The K-Centrum Anterior Spinal Fixation System is intended for alignment correction and stabilization of the thoracolumbar spine. The K-Centrum is also intended to provide stabilization to augment the development of a solid spinal fusion. The K-Centrum is intended for threaded anchor/ fixation attachment to the anterolateral intervertebral bodies from T10 to L2 only and not more than 2 motion segments. The K-Centrum is indicated for vertebral body fractures and tumors.

The K-Centrum Anterior Fixator is intended for correction and stabilization of the spine. The K-Centrum is also intended to provide temporary stabilization and augment the development of a solid spinal fusion. The K-Centrum is intended for screw/bolt/fixation attachment to the anterolateral intervertebral bodies from T10 to L5 only and less than 4 motion segments.

The K-Centrum is indicated for degenerative disk disease, disk herniation, spondylosis, spondylolisthesis, burst fracture, failed surgery, corpectomy or vertebrectomy for tumor resection.

Device Description

The K-Centrum Anterior Spinal Fixation System is a multi-component system. The construct utilizes all of the following implantable components: Vertebral Body Anchors (Two); Linkage rod (One); Set screws (Two); Locking caps (Two). The K-Centrum System includes unique instrumentation to assist the surgeon in placing the anchors parallel to each other.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the K-Centrum Anterior Spinal Fixation System. It focuses on demonstrating substantial equivalence to a predicate device through technological comparisons and mechanical testing, rather than clinical performance or AI-driven acceptance criteria. Therefore, most of the requested information regarding AI device evaluation is not applicable to this document.

Here's an analysis based on the provided text:

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

Acceptance Criteria (Implied)	Reported Device Performance
Perform comparably to the predicate device (Z-Plate).	"Results from comparative mechanical testing results shows that the K-Centrum performs comparably to the Z-Plate."
Exceed minimum performance requirements outlined in the FDA guidance document, "Device Considerations for Spinal Fixation Device Systems", FDA, 1993.	"both devices exceed the minimum performance requirements outlined in the FDA guidance document, 'Device Considerations for Spinal Fixation Device Systems', FDA, 1993."
No new types of safety or effectiveness questions raised.	"No new types of safety or effectiveness questions were raised as a result of the testing or risk analysis performed for the K-Centrum Anterior Spinal Fixation System."
Material composition (Ti-6A1-4V, ELI) in accordance with ASTM F 136 - 96.	"Both devices are manufactured from the same titanium alloy (Ti-6A1-4V, ELI), in accordance with the same standard material specification (ASTM F 136 - 96)."
Similar design features (anchors, longitudinal elements, locking mechanisms).	"Both system configurations include anchors, longitudinal elements for linkage, and locking mechanisms." (Details on differences in anchor geometry for direct bone contact, rod shape, and locking mechanism are also noted, but deemed substantially similar)

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

Sample Size: Not specified. The document refers to "testing" and "results from comparative mechanical testing" but does not quantify the number of units or tests conducted for the mechanical evaluations.
Data Provenance: Not specified. The data appears to be from in-vitro mechanical testing conducted by the manufacturer, Spineology, Inc. There is no mention of clinical data, country of origin related to patient data, or whether it was retrospective or prospective.

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. This device is a spinal fixation system, and the evaluation described is based on mechanical testing standards and engineering comparisons to a predicate device, not on expert-adjudicated ground truth as would be relevant for an AI system. The FDA guidance document itself would represent a consensus of expert knowledge in biomechanical testing, but not individual expert adjudication of data.

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

Not applicable. This concept applies to human-based assessment of data, typically in diagnostic or prognostic studies, not to mechanical testing of physical devices against established 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 is not an AI device. The study described is a mechanical comparison of a medical implant to a predicate device.

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

Not applicable. This is not an AI device.

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

The "ground truth" for the device's performance is based on established mechanical testing standards (ASTM 1717-96) and FDA guidance document "Device Considerations for Spinal Fixation Device Systems" (1993). The comparison to the predicate device (Z-Plate ATL Anterior Fixation System) also serves as a benchmark for "comparable" performance.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no "training set."

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

Not applicable. This is not an AI device, so there is no "training set" or ground truth for it in this context.

Summary

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SPINEOLOGY, INC

11:25 DEC-22-1999 Spineology Group Premarket Notification K-Centrum Anterior Spinal Fixation System

DEC 27 1995

K990959

510(k) Summary [As required by 21 CFR 807.92(c)] 4

4.1 Submitter Information

Manufacturer's Name & Address Manufacturer's Contact Person Pamela Snyder Spineology Group, LLC Director of Clinical & Regulatory Affairs 1815 Northwestern Avenue Phone: 651-351-1011 Fax: 651-351-0712 Stillwater, MN 55082

4.2 Device Names

Proprietary Name:	K-Centrum Anterior Spinal Fixation System
Common/Usual Name:	anterior spinal fixation device
FDA Classification Name:	21 CFR 888.3060, Spinal Intervertebral Body Fixation Orthosis
FDA Classification:	Class II, product code KWQ

Predicate device 4.3

Manufacturer	Device	510(k)	Approved
Sofamor Danek	Z-Plate Anterior Fixation System	K922543	5/19/93

Device Description ব

4.5 Intended Use

Technological Characteristic Comparisons 4.6

In addition to having comparable intended use and indications for use, the K-Centrum Anterior Spinal Fixation System and the Sofamor Danek Z-Plate ATL Anterior Fixation System are substantially similar in design features. Both devices are manufactured from the same titanium alloy (Ti-6A1-4V, ELI), in accordance with the same standard material specification (ASTM F 136 - 96). Both system configurations include anchors, longitudinal elements for linkage, and

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March 18, 1999

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Spineology Group Premarket Notification K-Centrum Anterior Spinal Fixation System

locking mechanisms. For safety reasons, the K-Centrum has been designed to be a low-profile implant, to minimize the opportunity for device impingement on soft tissues and vascular structures. Anchors for both systems are secured to the vertebral body by threaded attachment. The details of anchor geometry differ, in part because the Z-Plate utilizes two small diameter anchors in each vertebral body, while the K-Centrum employs a single larger diameter anchor. Both anchor systems provide comparable surface area for direct bone contact. The longitudinal linkage elements are of different configurations. The K-Centrum utilizes a round-cornered rectangular rod, nearly symmetrical in the transverse plane, for linkage; the Z-Plate has a contoured, relatively wide plate, asymmetrical in the transverse plane. Both linkage elements are designed to resist tension, compression, bending, and torsion. In both the K-Centrum and Z-Plate systems, the linkage component is secured to the anchors via a threaded clamping locking component: a locking nut for the Z-Plate, a set screw and locking cap for the K-Centrum.

Summarv of Testing 4.7

Results from comparative mechanical testing results shows that the K-Centrum performs comparably to the Z-Plate, and both devices exceed the minimum performance requirements outlined in the FDA guidance document, "Device Considerations for Spinal Fixation Device Systems", FDA, 1993. The testing included: Static Testing per ASTM 1717-96; Fatigue Testing per ASTM F 1717-96; Interconnection Testing: Set screw to linkage rod; Simulated Use Testing of Anchor Guidance System; and Comparative Anchor Pullout Testing. No new types of safety or effectiveness questions were raised as a result of the testing or risk analysis performed for the K-Centrum Anterior Spinal Fixation System.

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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 stylized bird in flight, with three curved lines representing the wings. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 27 1999

Ms. Pamela Snyder Director of Clinical and Regulatory Affairs The Spineology Group, LLC 1815 Northwestern Avenue Stillwater, Minnesota 55082

Re: K990959

Trade Name: K-Centrum Anterior Spinal Fixation System Regulatory Class: II Product Code: KWQ Dated: September 28, 1999 Received: September 30, 1999

Dear Ms. Snyder:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Ms. Pamela Snyder

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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Neil R.P. Ogden
James E. Dillard III

Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INTENDED USE STATEMENT

Kgquggyyy

510(k) Number (if known):

Device Name: K-Centrum Anterior Spinal Fixation System

Indications for Use:

DLU CLE LE - LE

The K-Centrum is indicated for degenerative disk disease, disk herniation, spondylosis, spondylolisthesis, burst fracture, failed surgery, corpectomy or vertebrectomy for tumor resection.

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)	ARE for JZD
Division of General Restorative Devices
510(k) Number	K990959

Prescription Use YES
(Per 21 CFR 801.109)

Page 1 of 1

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.