Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI by Z-KAT, INC.

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.

Device Description

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:

Robot arm
Registration/drill guide artifact
Fluoroscopic image intensifier system (C-arm)
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.

AI/ML Overview

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

Acceptance Criteria	Value (Hypothetical)	Reported Device Performance (Hypothetical)	Meets Criteria? (Hypothetical)
Linear Trajectory Placement Accuracy	≤ 1.0 mm	Mean error: 0.75 mm (95% CI: 0.60-0.90 mm)	Yes
Angular Trajectory Placement Accuracy	≤ 1.0 degree	Mean error: 0.8 degrees (95% CI: 0.65-0.95 degrees)	Yes
System Set-up Time	≤ 10 minutes	Mean time: 8 minutes	Yes
Image Acquisition Latency	< 1 second	Average latency: 0.2 seconds	Yes
Software Response Time (Guidewire manipulation to robot arm movement)	< 1 second	Average response: 0.5 seconds	Yes

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.

Summary

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JUN 2 3 1999

K984298

11645 Biscayne Blvd. Suite 308 Miami, FL 33181-3139 Tel 305.895.9022 Fax 305.895.8286 zkat@z-kat.com

510(k) Summary

Submitter: Z-KAT, Inc.

Address: 11645 Biscayne Blvd. Suite 304 Miami, FL 33181

Phone number: (305) 895-9022

Fax number: (305) 895-9023

Contact person: Rony Abovitz

Date prepared: November 18, 1998

Trade name: Z-KAT Fluorotactic ™ Guidance System

Common name: Stereotaxic Instrument

Classification name: Class II

Substantial equivalence claimed to:

1. StealthStation, Surgical Navigation Technologies, Inc., K954276
1. Radionics Operating Arm & OTS System/StereoPlan, K961844
1. Picker International Viewpoint System, K970604
1. Fischer Imaging AutoGuide (Part of Mammotest Mammography System), K861692

Description:

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Summary of technological characteristics:

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

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

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three stripes extending from its back, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 1999

Mr. Rony Abovitz Mr. Rony Aboviz
Vice President, Biomedical Research and Development Z-KAT, Inc. 11645 Biscayne Boulevard, Suite 304 Miami, Florida 33181

K984298 Re: K984298
Trade Name: Z-KAT Fluorotactic™ Guidance System Regulatory Class: II Product Code: HAW Dated: March 30, 1999 Received: March 31, 1999

Dear Mr. Abovitz:

We have reviewed your Section 510(k) notification of intent to market the device referenced
in the indication in the best in the increases tiglizent (for the indications for We have reviewed your Securit is tu(K) notified to wivalent (for the indications for
above and we have determined the device is substantially equivalent (for the indications above and we have determined the devices marketed in interstate commerce prior to the use stated in the enclosure) to devices marketed be simments, or to devices that
May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that May 28, 1976, the enactment date of the Messions of the Federal Food, Drug, and
have been reclassified in accordance with the provisions of the Federal Food, Drug, and have been reclassified in accordance with the provisions of the general controls
Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosmetic Act (Act). You may, therelore, inaractions of the Act include requirements for provisions of the Act. The general connolo provincial in the more of actice, labeling, and annual 10gistrations against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III
nd in the same of the collection of the diditional controls. Existing major If your device is classified (see above) into such additions controls. Existing major (Premarket Approval), it may be subject to such addition of Federal Regulations, Title 21,
regulations affecting your device can be found in the commencembiance with the regulations aftecting your device can be tound in the occase assumes compliance with the Parts 800 to 895. A substantially equivalia as set forth in the Quality System
current Good Manufacturing Practice requirement, as set forth in the Part 870) and the current Good Manufacturing Fractice requiation (21 CFR Part 820) and that,
Regulation (QS) for Medical Devices: General Instituction (EDA) will verif Regulation (QS) for Medical Devices. General IDBut Administration (FDA) will verify
through periodic (QS) inspections, the AM samation may result in regulatory through periodic (QS) Inspections, the I ook and Drag Presult in regulation may result in regulatory such assumptions. Failure to comply with in Girli regencents concerning your device in the action. In addition, FDA may publish nuture announcemarket notification submission does
Federal Register. Please note: this response to your premarket notification in the A Federal Register. Please note: tills response to Jour pros. 53 through 542 of the Act for not affect any obligation you might have under socked by on other Federal laws or regulations.

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Page 2 -- Mr. Rony Abovitz

This letter will allow you to begin marketing your device as described in your 510(k) This letter will anow you to begin mainer of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of and additionally 6097794-4595. Additionally, for questions on the promotion and Compliance at (201) 591 1595. Financially , 1997. Inchience at (301) 594-4639 Also, please note the regulation entitled, "Misbranding by reference to premarket Also, prease note the regulation only see are al information on your responsibilities under the notification (21 CFTC 007.97). Only getting of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

a M. Witten, Ph.D., M.D Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K984298 510(k) Number (if known):_

Device Name: Z-KAT Fluorotactic ™ Guidance System Mk. I

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K984298
Prescription Use(Per 21 CFR 801.109)	X
	OR
	Over-the-Counter Use

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).