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The 7D Surgical System Percutaneous Application 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 minimally invasive spine surgery. The system performs Percutaneous image guided surgery by acquiring an intra-operative tomographic scan of the patient with the 7D Surgical Flash Frame attached to the patient's skin over the incision drape in the region of interest where the spine surgery is to be performed. In addition, the intra-operative tomographic scan is taken with the 7D Surgical Reference Frame rigidly attached to either the spine or iliac crest. The 7D System then generates a three-dimensional (3D) image of the surgical site and the 7D Flash Frame. Registration is performed by the system software registering points from the 7D Flash Frame generated from the 3D intra-operative tomographic scan to the 3D structured light image generated by the system.

The provided document describes the 7D Surgical System - Percutaneous Application (7D Flash Frame), a stereotaxic image guidance system for spinal surgery. The safety and effectiveness of this device are demonstrated through non-clinical performance data.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "All accuracy specifications have been met for the Percutaneous Application" and "All non-clinical tests successfully passed demonstrating that the subject device performs as safely and effectively as the predicate device." However, specific numerical acceptance criteria (e.g., a defined threshold for Target Registration Error) and the exact reported device performance values against these criteria are not explicitly provided in the given text. The table above can only reflect the general qualitative statements made.

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

• Sample Size for Test Set: Not specified. The document mentions "phantom models" for accuracy testing but does not provide details on the number of phantoms, tests, or specific scenarios.
• Data Provenance: The testing was "conducted on phantom models in a simulated environment." This indicates simulated data rather than patient data. The country of origin of the data is not specified but given the company's location, it's likely Canada. The study was prospective as it involved conducting new tests.

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

Not applicable/Not specified. The ground truth for the "Non-Clinical Accuracy" testing using "Target Registration Error (TRE)" was established by "the ground truth position measured physically or otherwise." This implies a physical measurement standard on the phantom model rather than expert opinion. Therefore, no human experts were explicitly used to establish ground truth for the accuracy measurements described.

4. Adjudication method for the test set:

Not applicable/None specified. As the ground truth was established through physical measurements on phantom models, there's no mention of human adjudication for the test set results.

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:

No. The document explicitly states: "A clinical trial was not required to demonstrate safety and effectiveness of the 7D Surgical System. Clinical validation is unnecessary as the 7D Surgical System introduces no new indications for use, and device features are equivalent to the previously cleared predicate device identified." This indicates that no human readers or clinical subjects were involved, and therefore, no MRMC study or assessment of human reader improvement with/without AI assistance was conducted.

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

Yes, implicitly. The "Non-Clinical Accuracy" testing, particularly the "Target Registration Error" evaluation on phantom models, describes the performance of the system (algorithm and hardware) in a simulated environment without human surgical intervention being part of the performance measurement itself. The system's ability to register and track accurately in this controlled setting represents its standalone performance.

7. The type of ground truth used:

The ground truth used for the "Non-Clinical Accuracy" testing was the "ground truth position measured physically or otherwise" on phantom models. This is a form of physical measurement/reference standard in a simulated environment.

8. The sample size for the training set:

Not specified. The document focuses on verification and validation testing and does not provide information about a separate training set or its sample size for the device's development or machine learning components (if any, though the "structured light images" and "DICOM data" suggest image processing and registration).

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

Not specified. As the training set details are not provided, how its ground truth was established is also not mentioned.

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