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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 The Fluorotactic Guidance System Mik. I is all mice states, and other surgical instruments using two captured fluoroscopic images. An electromechanical arm is used to instruments using two captured indoroscopic mages. The capacity of the 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 The plan consists of specifying the misulate the necessary coordinates for the robot arm, 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. Pludical 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 entibediced 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 suidewire 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.

This 510(k) summary (K984298) describes the Z-KAT Fluorotactic™ Guidance System Mk. I, a stereotaxic instrument intended to assist in the accurate placement of a guiding device for surgery using coordinated fluoroscopy. However, it does not provide details about specific acceptance criteria or a study proving the device meets accepted performance standards.

Here's an analysis based on the provided text, highlighting what is missing or explicitly not stated:

1. Table of Acceptance Criteria and Reported Device Performance

Comments: The submission describes the functionality of the device (enabling a surgeon to guide instruments using two captured fluoroscopic images, calculating coordinates for a robot arm), but does not specify quantifiable acceptance criteria (e.g., "positioning accuracy within X mm") nor does it present data showing the device achieved such criteria. The purpose of this 510(k) is to demonstrate substantial equivalence to previously cleared devices, not necessarily to prove specific performance metrics against pre-defined acceptance criteria with a new, standalone study.

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

• Test Set Size: Not specified.
• Data Provenance: Not specified. (The document mentions using a standard C-arm to capture images but doesn't detail any clinical or simulated test data used for performance evaluation in this summary.)

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

• Adjudication Method: Not specified.

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

• MRMC Study Done: No, this document does not describe an MRMC comparative effectiveness study.
• Effect Size of AI vs. Without AI: Not applicable, as no such study is presented. The device is a guidance system, not an AI for interpretation.

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

• Standalone Study Done: Not explicitly described. The summary focuses on the integrated system where the surgeon manipulates a virtual guidewire and the system outputs coordinates for the robot arm. While the software performs calculations independently, a "standalone study" in the context of device performance usually implies direct quantitative measurement of the algorithm's output against a gold standard without human input as part of the measured performance metric. This is not detailed.

7. Type of Ground Truth Used

• Type of Ground Truth: Not specified. For a guidance system, ground truth would typically involve precise measurements (e.g., from a phantom or cadaver with known fiducial locations) to assess accuracy between the intended and actual positions. This is not mentioned.

8. Sample Size for the Training Set

• Training Set Size: Not applicable/Not specified. This device is described as a guidance system that performs calculations based on image input and surgeon interaction. It's not presented as a machine learning or AI model that requires a "training set" in the conventional sense to learn patterns from data.

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

• Ground Truth Establishment for Training Set: Not applicable/Not specified, as it's not described as an AI/ML model needing a training set.

In summary, this 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use. It does not contain the detailed performance study information, acceptance criteria, or ground truth methodology that would typically be found in a more comprehensive premarket approval (PMA) application or a 510(k) for a novel AI/ML-driven device requiring extensive clinical validation. The FDA's clearance (K984298) acknowledges the device's substantial equivalence for the stated indications for use, implying that the safety and effectiveness are comparable to existing, legally marketed predicate devices without necessarily requiring new, extensive performance data against predefined acceptance criteria for this specific submission type.

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