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The Anatase Spine Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery.

Example procedures include but are not limited to:

Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

The Anatase Spine Surgery Navigation System, also known as an Image Guided System, is comprised of a platform, clinical software, surgical instruments, and a referencing system. The system uses wireless optical tracking technology to track the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The system helps guide surgeons during spine procedures such as spinal fusion. The software functionality in terms of its feature sets are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views.

The provided text describes the Anatase Spine Surgery Navigation System and its 510(k) submission to the FDA. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed clinical performance data, acceptance criteria, and ground truth establishment for a specific AI-driven diagnostic or prognostic task.

However, based on the Accuracy section under "Performance Data Verification and validation activities," we can infer the acceptance criteria and the nature of the study for positional accuracy.

Here's an analysis based on the provided text, while acknowledging limitations due to the nature of the document (a 510(k) summary for device clearance):

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the positional accuracy of the system is evaluated in accordance with ASTM F2554-18. While the specific numerical acceptance criteria and the reported performance values are not provided in this summary document, the fact that it passed verification and validation implies that it met predefined criteria based on this standard.

To get the specific values, one would need to consult a more detailed technical report or the full 510(k) submission, which is not fully available here.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size used for the positional accuracy test set nor the data provenance (e.g., country of origin, retrospective/prospective). This information is typically found in detailed test reports, not a 510(k) summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not mention the use of experts to establish ground truth for the positional accuracy testing. Positional accuracy testing typically relies on metrology equipment and precise physical measurements, not expert human evaluation.

4. Adjudication Method for the Test Set:

Not applicable, as ground truth for positional accuracy is established by metrological methods, not human adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The document states "The Anatase Spine Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants..." suggesting it is a tool for surgeons rather than an AI diagnostic device that assists human readers in interpreting images.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone performance evaluation regarding positional accuracy was conducted for the device. The text states, "Accuracy: Positional accuracy of the system is evaluated in accordance with ASTM F2554-18." This refers to the objective measurement of the system's tracking and navigation capabilities.

7. Type of Ground Truth Used:

For positional accuracy, the ground truth would be established through metrological measurements using calibrated instruments and reference standards, as dictated by ASTM F2554-18. It is not expert consensus, pathology, or outcomes data in this context.

8. Sample Size for the Training Set:

The document does not mention a "training set" in the context of machine learning or AI. This device is a navigation system that uses optical tracking and image registration, implying a more traditional engineering validation process rather than a deep learning model requiring a large training dataset for a diagnostic task.

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

Not applicable, as there is no mention of a training set for an AI/machine learning model to establish ground truth.

Summary of Device Performance Study Information based on the provided text:

The information primarily focuses on regulatory conformity and substantial equivalence. For specific performance studies, the key takeaway is:

• Study Type for Accuracy: Evaluation of positional accuracy.
• Standard Used: ASTM F2554-18.
• Ground Truth for Accuracy: Metrological measurements (implied by the standard).
• Result: The device met performance requirements, indicating it passed the accuracy criteria.

The document does not provide the detailed numerical results, sample sizes, or specifics of the test setup beyond referencing the standard.

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