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aprevo® Digital Workflow software is intended to view, store, and manipulate 3-D models to visualize surgical plans for spinal alignment. The device inputs a 3-D spine model which is used by trained, medically knowledgeable design personnel in conjunction with inputs from healthcare professionals to produce 3-D models of spinal correction and anatomical measurements. The device outputs are used by healthcare professionals for placement of surgical implants.

The aprevo® Digital Workflow is a proprietary software tool that visualizes and provides measurements of a healthcare professional's surgical plan for a spinal alignment. The software is used to input the patient's spine model, then view, store and measure the 3D spine model to create a visual representation of the desired surgical plan. The software is used to export the visualization of the surgical plan along with associated measurements. The Subject Device is operated by trained, medically knowledgeable Carlsmed design personnel while the output is reviewed and approved by a healthcare professional.

The provided text is a 510(k) summary for the aprevo® Digital Workflow device. It describes the device's indications for use, technological characteristics, and a brief section on performance data. However, it does not contain the detailed information required to answer the specific questions about acceptance criteria and the study proving the device meets those criteria.

The "PERFORMANCE DATA" section is very general, stating:
"The Subject Device has been evaluated in accordance with internal software specifications and applicable performance standards through the software development and verification and validation procedures to ensure performance according to specifications, user requirements, and the FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions."

It also mentions:
"In addition, the measuring function of the Subject Device was evaluated in bench testing using in-silico phantoms with known values."

This information is insufficient to complete the requested table and answer the detailed questions about the study design, sample sizes, expert involvement, and ground truth establishment. The document explicitly states that the software is used by "trained, medically knowledgeable Carlsmed design personnel" and the output is "reviewed and approved by a healthcare professional," implying a human-in-the-loop workflow, but it doesn't provide a comparative effectiveness study.

Therefore, I cannot provide the detailed information requested in the format of the questions because it is not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device based on intended use and technological characteristics, rather than a detailed performance study with specific acceptance criteria and results.

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