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The 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified.

The 7D Surgical System is intended for use as a stereotaxic image guided surgical navigation system during spine surgery. The system provides image registration between preoperative scan data and data captured intraoperatively from the 7D Surgical System structured light scanner and/or user selected points. The system provides guidance data by tracking and displaying the position and orientation of wireless optically tracked Spinal Instruments including the 7D Surgical Pedicle Probe and Awl, now including the FlashLock and Flex Rod, relative to the patient. Position and orientation data of tracked Spinal Instruments are linked to the preoperative scan data using the 7D Surgical System workstation. The system is intended to be used as the primary surgical luminaire for image guided surgery. Similar to the previously cleared 7D Surgical System, the system tracks the position and orientation of a FlashLock and Flex Rod.

The system is intended to be used for both image fusion and navigation for neurological applications where reference to a rigid structure can be identified relative to a preoperative image data of the anatomy.

The Tracking System enables the surgeon to view the position and orientation of 7D Surgical System Spinal Instruments relative to registered preoperative image data while performing the surgical procedure. Each of the 7D Surgical System instruments, including the FlashLock and Flex Rod, utilizes commercially available passive reflective marker spheres to determine the position and orientation of instruments. Each tracked Instruments requires a unique marker position configuration to enable the tracking system to distinguish the tools from one to the other.

The Software links all system components and displays navigational data to the surgeon. lt provides methods for loading preoperative scans and guides the surgeon through the process of surface model creation, structured light acquisition, registration, registration verification, and navigation.

The provided text describes a 510(k) submission for the 7D Surgical System with new instruments (FlashLock and Flex Rod). It does not contain information about an AI-powered device or a multi-reader, multi-case (MRMC) comparative effectiveness study. Therefore, I cannot fully answer all aspects of your request as they pertain to AI device performance.

However, I can extract the information provided regarding the device's acceptance criteria and the study conducted, focusing on the available details.

Here's a breakdown of the information provided in the document:

1. A table of acceptance criteria and the reported device performance

The document mentions "Non-Clinical Accuracy" testing as proof that "All accuracy specifications have been met for the FlashLock and Flex Rod." However, it does not provide specific numerical acceptance criteria or the exact reported performance values (e.g., specific TRE or ATE values). It only states that the testing was performed using ASTM F2554-10 and Target Registration Error (TRE).

2. Sample size used for the test set and the data provenance

The document mentions "phantom models" for non-clinical performance surgical simulations. It does not specify the sample size of these phantom models or their provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts to establish ground truth for the test set. The ground truth appears to be established by physical measurements on phantom models, as indicated by the description of TRE and ATE.

4. Adjudication method for the test set

Not applicable, as expert adjudication is not mentioned for establishing ground truth or evaluating the device's accuracy on phantom models.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a stereotaxic surgical navigation system, not an AI-powered diagnostic or assistive tool for human readers in the sense of image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The performance testing (Non-Clinical Accuracy) was conducted on the "System's accuracy... using the 7D Surgical System on phantom models." This can be considered a form of standalone performance evaluation for the navigation system, focusing on its accuracy in guiding instruments. However, it's not an "algorithm-only" performance in the context of an AI device interpreting data. The system itself is the "standalone" entity being evaluated for its navigational accuracy.

7. The type of ground truth used

The ground truth used for accuracy evaluation (TRE and ATE) was based on: "the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise." This implies a physically measured ground truth on phantom models, not derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

The document does not mention a "training set" as would be applicable to machine learning or AI models. This system is described as a "stereotaxic image guidance system" and its functionality seems to be based on established engineering principles of tracking and navigation, rather than a learned model.

9. How the ground truth for the training set was established

Not applicable, as a training set for an AI model is not mentioned.

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