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The SYMPHONY Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:

• the use of SYMPHONY OCT System is indicated,
• the use of stereotactic surgery may be appropriate, and
• reference to a rigid anatomical structure, such as a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.

These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments can be:

• pre-calibrated with the VELYS™ SPINE Navigation using the VELYS™ SPINE Instrument Arrays,
• pre-calibrated and/or manually calibrated with the Brainlab Navigation System using the UNAS Navigation Arrays,
• manually calibrated with other navigation systems, using tracking arrays supplied by the navigation system manufacturer.

The SYMPHONY Navigation Ready Instruments are intended to support indicated cervical and thoracic polyaxial screw placement.

The SYMPHONY™ Navigation Ready Instruments are reusable instruments used for the preparation for and insertion of SYMPHONY OCT screws, in either open or percutaneous procedures. These instruments are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling.

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REAL INTELLIGENCE CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include:

• unicondylar knee replacement (UKR),
• total knee arthroplasty (TKA),
• revision knee arthroplasty, and
• total hip arthroplasty (THA).

The subject of this Special 510(k) is REAL INTELLIGENCE CORI (CORI), a robotic-assisted orthopedic surgical navigation and burring system. CORI uses established technologies of navigation via a passive infrared tracking camera. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, the system aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location. For knee applications, CORI then aids the surgeon in executing the surgical plan by controlling the cutting engagement of the surgical bur.

CORI knee application software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes:

• Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting.
• Speed control regulates the signal going to the tool control unit itself and limits the speed of the drill if the target surface is approached.

Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.

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The Stealth AXIS Surgical System, with the Stealth AXIS Cranial clinical application, is intended for precise positioning of surgical instruments and as an aid for locating anatomical structures in open, minimally invasive, and percutaneous neurosurgical procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.

This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures):

• Tumor resections
• General ventricular catheter placement
• Pediatric ventricular catheter placement
• Depth electrode, lead, and probe placement
• Cranial biopsies

The Stealth AXIS Cranial clinical application works in conjunction with the Stealth AXIS Surgical System. The Stealth AXIS Cranial clinical application helps guide surgeons during cranial procedures such as biopsies, tumor resections, shunt placements and depth electrode and probe placement. The system tracks the position of instruments in relation to surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient.

Patient images are transferred to the system, and the Stealth AXIS Cranial clinical application displays the image of the patient anatomy from a variety of perspectives (axial, sagittal, coronal, oblique) and 3-dimensional (3D) renderings of anatomical structures. During navigation, the Stealth AXIS Surgical System identifies the tip location and trajectory of the tracked instrument on images and models the user has selected to display on the monitor. The surgeon may also create and store one or more surgical plan trajectories before surgery and simulate progression along these trajectories. During surgery, the Stealth AXIS Cranial clinical application can display how the actual instrument tip position and trajectory relate to the pre-surgical plan, helping to guide the surgeon along the planned trajectory.

The provided FDA 510(k) clearance letter and summary for the Stealth AXiS Cranial clinical application offers surprisingly limited detail on the specific acceptance criteria and the study that proves the device meets them, especially concerning the AI/ML components. However, I will extract and infer as much as possible from the provided text to answer your questions.

It's important to note that the clearance letter itself doesn't present the full study details, but rather summarizes the findings that Medtronic provided to the FDA. Many of the specific details you requested (like exact sample sizes for test sets, data provenance, number and qualifications of experts, and adjudication methods for ground truth) are not explicitly stated in this public document. I will highlight what is present and what is missing.

Acceptance Criteria and Device Performance Study for Stealth AXiS Cranial Clinical Application

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on overall system accuracy requirements and general software validation. For the AI-enabled "Autotracts" feature, the acceptance criteria are less formally quantified in the provided text.

2. Sample Size for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated in the document for either the general system accuracy or the AI Autotracts feature. The document only mentions "withheld datasets" for validation of the AI model.
• Data Provenance:
  • For System Accuracy: "representative worst-case configuration" implies laboratory testing, not patient data in this context.
  • For AI Autotracts: "hundreds of images from internal studies and public datasets, spanning normal and pathological cases." The country of origin and whether the data was retrospective or prospective are not specified.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not explicitly stated. The document mentions "expert-reviewed gold standard annotations" for the training/validation of the Autotracts and "expert review" to assess performance.
• Qualifications of Experts: Not explicitly stated. It is implied that these are experts in brain anatomy, neuroimaging, and neuronavigation, but specific qualifications (e.g., "Radiologist with 10 years of experience") are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. For the expert-reviewed ground truth, it is unknown if a single expert provided the ground truth, if consensus was reached among multiple experts (e.g., 2+1, 3+1), or if there was no formal adjudication process described beyond "expert-reviewed."

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was explicitly NOT performed. The document states, "No clinical testing was performed." The usability validation was done by "representative users," but this is distinct from a clinical MRMC study designed to measure the effect size of AI assistance on human reader performance.
• Effect Size of AI vs. Without AI Assistance: Since no clinical testing or MRMC study was performed, there is no reported effect size of how much human readers improve with AI vs. without AI assistance in this document.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: For the AI-enabled "Autotracts" feature, the description of "Performance was assessed leveraging expert review to ensure reliability" suggests some form of standalone evaluation against expert-derived ground truth. However, specific quantitative standalone metrics (e.g., sensitivity, Dice coefficient for segmentation, average distance error for tractography) are not provided. The phrase "Users retain control by adjusting tract appearance... and ultimately verifying tracts before proceeding" also highlights that the AI's output is intended for human-in-the-loop verification, not necessarily as a standalone diagnostic or planning output without review.

7. Type of Ground Truth Used

• For System Accuracy: Physical measurements against known standards in a "worst-case configuration."
• For AI Autotracts: "expert-reviewed gold standard annotations" for training and validation, and "expert review" for performance assessment. This implies expert consensus on the definition of white matter tracts based on diffusion MRI images. It does not mention pathology or outcomes data for ground truth for this specific AI feature.

8. Sample Size for the Training Set

• Training Set Sample Size: Not explicitly stated. The document mentions "Training and validation used hundreds of images from internal studies and public datasets." It does not separate the exact number for training versus validation.

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

• Ground Truth Establishment for Training Set: The ground truth for the AI Autotracts training set was established through "expert-reviewed gold standard annotations." This indicates that human experts manually identified or delineated the white matter tracts on the diffusion MRI images, and their work was considered the "gold standard" for the AI model to learn from.

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The CUVIS-joint is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with preoperative planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.

The preoperative planning software and robotic surgical tool are used as an alternative to manual planning and resecting techniques for the distal femur and proximal tibia preparation in primary total knee arthroplasty (TKA).

The CUVIS-joint is indicated for orthopedic procedures in which resecting techniques used for the distal femur and proximal tibia may be considered to be safe and effective and where references to rigid anatomical structures may be made.

The CUVIS-joint is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The CUVIS-joint facilitates accurate positioning of TKA implants, relative to these alignment axes.

The CUVIS-joint is compatible with the following Knee Implant System:
-United U2 Knee System

The CUVIS-joint is a three-dimensional, graphical, preoperative planner and implementation tool for treatment of patients who require total joint arthroplasty. The device is intended as an alternative to manual template planning and preparation of the bone with patients requiring primary total knee arthroplasty (TKA).

The CUVIS-joint consists of two main components: 1) the Planner which is a three-dimensional (3D) preoperative planning workstation which uses preoperative CT scans of patient anatomy to aid a surgeon in planning the position and orientation of the implant components relative to 3D models of the patient's anatomy, and 2) the Robotic Arm Tool which executes the surgical plan and includes a an electromechanical arm, an arm base including control electronics and computer, optical tracking system, a display monitor, operating software, pendant control, and tools and accessories. When used according to the Instructions for Use (IFU), the CUVIS-joint enables precise implant positioning possible before and during TKA surgical procedures.

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The TiLink-L Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The TiLink-L Navigation Instruments are intended to be used with the TiLink-L Joint Fusion System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System S8, 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, such as the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy. Fluoroscopy is intended to be used for navigating final implant placement.

The TiLink-L Navigation Instruments include a Drill Bit, Drill Guide, and Inserter and are specifically designed to be used with the TiLink-L Joint Fusion System Implants. The TiLink-L Navigation Instruments are to be used with the NavLock Instruments and Medtronic StealthStation System S8. The TiLink-L Joint Fusion System is provided sterile (single use) and non-sterile (reusable) and the TiLink-L Navigation Instruments are manufactured from Stainless Steel per ASTM F899.

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The EUROPA™ Posterior Cervical Fusion Navigated Instruments are intended to be used in the preparation and placement of the EUROPA™ Posterior Cervical Fusion screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the stereotactic navigation system Medtronic StealthStation® 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, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The EUROPA™ Posterior Cervical Fusion Navigated Instruments are intended to be used with the EUROPA™ Posterior Cervical Fusion System screws. The EUROPA™ Posterior Cervical Fusion Navigated Instruments consist of non-sterile, re-usable instruments including probes, drivers, awls, drills, and taps that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System and are manufactured from Stainless Steel per ASTM F899.

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VB Spine Q Pedicle Instruments are intended to be used as accessories to Stryker's Spine Guidance System to facilitate placement of VB Spine implants. They can be navigated instruments or non-navigated manual instruments. When navigated, VB Spine Q Pedicle Instruments are specifically designed for use with the Spine Guidance Software. They are intended to be used with a Q Navigation Adaptor and associated trackers manually or under power with a Stryker Rotary Handpiece to facilitate pedicle preparation and placement of VB Spine implants in the non-cervical spine in adult and pediatric (adolescent) patients in accordance with the indications and contraindications of the associated VB Spine Implant System and/or Stryker's Spine Guidance System.

The Q Pedicle Instruments include Q Taps and Q Screwdrivers. The Q Pedicle Instruments are intended to be used to facilitate pedicle preparation and screw placement of VB Spine implants.

These instruments are designed to be compatible with Stryker's Spine Guidance 5 Software and Mako Spine System.

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The Stealth AXiS™ Surgical System, with the Stealth AXiS™ ENT clinical application, is intended for precise positioning of surgical instruments and as an aid for locating anatomical structures in open, minimally invasive, and percutaneous ENT procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.

This can include, but is not limited to, the following procedures:

• Functional endoscopic sinus surgery (FESS)
• Endoscopic skull base procedures
• Lateral skull base procedures

The Stealth AXiS ENT Clinical Application works in conjunction with the Stealth AXiS Surgical System, which consists of clinical software, surgical instruments, a referencing system, and platform/computer hardware. The Stealth AXiS™ ENT Clinical Application helps guide surgeons during ENT procedures such as functional endoscopic sinus surgery (FESS), endoscopic skull base procedures, and lateral skull base procedures. The system tracks the position of instruments in relation to the surgical anatomy, known as localization, and then identifies this position on preoperative or intraoperative images of a patient.

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TMINI® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.

The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools.

The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System. The TMINI® Miniature Robotic System is compatible with and to be used with the following knee replacement systems in accordance with the indications and contraindications:

• Enovis™ EMPOWR Knee System®
• Ortho Development® BKS® and BKS TriMax® Knee System
• Total Joint Orthopedics Klassic® Knee System
• United® U2™ Total Knee System
• Medacta® GMK® Sphere / SpheriKA Knee Systems
• Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
• b-ONE MOBIO® Total Knee System
• Maxx Orthopedics Freedom® Total & Titan Knee
• LINK® LinkSymphoKnee System
• Stryker® Triathlon® Knee System

The TMINI® Miniature Robotic System (TMINI 1.2) like its predicate, the TMINI® Miniature Robotic System consists of three primary components: a three-dimensional, graphical, Preoperative Planning Workstation with the TCM web based plan review, approval and download component, an Optical Tracking Navigation Console (TNav) and a robotically controlled hand-held tool (TMINI Robot) that assists the surgeon in preparing the bone for implantation of TKA components. This has not changed as a result of the modifications to the software associated with this submission.

In the both the TMINI 1.2 and the predicate the TPLAN Planning Station uses preoperative CT scans of the operative leg to create 3D surface models for case templating and intraoperative registration purposes. The Planning Workstation contains a library of 510(k) cleared knee replacement implant(s) available for use with the system. The surgeon can select an implant model from this library. The planner/surgeon can manipulate the 3D representation of the implant in relation to the bone model to optimally place the implant. The surgeon reviews and approves the case plan using either TPLAN or the TCM web-based application once the surgeon is satisfied with the implant selection, location and orientation. The data from the approved plan is written to a file that is used to guide the robotically controlled hand-held tool.

In the both the TMINI 1.2 and the predicate the hand-held robotic tool is optically tracked relative to optical markers placed in both the femur and tibia and articulates in two degrees-of-freedom, allowing the user to place bone pins in a planar manner in both bones. Mechanical guides are clamped to the bone pins, resulting in subsequent placement of cut slots and drill guide holes such H that the distal femoral and proximal tibial cuts can be made in the pre-planned positions and orientations, and such that the implant manufacturer's multi-planer cutting block can be placed relative to drilled distal femoral pilot holes. If the surgeon needs to change the plan during surgery, it can be changed intraoperatively.

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The Mako System is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Mako System is indicated for use in surgical total knee procedures in which the use of stereotactic surgery may be appropriate and where reference to rigid anatomical bony structures can be identified relative to a CT-based model of the anatomy. These procedures include:

• Total Knee Arthroplasty (TKA)

The implant systems compatible with the system:

• Triathlon Total Knee System (CR/CS/PS/PSR/MS cemented and cementless primary)
• Triathlon Total Knee System (TS inserts, cemented primary)

The Mako System with the subject Mako Total Knee Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, a camera, a computer, dedicated instrumentation, an operating software, and tools and accessories.

The system's architecture is designed to support total and partial knee procedures and total hip procedures. With application specific hardware and software, the system provides haptic guidance during orthopedic surgical procedures by using patient CT data to assist a surgeon with pre-surgical planning, implant placement, and interpretive/intraoperative navigation of the patient's anatomy.

Once configured for a specific application, the Mako robotic arm can serve as the surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.

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