Search Results

The EXCELSIUS GPS™ is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

The EXCELSIUS GPS™ is a Robotic Positioning System that includes a computer controlled robotic arm, hardware, and software that enables real time surgical navigation and robotic guidance using radiological patient images (preoperative CT, intraoperative CT and fluoroscopy), using a dynamic reference base and positioning camera. The navigation and quidance system determines the registration or mapping between the virtual patient (points on the patient images) and the physical patient (corresponding points on the patient's anatomy). Once this registration is created, the software displays the relative position of a tracked instrument, including the end effector of the robotic arm, on the patient images. This visualization can help guide the surgeon's planning and approach. As an aid to visualization, the surgeon can plan implant placement on the patient images prior to surgery. The information of the plan coupled with the registration provides the necessary information to provide visual assistance to the surgeon during free hand navigation or during automatic robotic alignment of the end effector. During surgery, the system tracks the position of GPS compatible instruments, including the end effector of the robotic arm, in or on the patient anatomy and continuously updates the instrument position on patient images utilizing optical tracking. Standard non-navigated metallic instruments that fit through the quide tube at the selected trajectory may be used without navigation while the quide tube is stationary, for uses such as bone preparation (e.g. rongeurs, reamers etc.) or placing implants (e.g. rod inserters, locking cap drivers) that are not related to screw placement. Navigation can also be performed without guidance. System software is responsible for all motion control functions, navigation functions, data storage, network connectivity, user management, case management, and safety functions. EXCELSIUS GPSTM surgical instruments are non-sterile, re-usable instruments that can be operated manually or with the use of the positioning system. EXCELSIUS GPS™ instruments consist of registration instruments, patient reference instruments, surgical instruments, and end effectors. Registration instruments incorporate arrays of reflective markers, and are used to track patient anatomy and surgical instruments and implants; components include the verification probe, surveillance marker, surgical instrument arrays, intra-op CT reqistration fixture, fluoroscopy registration fixture, and dynamic reference base (DRB). Patient reference instruments are either clamped or driven into any appropriate rigid anatomy that is considered safe and provides a point of rigid fixation for the DRB. Surqical instruments are used to prepare the implant site or implant the device, and include awls, drills, drivers, taps, and probes, End effectors are wirelessly powered quide tubes that attach to the distal end of the robotic arm and provide a rigid structure for insertion of surgical instruments.

The provided document is a 510(k) summary for the EXCELSIUS GPS™ robotic positioning system. It describes the device, its intended use, and a comparison to predicate devices, along with various performance testing categories. However, it does not contain acceptance criteria or detailed results from a specific study proving the device directly meets acceptance criteria for accuracy or clinical outcomes.

Instead, the document broadly describes categories of performance testing that were conducted to ensure safety and efficacy, and confirms compliance with recognized standards.

Therefore, many of the requested details about specific acceptance criteria and a study proving them cannot be extracted from this document. I will provide what can be gleamed and note where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states that "Verification and validation testing was conducted... to confirm that the device meets performance requirements," but it does not explicitly list what those performance requirements (acceptance criteria) were in terms of specific quantitative metrics (e.g., accuracy in mm, successful screw placement rate).

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

• Sample Size for Test Set: Not specified in the provided document. The document mentions "Surgical simulations conducted on phantom models" and "Human cadaveric quantitative validation under clinically relevant scenarios" but does not give the number of cases, studies, or specific phantom/cadaver units used.
• Data Provenance: Not specified. It's likely these tests were conducted internally by Globus Medical or a contracted research organization, but no country of origin or whether it was retrospective/prospective is mentioned. Given the nature of cadaveric and phantom studies, they are typically prospective experimental designs.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Not specified. The document does not describe a method for establishing or adjudicating ground truth in a clinical or expert review context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on how human readers improve with AI vs. without AI assistance is not described in this document. The EXCELSIUS GPS is a robotic positioning system for surgical guidance, not an AI-assisted diagnostic imaging device for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, the performance testing described (e.g., "Non-clinical system, software, and instrument verification and validation," "Surgical simulations conducted on phantom models," "Human cadaveric quantitative validation") generally represents standalone performance of the device's accuracy and functionality. The system "determines the registration or mapping," "displays the relative position of a tracked instrument," and "provides visual assistance to the surgeon," implying the device's inherent capability to perform these functions. Specific metrics for this standalone performance (e.g., tracking accuracy, registration accuracy) are not detailed.

7. The Type of Ground Truth Used

• For the performance testing mentioned:
  • For "Surgical simulations on phantom models" and "Human cadaveric quantitative validation," the ground truth would likely be established by direct measurement using precision instruments (e.g., coordinate measuring machines, highly accurate imaging) to compare the device's reported position/trajectory against the actual physical position/trajectory.
  • For compliance assessments (electrical safety, EMC, biocompatibility, software V&V), the "ground truth" is adherence to the specified international standards and FDA guidance.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This document describes a surgical guidance system, not a machine learning model that would typically have a distinct "training set" in the common sense of AI/ML algorithm development. While software development (which is discussed) involves testing, there's no mention of a traditional machine learning training set.

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

• Not applicable/Not specified (refer to point 8).

Ask a specific question about this device