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The PathKeeper System is a stereotaxic image guidance system intended for the spationing and orientation of surgical instruments used by orthopedic surgeons and neurosurgeons during posterior approach spinal fusion surgeries when pre-operative CT imagery is available. The System, with PathKeeper spine surgery planning and navigation software and 3D optical camera, is intended as an aid for precisely locating anatomical structures in posterior approach open spine fusion surgery during pedicle screw placement in the thoraco-lumbo-sacral region.

The device is indicated for posterior approach open spine fusion surgery during pedicle screw placement in the thoracolumbo-sacral region where reference to a rigid anatomical structure can be identified.

The PathKeeper System is an Orthopedic Surgical Navigation System. The system provides registration between preoperative computed tomography (CT) data and intraoperative Optical Topographic Image (OTI) data acquired using a proprietary OTI 3D camera. The system provides surgical guidance data by displaying the location of optically tracked Surgical Accessories relative to the patient anatomy, based on the calculated registration. Position and orientation data of PathKeeper's Tracked Surgical Accessories are linked to the preoperative scan data using the workstation.

The PathKeeper System is designed for open spine surgery where reference to a rigid structure - Dynamic Reference Frame (DRF) - spine reference DRF - can be identified relative to the pre-operative image data of the anatomy. In open spine surgery the posterior elements of the operated vertebrae are exposed, either unilaterally or bilaterally. PathKeeper System's 3D image-processing capabilities provide co-registration of the topography of exposed bone structures obtained by the proprietary OTI 3D camera, to the pre-operative CT scan of the patient.

The PathKeeper System is a portable console.

The components of the PathKeeper System are, in arbitrary order:

• . Workstation Cart with Articulated Arm ALSO referred to as Cart with Head (articulated arm and Camera) - A high-resolution proprietary Camera with OTI capabilities mounted to an articulated rigid metallic holding arm, computer (with PathKeeper software installed), monitor, keyboard, mouse, and DVD drive on a medicalgrade cart. The cart with its parts described above, is provided nonsterile with cleaning instructions in the User Manual. There is no patient contact.
• . PathKeeper Software for pre-operative planning and intra-operative registration and navigation. The PathKeeper Software shall be installed on the workstation computer and displayed on the workstation monitor and will perform the bulk of the required computation for the system to operate. There is no patient contact.
• . Surgical Accessories Kit including the following components:
  • · 6 Navigation Dynamic Reference Frames (DRFs) which are to be attached to common surgical tools (i.e., Awl, Pedicle probe, and Screwdriver). Note: Tools are not provided with the system and are not subject to this submission
  • Tool setun/calibration plate DRF
  • · Spine reference DRF
• · Sterilization case (all DRFs above reside in this case)
  These tools are reusable, steam-sterilized accessories serving as spatial markers.
• . Spheres - Single-use sterile standard navigation Retro-Reflective Spheres. Note: these are acquired off-the-shelf items and not provided with the system or the subject of this submission.
• . Patient reference attachment mechanism - off-the-shelf attachment mechanism (Walton Cartilage Clamp, 8", Curved, Catalog # 270-170, manufactured by Integra LifeSciences) via which the Spine reference DRF (patient reference) is connected to the bony anatomy of the spine. Note: this is an acquired off-the-shelf item and not provided with the system or the subject of this submission.
• . Sterile cover for handle - off-the-shelf single-use sterile cover (Universal Surgical Light Handle Cover, Catalog # LB82, manufactured by Steris Corporation) same as for OR lighting handles. Note: this is an off-the-shelf item and not provided with the system or the subject of this submission.

Here's an analysis of the acceptance criteria and study information for the PathKeeper System, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance for PathKeeper System (K222355)

The provided document describes the non-clinical performance data used to demonstrate the safety and effectiveness of the PathKeeper System.

1. Table of Acceptance Criteria and Reported Device Performance

The summary doesn't explicitly list numerical "acceptance criteria" alongside "reported device performance." Instead, it states that "All accuracy specification were met" following various tests. The key performance metric highlighted is accuracy, assessed against ASTM F2554-18 and Target Registration Error.

While specific numerical targets for acceptance criteria are not detailed in this summary, the conclusions of the verification and validation activities serve as implicit statements of meeting acceptance criteria.

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

The primary test sets mentioned for accuracy assessment are:

• Phantom Models: Used for testing against ASTM F2554-18 and Target Error Registration. No specific sample size for phantom models is provided.
• Human Cadaveric Workflow Study: Performed for usability testing. No specific sample size for cadavers is provided.
• Non-Clinical Human Cadaver Performance Testing: Used for accuracy assessment. No specific sample size for cadavers is provided.

The data provenance is non-clinical, involving phantom models and human cadavers. This indicates that the data is not from live patients, and therefore, there is no country of origin of patient data or distinction between retrospective or prospective in the clinical sense.

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

The document mentions "Surgeon Performed Human Cadaveric Workflow Study - from usability testing" and "Non-Clinical Human Cadaver Performance Testing." However, it does not specify the number of experts used to establish ground truth or their qualifications. It implicitly refers to "surgeons" in the context of usability and performance testing on cadavers, suggesting their involvement in these evaluations.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth on the test sets. The accuracy assessments are stated to be based on comparisons to "ground truth position (on phantom)" but the process for determining this ground truth is not detailed beyond adhering to ASTM F2554-18.

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

No MRMC comparative effectiveness study was done or reported in this 510(k) summary. The study focuses on the standalone performance of the device in non-clinical settings. There is no mention of human readers improving with AI assistance because the PathKeeper System is a navigation system, not an AI-assisted diagnostic tool that interprets images for human readers.

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

Yes, a standalone performance study was done. The non-clinical performance data, particularly the accuracy tests on phantom models and cadavers (against ASTM F2554-18 and Target Error Registration), evaluate the device's ability to precisely locate anatomical structures and guide surgical instruments without an explicit "human-in-the-loop" evaluative step for its accuracy claims. The system itself provides the navigational data and the accuracy assessment verifies this data against a known truth.

7. Type of Ground Truth Used

The ground truth used for accuracy assessment was primarily established through physical measurements and known positions on phantom models, validated against a standard (ASTM F2554-18), and "ground truth position (on phantom)". For cadaveric studies, the ground truth would typically involve physical measurements or verified anatomical landmarks to assess the accuracy of the system's tracking and navigation. There is no mention of pathology or outcomes data as ground truth, as these are typically associated with clinical studies or diagnostic devices.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set of the PathKeeper System's software or algorithms. Device training sets are typically internal developmental data and are not usually disclosed in 510(k) summaries unless specifically relevant to novel AI/ML aspects requiring specific FDA review.

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

Similarly, the document does not specify how the ground truth for the training set was established. This information is generally part of the internal development process and not typically included in a 510(k) summary unless explicitly requested or critical for demonstrating substantial equivalence for an AI/ML device.

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