The Lorenz Fiducial Screw is intended for establishing fixed reference point(s) in patients requiring stereotactic surgery. The Fiducial Screw can be used as an accessory with frameless navigation systems, as appropriate, from other manufacturers.

Device Description

The Lorenz Fiducial Screw is a self drilling metallic fixation device with a stop used only as a reference point during stereotactic procedures.

AI/ML Overview

This document is a 510(k) summary for the Lorenz Fiducial Screw, a medical device. It does not contain information about acceptance criteria or a study proving device performance in the way typically seen for diagnostic or AI-powered devices.

The document indicates that the device's substantial equivalence was established by comparing it to predicate devices already on the market (Howmedica Leibinger, Inc. Ost-Reg Marker System for Stereotaxic Navigation, K961120 and Lorenz 1.0mm, 1.5mm, 2.0mm systems, K953385). This means that the device is considered safe and effective because it is substantially similar to devices that have already been cleared by the FDA.

Therefore, many of the requested elements (like a table of acceptance criteria and reported device performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

Here's how to address the request based on the provided text:

1. A table of acceptance criteria and the reported device performance

Not applicable. This 510(k) submission relies on substantial equivalence to predicate devices rather than demonstrating performance against specific acceptance criteria through a novel study. The "performance" is implicitly tied to the established safety and effectiveness of the predicate devices for their stated intended uses.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No new test set data was generated for a performance study. Substantial equivalence is based on comparing the new device's design, materials, and intended use to existing, cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment by experts for a test set was performed as part of this substantial equivalence submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not a diagnostic or AI-powered device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (fiducial screw), not an algorithm or AI system.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" equivalent in a 510(k) for a simple device like this is the established safety and effectiveness profile of the predicate devices.

8. The sample size for the training set

Not applicable. No training set was used as this is a physical device, not a machine learning model.

9. How the ground truth for the training set was established

Not applicable. No training set or associated ground truth establishment was performed.

Summary of the Document's Approach to Demonstrating Safety and Effectiveness:

The document establishes the safety and effectiveness of the Lorenz Fiducial Screw through substantial equivalence to predicate devices. This means the device is considered safe and effective because it shares the same intended use and similar technological characteristics (design, materials, etc.) as devices already legally marketed. The submission does not involve new clinical performance studies or the establishment of specific acceptance criteria against empirical data for its clearance.

Summary

{0}------------------------------------------------

MAR 1 5 2001

Summary of Safety and Effectiveness

Device Name:	Lorenz Fiducial Screw
Classification Name:	Stereotaxic Instrument and Accessory
Device Product Code:	Neurology: 84HAW (21 CFR 882.4560)

Intended Use:

Description:

The Lorenz Fiducial Screw is a self drilling metallic fixation device with a stop used only as a reference point during stereotactic procedures.

Sterility Information:

The Fiducial screw will be marketed as non-sterile, single use devices. Steam Sterilization recommendations are included in the package insert and can be seen in Attachment I.

Substantial Equivalence:

Walter Lorenz considers the Lorenz Fiducial Screw equivalent to the Howmedica Leibinger, Inc. Ost-Reg Marker System for Stereotaxic Navigation, K961120 and Lorenz 1.0mm, 1.5mm, 2.0mm systems, K953385. TAB 3 includes a substantial equivalence comparison table to competitive devices. TAB 4 includes information for Howmedica Leibinger, Inc.

Possible risks:

Lorenz Fiducial Screws should not be used when there is the following:

1. Bone infection
1. Skin infection

000011

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2001

Ms. Kim Reed Regulatory Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, Florida 32218

K010427 Re: Trade Name: Lorenz Fiducial Screw Regulatory Class: II Product Code: HAW Dated: February 6, 2001 Received: February 13, 2001

Dear Ms. Reed:

We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 510(x) notificantalially equivalent (for the indications for above and we have determined this as marketed in interstate commerce prior to use stated in the enclosure) to devices manological Device Amendments, or to devices that May 28, 1970, the ellacinem date of the Frederal Food, Drug, and have been reclassified in accordance with the pro research, subject to the general controls Cosmetic Act (Act). You may, therefore, manor ano of the Act include requirements for
es and provisions of the Act. "The general connects pood 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 (Premarket Approval), it may be subject to such additional controls. Existing major (Premarket Approval), it may be subject to satis as a federal Regulations, Title 21, regulations arrecting your device can of roans in the mination assumes compliance with the Parts 600 to 695. A Substantially Squarement, as set forth in the Quality System current Good Manufacturing Practice requiation (21 CFR Part 820) and that, Regulation (QS) for Medical Devices: Sood and Drug Administration (FDA) will verify
through periodic (QS) inspections, the Food and Drug Administration within result to through periodic (Q3) inspections, the I 000 and in regulation may result in regulations such assumptions. Tanufe to comply with the SHE cognification whenice in the action. In addition. PDA may publish farmer and continued on the first on submission does Federal Register. Prease note: this response to Jour pross 31 through 542 of the Act for not allect any obligation you might have and control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

Page 2 - Ms. Kim Reed

This letter will allow you to begin marketing your device as described in your 510(k) This letter will anow your even finding of substantial equivalence of your device to a premarket notification. THE PDT Intellige or calassification 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 If you desire specific as for in vitro diagnostic devices), please contact the Office of and additionally 009:104-4595. Additionally, for questions on the promotion and Compliance at (301) 591 1595. Practition of Compliance at (301) 594-4639. advertising of your avrievy from entitled, "Misbranding by reference to premarket Also, prease note the regulation online and information on your responsibilities under the nother (21 OF IC 801197). States 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,

for

Miriam. C. Provost

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

{3}------------------------------------------------

STATEMENT OF INDICATIONS FOR USE

510(k) Number: K010 427

Device Name: Lorenz Fiducial Screw

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)		OR	Over-The-Counter-Use(Optional Format 1-2-96)
------------------------------------------	--	----	--------------------------------------------------

Miriam C. Provost

(Division Sign-Off)

Division of General, Restorative

and Neurological Devices

510(k) Number	K010427
---------------	---------

000001

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).