(83 days)
The 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical 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 Medtronic Universal Drill Guide, 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 Medtronic Stealth Station, the system tracks the position and orientation of the Medtronic Universal Drill Guide.
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 Medtronic Universal Drill Guide, utilizes commercially available passive reflective marker spheres [Manufactured by NORTHERN DIGITAL, INC.; 510(k) K033621] 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 verification, and navigation.
Here's a breakdown of the acceptance criteria and study information for the 7D Surgical System, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| System Verification: Design requirements specifications of 7D Surgical System under test case protocols. | Conclusion: Verification successful, all design requirements have been fulfilled. |
| System Validation: Indications For Use and Customer Requirements of the 7D Surgical System under simulated use case situations. | Conclusion: Validation successful, all user needs met. |
| Usability: Validate the 7D Surgical System with respect to user errors. | Conclusion: Validation successful, device safe and effective with respect to user errors. |
| Safety regarding risk analysis: Implementation and effectiveness of all risk control requirements specified in the 7D Surgical System risk analysis. | Conclusion: Risk Control requirements are effective and mitigate the associated risks to an acceptable level. |
| Product Safety standards: Compliance with recognized standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-41, IEC 60825-1, ISO 10993-1, and ISO 17665-1). | Conclusion: Compliance with recognized standards has been verified in the previous application K162375. Previous test results have not been affected by this change. |
| Non-Clinical Accuracy: System's accuracy tested using the 7D Surgical System on phantom models following ASTM F2554-10 Standard Practice and Target Registration Error. | Conclusion: All accuracy specifications have been met for the Medtronic Universal Drill Guide. Accuracy testing for the currently cleared Reference Frame, Awl and Pedicle Probe have been verified in previous application K162375. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical sample size. The testing was conducted on "phantom models" in a "clinical simulated environment." The number of phantom models or specific test cases performed for accuracy is not quantified.
- Data Provenance: The study was "non-clinical" and involved "phantom models." There is no indication of human patient data (retrospective or prospective) or country of origin for such data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the study was non-clinical, using phantom models. Ground truth for accuracy was established through physical measurements ("measured physically or otherwise") rather than expert consensus on medical images or clinical outcomes.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as the study was non-clinical, focusing on device accuracy measured against a physical ground truth, not requiring expert adjudication of interpretations.
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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 was a non-clinical performance study of a surgical navigation system's accuracy, not an MRMC study comparing human reader performance with or without AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The "Non-Clinical Accuracy" testing evaluated the system's accuracy (algorithm and hardware) in determining positional information against a ground truth on phantom models. While a human surgeon would ultimately use the system clinically, this specific test isolated the device's inherent navigational accuracy.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for accuracy testing involved comparing the position reported by the image-guided surgery system to the "ground truth position measured physically or otherwise." This implies a physical measurement or established reference standard on the phantom models.
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The sample size for the training set:
- Not applicable. This document describes verification and validation activities for a new software compatibility feature (Medtronic Universal Drill Guide) for an existing surgical navigation system. It does not refer to a machine learning model that would require a distinct "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for a machine learning algorithm.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).