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The SeaSpine 7D Navigation Instruments are intended to be used during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine 7D Navigation Instruments are specifically designed for use with the 7D Surgical System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure can be identified.

The SeaSpine 7D Navigation Instruments are used during the preparation and placement of SeaSpine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine 7D Navigation Instruments are wireless optically tracked and specifically designed for use with the 7D Surgical system.

The SeaSpine 7D Navigation Instruments utilize 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. Position and orientation data of tracked Spinal Instruments are linked to the preoperative scan data using the 7D Surgical System workstation.

The provided text concerns the FDA 510(k) premarket notification for the "SeaSpine 7D Navigation Instruments." This submission focuses on the mechanical compatibility and accuracy of newly designed instruments within an existing navigated surgical system (7D Surgical System), rather than an AI/ML-driven diagnostic or prognostic device.

Therefore, many of the requested criteria related to AI/ML device validation (e.g., number of experts for ground truth, adjudication methods, MRMC studies, training set details) are not applicable to this type of device and the information is not provided in the submission. The device is a surgical instrument that is optically tracked and mechanically connects to an existing navigation system.

Here's an analysis of the provided information relative to your request:

Acceptance Criteria and Device Performance (Mechanical & Positional Accuracy)

The acceptance criteria are primarily focused on system compatibility, mechanical design, and positional accuracy of the instruments.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number of distinct "cases" or "patients" for positional accuracy testing. The document states "phantom models" were used. It implies repeatable tests were run to demonstrate accuracy, but the number of phantom models or repetitions is not specified.
• Data Provenance:
  • Country of Origin: Not specified but likely conducted in North America (given the submitter's location in Canada and the FDA clearance).
  • Retrospective/Prospective: Neither. The studies were non-clinical performance surgical simulations conducted on phantom models. This is a prospective testing methodology for device performance on inanimate objects.

3. Number of Experts Used to Establish Ground Truth and Qualifications of those Experts

• Not Applicable. This is not an AI/ML diagnostic device requiring expert interpretation for ground truth. Ground truth for positional accuracy testing (TRE/ATE) would be established by precise physical measurements using metrology equipment on the phantom models, not human expert consensus.

4. Adjudication Method for the Test Set

• Not Applicable. As above, no human expert consensus or adjudication was involved in establishing ground truth for mechanical 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

• No. This is not an AI/ML diagnostic or image-based assistance device. It's a suite of surgical instruments used with a navigation system. MRMC studies are not relevant for this type of device.

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

• Partially Applicable / Adapted Interpretation: While not an AI algorithm, the device's accuracy (its "standalone" performance within the larger navigation system) was assessed through "Non-Clinical Accuracy" tests on phantom models. This involved evaluating the positional and angular accuracy of the SeaSpine instruments when used with the 7D Surgical System. The ASTM F2554-10 standard is for measuring the positional accuracy of computer-assisted surgical systems. The "standalone" performance here refers to the system's ability to accurately track and report the position of the instruments relative to the "ground truth" on the phantom.

7. The Type of Ground Truth Used

• Precision Measurement/Metrology on Phantom Models: Ground truth for Target Registration Error (TRE) and Angular Trajectory Error (ATE) is established by precise physical measurements of the actual position of fiducials or targets on the phantom model, compared against the position reported by the navigation system. This is a form of engineered ground truth for spatial accuracy.

8. The Sample Size for the Training Set

• Not Applicable. This is not a machine learning device that requires a "training set." The instruments are designed and verified based on engineering principles and compatibility with an existing optical tracking system.

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

• Not Applicable. As above, no training set for a machine learning model.

In summary, the provided document details the non-clinical testing of a surgical navigation instrument for its compatibility, safety, and mechanical positional accuracy with an existing stereotactic system. It does not describe the validation of an AI/ML-driven diagnostic or prognostic device, hence many of the requested criteria are not present or applicable. The key validation data provided relates to meeting ASTM standards for positional accuracy and demonstrating compatibility with the predicate device's system.

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