focuses on demonstrating substantial equivalence to a predicate device and outlining the device's intended use and technological characteristics rather than providing detailed study results with acceptance criteria.

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