FluoroLab Plus will be used for navigational guidance to position instruments during surgical procedures. It will provide a method of navigational guidance of tools through the use of a standard C-arm fluoroscope to capture images and an optical camera for instrument tracking. This increase in control will free the surgeon from the iterative process conventionally used, reduce the length of the surgical procedure, and enable minimally invasive procedure. In addition, since only two fluoroscopic images are needed, the exposure to X-rays is greatly reduced.

FluoroLab Plus will be used to assist in the alignment of surgical instruments by providing the surgeon with intraoperative navigational guidance based on pre-acquired fluoroscopic images. Surgeon will use coordinated-fluoroscopy to allow intra-operative planning of the alignment of surgical tools such as a screw, nail, or needle.

Device Description

FluoroLab Plus is an integrated system that helps a surgeon more accurately position drill guides, screw drivers, needles, and other surgical instruments using at least two captured fluoroscopic images. The acquired images are displayed on a flat panel monitor. Surgical tools and accessories are instrumented with LEDs or small reflective markers. Their positions and orientations are continuously tracked by an optical camera and updated in reference to the fluoroscopic images to provide constant navigational guidance to the target.

FluoroLab Plus will consist of following basic components:

Registration phantom
Calibration grid
Fluoroscopic image intensifier system (C-arm)
Computer workstation with monitor and video acquisition box
Ergonomic cart
FluoroLab Plus software application
Optical camera with Tool Interface Unit (TIU)
Tools and accessories surgical tools and accessories instrumented with LEDs or reflective markers

AI/ML Overview

The provided 510(k) summary for the FluoroLab Plus device does not include explicit acceptance criteria, a detailed study report proving the device meets acceptance criteria, or information on human reader performance with or without AI assistance. The document is primarily a premarket notification for substantial equivalence.

However, based on the information provided, we can infer some details related to the device's characteristics and the submission process.

Here's an analysis based on the given text, noting when information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria (e.g., accuracy thresholds, precision targets, recall/precision metrics). Nor does it contain a table summarizing these criteria against reported performance data from a specific study. The submission focuses on substantial equivalence to predicate devices rather than presenting detailed performance validation against explicit criteria.

The "DESCRIPTION" and "SUMMARY OF TECHNOLOGICAL CHARACTERISTICS" sections describe what the device does and what it consists of, but not quantitative performance criteria it must meet. The "Intended Use" section outlines the functional benefits (e.g., "more accurately position drill guides," "reduce the length of the surgical procedure," "greatly reduced [exposure to X-rays]"), but these are not quantified as acceptance criteria.

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

The document does not mention a test set sample size or detail the provenance of any data used for testing. The submission is a 510(k) for substantial equivalence, which often relies on comparison to existing legally marketed devices rather than extensive new clinical trial data, especially for Class II devices like this stereotaxic instrument.

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

The document does not describe any expert-established ground truth or the number and qualifications of experts involved, as it does not detail a specific performance study or test set validation.

4. Adjudication Method for the Test Set

Since no specific test set or expert ground truth establishment is described, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

The device, FluoroLab Plus, is described as an "integrated system that helps a surgeon more accurately position drill guides, screw drivers, needles, and other surgical instruments." While it offers "navigational guidance," it is a tool for a surgeon, not an AI-powered diagnostic or assistive tool in the modern sense of "AI" (e.g., machine learning for image interpretation). Therefore, an MRMC study comparing human readers with and without "AI assistance" in the context of diagnostic interpretation is not applicable and not mentioned. The device augments a surgeon's ability to navigate tools, rather than enhancing human "reading" of images.

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

The device is inherently designed for "human-in-the-loop" performance, as it provides "navigational guidance" to a surgeon. It's not a standalone diagnostic algorithm. Therefore, a standalone (algorithm-only) performance study is not discussed and not applicable in the context of this device's function.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not specify any type of ground truth used for performance evaluation, as it does not detail a specific performance study. Given the device's function (navigational guidance for instrument placement), ground truth would likely relate to the accuracy of tool placement relative to a target, based on physical measurements or imaging verification rather than expert consensus on a diagnosis, pathology, or outcomes data. However, no such study is presented.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This type of stereotaxic instrument, predating widespread use of deep learning AI, would typically be developed through engineering and calibration, not through training on a large dataset in the way a modern AI algorithm would be.

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

As no training set is described for an AI/ML context, there is no information on how ground truth for a training set was established. The "ground truth" for the device's functionality would be established through engineering specifications, calibration procedures, and accuracy testing in a controlled environment.

Summary

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K0/3025

Image /page/0/Picture/1 description: The image shows the logo for "z-kat, inc.". The logo features a stylized letter "z" on the left side of the text. The text is in a simple, sans-serif font and is horizontally aligned.

OCT - 3 2001

2905 simms street hollywood florida 33020 tel 954.927.2044

fax 954 927 0446

zkatīzz-kat.com www.z.kat.com

510(K) SUMMARY

SUBMITTER: Z-KAT, Inc.

ADDRESS: 2903 Simms Street

Hollywood, FL 33020

PHONE NUMBER: 954-927-2044

FAX NUMBER: 954-927-0446

CONTACT PERSON: William F. Tapia

DATE PREPARED: August 23, 2001

TRADE NAME: FluoroLab Plus

COMMON NAME: Stereotaxic Instrument

CLASSIFICATION NAME: Class II

SUBSTANTIAL EQUIVALENCE CLAIMED TO:

The Fluorotactic Guidance System, Mk I, Z-KAT, Inc., K984298 1.
1. StealthStation, Sofamor Danek, K954276
1. FluoroNav, Sofamor Danek, K990214
1. The Voyager; Marconi Medical Systems, K000310
1. VectorVision2, BrainLab, K962939

DESCRIPTION:

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

FluoroLab Plus will consist of following basic components:

1. Registration phantom

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1. Calibration grid
1. Fluoroscopic image intensifier system (C-arm)
1. Computer workstation with monitor and video acquisition box
1. Ergonomic cart
FluoroLab Plus software application 6)
Optical camera with Tool Interface Unit (TIU) 7)
Tools and accessories surgical tools and accessories instrumented with LEDs or reflective 8) markers

INTENDED USE:

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 3 2001

William F. Tapia Z-KAT, Inc. 2903 Simms Street Hollywood, Florida 33020

Re: K013025

Trade/Device Name: FluoroLab Plus Regulation Number: 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: August 23, 2001 Received: September 10, 2001

Dear Mr. Tapia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. William F. Tapia

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Walker, MS

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

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2903 simms street hollywood florida 33020 tel 954.927.2044 fax 954 927 0446

INDICATIONS FOR USE

510(k) Number (if known):	K013025
---------------------------	---------

Device Name: FluoroLab Plus

Indications for Use:

FluoroLab Plus will be used to assist in the alignment of surgical instruments by providing the surgeon with intraoperative navigational guidance based on pre-acquired fluoroscopic images.
Surgeon with intraoperative navigational guidance based on pre-acquired fluorosco Surgeon will use coordinated-fluoroscopy to allow intra-operative planning of the alignment of surgical tools such as a screw, nail, or needle.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-the-Counter Use

(Per 21 CFR 801.109)

Su Wor

(Division Sign-Off) (Division of General, Restorative and Neurological Devices

510(k) Number K013025

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).