The Halm Zielke Instrumentation System is an anterior spinal fixation system indicated for spinal deformities in the thoracic and lumbar spine such as scoliosis, kyphosis, lordosis and thoracolumbar spinal instability caused by fracture.

Device Description

The principal components of the Micomed Halm Zielke Instrumentation System, which is a low profile spinal fixation system, are as follows: Halm and HC plates, screws, threaded rods, standard hex nuts for threaded rods, fluted rods, and vertebral clamps (double and single hole). Additional instrumentation includes: awls, wrenches, insertion instruments for rods and screws, vertebral and end vertebra screws, top loading screws and set screws, rod pushers and rod benders, grip and compression tongs, rod cutter and distraction instrument. The principal components of the Micomed Halm Zielke Instrumentation are used in the following manner: First, the most cranial and caudal Halm plates are each attached to the lateral aspect of the vertebral body with two screws (countersunk, Zielke), and then additional plates are attached as needed. The threaded rod is then connected to the top of the Zielke screws and anchored with the standard hex nuts. Once the threaded rod is properly connected to the Halm plates, partial correction of the scoliotic deformity is performed before attaching the pre-bent fluted rod by closing the lid of the Halm plate and securing with the head screws. The secured fluted rod can then be rotated around its longitudinal axis to achieve and appropriate level of derotation and relordosation. If this system is used in the thoracic spine, rod rotation is performed in reverse to produce or enhance physiological kyphosis. Additionally, segmental compression or distraction can be used to increase or decrease lordosis or kyphosis, as desired.

AI/ML Overview

This is a summary of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria.

Note: The provided document is a 510(k) summary for a spinal instrumentation system. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance metrics against specific acceptance criteria as might be found in a clinical trial for a novel AI device. Therefore, some requested information, particularly regarding AI-specific details like training data and expert consensus for ground truth, is not applicable or available in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biomechanical Performance: Demonstrate acceptable biomechanical performance	"Testing was conducted per ASTM F1717-96. The new components have been shown to have acceptable biomechanical performance."
Equivalence to Predicate Device: Function in an equivalent manner to the predicate device	"...and to function in an equivalent manner to the predicated device."
Material Conformance: Manufactured from implant grade titanium (Ti 6AL 4V) conforming to ASTM F136 or implant grade stainless steel (316 LS) conforming to ASTM F1314 specifications.	"The components of the Micomed Halm Zielke Instrumentation are manufactured from implant grade titanium (Ti 6AL 4V) conforming to ASTM F136 or implant grade stainless steel (316 LS) conforming to ASTM F1314 specifications." (This is a design specification, implicitly met as part of the manufacturing process.)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated as this is a mechanical device study, not a data-driven AI study. The "test set" likely refers to samples of the device components subjected to biomechanical testing per ASTM F1717-96. The number of samples tested is not specified in this summary.
Data Provenance: Not applicable in the context of a 510(k) for a mechanical device. The testing is laboratory-based mechanical testing, not retrospective or prospective clinical data from a specific country.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the context of AI, refers to expert-annotated data. For this mechanical spinal instrumentation system, the "truth" is determined by established engineering standards and biomechanical testing parameters.

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically relevant for human review of data or images, especially in clinical studies or AI evaluations. For mechanical testing, results are quantitative and based on instrument readings and engineering standards.

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 device is a mechanical instrumentation system for spinal surgery, not an AI-assisted diagnostic or predictive tool for human readers.

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

Not applicable. This is not an algorithm or AI device. The "performance" refers to the mechanical integrity and function of the physical spinal implants.

7. The type of ground truth used

For the biomechanical performance, the "ground truth" is defined by the ASTM F1717-96 standard and the physical properties and performance characteristics of the predicate devices. The system is considered to meet the criteria if its biomechanical performance is equivalent to, or better than, the predicate devices when tested according to this standard.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI model. There is no concept of a "training set."

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

Not applicable, as there is no training set for a mechanical device.

Summary

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Premarket Notification for New Components for Micomed Halm Zielke Instrumentation System Reference 510(k) K982006 SEP 2 2 2003 December 12, 2002

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Attachment 12

MICOMED – HALM ZIELKE INSTRUMENTATION SYSTEM 510(K) SUMMARY

Tradename:	Micomed Halm Zielke Instrumentation System
Generic Name:	Spinal Intervertebral Body Fixation Orthosis
Classification:	Class II (21 CFR 3060)
Company:	Micomed Ortho GmbH & Co. KGSchorndorfer Strasse 96Schorndorf 73614GermanyPhone: 011 49 71 81 48 99 85 87Fax: 011 49 71 81 48 99 84info@micomed.com
Contact:	Corrine M. Bonfiglio, RACTel: (858) 342-0344Fax: (858) 481-2363cbonfiglio@meister.net
PredicateDevices:	Micomed Halm Zielke Instrumentation System, 510(k) #K982006Zielke V.D.S. System, 510(k) #K782061DePuy AcroMed MOSS Miami Spinal System, 510(k) #K983583Kaneda Anterior Scoliosis System, 510(k) #K974757
Description:	The principal components of the Micomed Halm Zielke Instrumentation System,which is a low profile spinal fixation system, are as follows: Halm and HC plates,screws, threaded rods, standard hex nuts for threaded rods, fluted rods, andvertebral clamps (double and single hole). Additional instrumentation includes:awls, wrenches, insertion instruments for rods and screws, vertebral and endvertebra screws, top loading screws and set screws, rod pushers and rod benders,grip and compression tongs, rod cutter and distraction instrument.The principal components of the Micomed Halm Zielke Instrumentation are usedin the following manner: First, the most cranial and caudal Halm plates are eachattached to the lateral aspect of the vertebral body with two screws (countersunk,Zielke), and then additional plates are attached as needed. The threaded rod isthen connected to the top of the Zielke screws and anchored with the standard hexnuts. Once the threaded rod is properly connected to the Halm plates, partialcorrection of the scoliotic deformity is performed before attaching the pre-bentfluted rod by closing the lid of the Halm plate and securing with the head screws.The secured fluted rod can then be rotated around its longitudinal axis to achieveand appropriate level of derotation and relordosation. If this system is used in thethoracic spine, rod rotation is performed in reverse to produce or enhancephysiological kyphosis. Additionally, segmental compression or distraction can beused to increase or decrease lordosis or kyphosis, as desired.
	510(k) Summary - continued
Material:	The components of the Micomed Halm Zielke Instrumentation are manufacturedfrom implant grade titanium (Ti 6AL 4V) conforming to ASTM F136 or implantgrade stainless steel (316 LS) conforming to ASTM F1314 specifications.
Indications:	The Halm Zielke Instrumentation System is an anterior spinal fixation systemindicated for spinal deformities in the thoracic and lumbar spine such as scoliosis,kyphosis, and lordosis and thoracolumbar spinal instability caused by fracture.
Performance:	Testing was conducted per ASTM F1717-96. The new components have beenshown to have acceptable biomechanical performance and to function in anequivalent manner to the predicated device.
SubstantialEquivalence:	The new components for the Micomed Halm Zielke Instrumentation System aresubstantially equivalent in function, performance and intended use to the predicateHalm Zielke instrumentation cleared for market entry under 510(k) #K982006 onJanuary 20, 1999; the Zielke V.D.S System cleared for market entry on March 21,1979; the DePuy AcroMed MOSS Miami Spinal System, cleared for market entryunder 510(k) #K983583 on December 3, 1998; and the Kaneda Anterior ScoliosisSystem (KASS), cleared for market entry under 510(k) #K974757, on March 5,1998.

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Premarket Notification for New Components for Micomed Halm Zielke Instrumentation System Reference 510(k) K982006

December 12, 2002

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DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2003

Micromed Ortho GmbH & Co. KG c/o Ms. Corrine M. Bonfiglio, RAC 13195 Seagrove Street San Diego, California 92130

Re: K024125

Trade/Device Name: Halm Zielke Instrumentation System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: August 7, 2003 Received: August 11, 2003

Dear Ms. Bonfiglio:

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 - Ms. Corrine M. Bonfiglio, RAC

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), 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). You may obtain other general information on your responsibilities under the Act 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,

e. Mark N Milliman

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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Premurket Notification for New Components for Micomed Halm Zielke Instrumentation System Reference 510(k) K982006 December 12, 2002

Attachment 11

Statement of Indication for Use

510(k) Number: KD24125

Device Name: Micomed Halm Zielke Instrumentation System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark A. Milliman
Division Sign Off

Di ision of General, Restorative and Neurological Devices

510(k) Number -

i(k) Number ___ KV24/23

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use

(Optional Format 1-2-96)

201

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.