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The Surgical Theater, LLC SuRgical Planner (SRP) is intended for use as a software interface and image segmentation system for the transfer of image information from a CT, MR, or X-ray 3D Angiography (XA) medical scanner to an output file. It can also be used for pre-operative planning and surgical training in a virtual environment.

The SuRgical Planner (SRP) is intended for use as a software interface and image segmentation system for the transfer of imaging information from a CT, MR or X-ray 3D Angiography (XA) medical scanner to an output file. It can also be used for pre-operative planning and surgical training in a virtual environment.

The SuRgical Planner is not intended to be used for diagnosis.

The SRP software has the ability of creating 3D models of the patient data from 2D scan slices. Additionally, it provides the user with the ability to input, display, color, and manipulate the 2D scan slices via a 3D representation. The software transforms 2D medical images into a dynamic interactive 3D scene with multiple point of views on a high-definition (HD) touch screen monitor. The use of a virtual reality (VR) headset provides the surgeon a 3D stereoscopic display of the same scene inside the VR headset. While wearing the VR headset, the surgeon can perform a virtual / simulated "fly-through" inside the 3D scene using controllers to perform such actions as rotate, zoom in and zoom out. The SRP with VR headset and controllers is not intended for use during surgery. The SRP is intended for use for pre-operative planning.

The SRP product does not include any custom hardware and is a software-based device that runs on a high-performance desktop PC assembled using "commercial off-the-shelf" components that meet minimum performance requirements. The design is based on an advanced, touch screen friendly, Graphical User Interface (GUI) that runs an underlying simulation engine to process medical images in DICOM format, and an image generator software engine.

The provided text is a 510(k) summary for the Surgical Theater, LLC SuRgical Planner (SRP) software. It describes the device, its intended use, comparison to a predicate device, and performance data. However, the document primarily focuses on regulatory compliance and substantial equivalence rather than a detailed study evaluating the device's performance against specific acceptance criteria.

Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, sample sizes for test and training sets, expert qualifications, and ground truth establishment is not available in the provided text. The document states that "Software verification and validation testing were conducted" and that "A formal verification and validation plan was executed to confirm that the modified SRP continues to meet its intended use and performance requirements." However, it does not provide the specifics of these plans or their results in a way that directly answers the questions about acceptance criteria and performance metrics.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Study Details for SuRgical Planner (SRP)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not specified in the provided document. The document mentions "Software verification and validation testing were conducted," but details on the number of cases or images used in these tests are absent.
• Data Provenance: Not specified. The document states the device processes DICOM images from CT, MR, or X-ray 3D Angiography (XA) medical scanners, but does not indicate the source (e.g., country, hospital, retrospective/prospective) of the data used for testing.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document states the device is for "pre-operative planning and surgical training in a virtual environment," implying surgical expertise might be relevant, but this is not confirmed for ground truth establishment.

4. Adjudication Method for Test Set

• Adjudication Method: Not specified. The document outlines general software verification and validation but does not detail how ground truth was established or if an adjudication process was involved for performance evaluation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned in the provided text. The document focuses on the device's technical specifications and regulatory equivalence, not on evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: Yes, implicitly. The document states that the "SRP was fully tested, verified and validated by Surgical Theater as part of its own internal design control requirements" to "meet its intended use and performance requirements." While details on specific metrics are missing, this implies a standalone evaluation of the software's functionality and accuracy in image segmentation and 3D model generation, which are core algorithmic tasks. However, explicit performance metrics (e.g., segmentation accuracy, speed) are not provided.

7. Type of Ground Truth Used

• Type of Ground Truth: Not specified. Given the device's function involves image segmentation and 3D model generation, ground truth would likely relate to the accuracy of these outputs against a reference. However, the method for establishing this reference (e.g., manual segmentation by experts, phantom scans with known anatomy) is not detailed.

8. Sample Size for the Training Set

• Sample Size: Not specified. The document does not provide information about a training set, as the SRP functions primarily as an image processing and visualization tool, rather than a machine learning model that requires explicit training data in the traditional sense. It processes existing medical images.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not applicable, as detailed training set information is not provided and the device description does not explicitly mention machine learning components that require a training set with established ground truth in the context of predictive or diagnostic tasks. The "training" aspect mentioned in the document refers to surgical training in a virtual environment using the device, not training of the device itself.

In summary, the provided document serves as a regulatory submission emphasizing substantial equivalence and general safety/effectiveness through internal verification and validation processes. It lacks the quantitative performance data and detailed study designs typically found in clinical efficacy studies that would address specific acceptance criteria with measured outcomes.

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