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The Fluorotactic Guidance System Mk. I will be used to assist in the accurate placement of a guiding device for surgery in which a linear trajectory insertion or placement is required. This system will use coordinated-fluoroscopy to allow intra-operative planning of the precise insertion point and angle of a device such as a screw, nail, or needle.

The surgeon will place a registration artifact over the desired surgical area and capture two fluoroscopic images, which will then be displayed on two computer screens. The surgeon will manipulate a virtual guidewire on the screens, until the desired angle and placement is achieved. The system will then output 3D coordinates to the robot arm which will move the drill guide to a precise position.

The Fluorotactic Guidance System Mk. I is an integrated system that enables a surgeon to more accurately position drill guides, screw drivers, needles, and other surgical instruments using two captured fluoroscopic images. An electromechanical arm is used to accurately position an end-effector over the desired surgical area, and two approximately orthogonal images are captured with a standard flouroscope. The two images are displayed on computer monitors and used to perform accurate intra-operative planning. The plan consists of specifying the instrument entry point, and sagittal and transverse orientations. The system will then calculate the necessary coordinates for the robot ann, which will position the drill guide over the surgical area.

The Fluorotactic Guidance System Mk. I system will consist of four components:

1. Robot arm
2. Registration/drill guide artifact
3. Fluoroscopic image intensifier system (C-arm)
4. Personal computer (PC) with a Data Translation image acquisition card and two monitors

The robot arm will hold a registration artifact which is transparent to X-rays over the patient in proximity to the desired surgical area. This artifact has eight steel balls embedded such that when the C-arm is used to capture images of the area, the balls will create fiducial shadows on the image. Two images will be required, an Anterior/Posterior (A/P) view and a Sagittal view.

The PC will receive the image data from the C-Arm and display it on two monitors. The surgeon will indicate the desired positioning of the drill by manipulating a virtual guidewire on the screens. The software will then use the fiducial location information to calculate the coordinates for the positioning of the drill guide, and the robot arm will move to the new orientation.

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) summary for the Z-KAT Fluorotactic Guidance System Mk. I, which focuses on demonstrating substantial equivalence to predicate devices rather than reporting the results of a specific performance study against pre-defined acceptance criteria.

However, based on the description of the device and its intended use, we can infer the types of performance criteria that would be relevant for such a system. The core function is the "accurate placement" of surgical instruments using "coordinated-fluoroscopy" and a "robot arm" to achieve a "precise position." Therefore accuracy would be the primary metric.

Here's a hypothetical structure of the requested information, acknowledging that the specific values and study details are not present in the provided text and would need to be synthesized or assumed for a complete answer.

Inferred Acceptance Criteria and Hypothetical Performance Study (Based on device description)

Given that the Z-KAT Fluorotactic Guidance System Mk. I is designed to assist in the "accurate placement of a guiding device for surgery," the primary acceptance criterion would relate to the accuracy of instrument positioning.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: (Hypothetical) 50 simulated surgical scenarios involving phantom models.
• Data Provenance: (Hypothetical) Prospective study conducted in a laboratory setting, using standardized phantom models designed to mimic human anatomy (e.g., bone structures for drill guide placement). The phantoms would be representative of various surgical sites where the device might be used (e.g., spinal, orthopedic).

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

• Number of Experts: (Hypothetical) 3
• Qualifications of Experts: (Hypothetical) Board-certified orthopedic surgeons or neurosurgeons, each with at least 15 years of experience in image-guided surgery techniques and familiar with stereotactic principles. They would be involved in defining the "desired" or "true" surgical trajectory on the phantom models.

4. Adjudication Method for the Test Set

• Adjudication Method: (Hypothetical) Expert Consensus (None in the typical 2+1, 3+1 sense as it's a technical accuracy study). In this type of technical accuracy study, the "ground truth" for the desired trajectory is established a priori by the engineering team and validated by the expert surgeons. The deviation of the device's output (robot arm position) from this pre-defined ground truth is directly measured. If there were discrepancies in how the "desired trajectory" was established by experts, a consensus meeting would be used to reconcile differences.

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

• MRMC Study: (Hypothetical) No, not explicitly stated or implied for this submission. The FDA 510(k) summary focuses on the technical capability and safety of the device itself, comparing it to predicate devices. A MRMC study would typically evaluate the impact of the human-in-the-loop performance (i.e., how surgeons using the system perform compared to surgeons without it), which is usually beyond the scope of an initial 510(k) for a guidance system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: (Hypothetical) Yes, the described accuracy metrics (Linear and Angular Trajectory Placement Accuracy) would represent the standalone performance of the system. The device's ability to precisely position the robot arm based on the surgeon's virtual guidewire manipulation and the system's independent calculation would be measured. The human input (surgeon moving the virtual guidewire) is an input to the system, but the output (robot arm position) is a function of the system's accuracy in executing that input based on image processing and robotic control.

7. The Type of Ground Truth Used

• Ground Truth Type: (Hypothetical) Precision-machined phantom models with known fiducial marker locations and predefined target trajectories. The "true" or "desired" trajectory would be engineered into the phantom with high precision, allowing for direct measurement of the deviation of the system's placement from this known truth.

8. The Sample Size for the Training Set

• Training Set Sample Size: (Hypothetical) The document does not describe AI/machine learning components that would typically require a training set for its core guidance function (image registration, robot control). If the system did employ such components (e.g., for automated anatomical landmark recognition), the training set size would be: Not Applicable (or not specified for this device's core functionality as described). If there were internal software models (e.g., for optimal C-arm placement, or image enhancements), those might have been developed using various fluoroscopic images, but this isn't explicitly mentioned for a "training set" of a machine learning model.

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

• Ground Truth for Training Set: (Hypothetical) Not Applicable, as no explicit machine learning training set is described for the core guidance function. If AI/ML components were later introduced, ground truth would likely be established through:
  • Manual annotation by multiple experts: Experts would delineate structures, identify landmarks, or classify image features on a large dataset of fluoroscopic images.
  • Consensus from multiple (e.g., 3-5) highly experienced radiologists/surgeons, followed by majority vote or arbitration in cases of disagreement.
  • Pathology or high-resolution imaging correspondence for anatomical landmark ground truth.

Disclaimer: The information in this response beyond what is directly stated in the provided 510(k) summary is hypothetical and based on common practices for evaluating medical guidance systems. The actual acceptance criteria and study details would be specific to Z-KAT's internal design validation and verification processes.

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