When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZON® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal turnor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the CD HORIZON® Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the CD HORIZON® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for the following indications:

When used as a pedicle screw fixation system the CD HORIZON® Cannulated M8 Multi-Axial Screw components are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (d) who are having the device removed after the development of a solid fusion mass.

In addition, when used as a posterior spine thoracic/lumbar system, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e. degenerative scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The CD HORIZON® ECLIPSE® components are intended for the following indications: When used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX™ Reconstruction System with the VERTEX™ rod connector. When connecting to the VERTEX™ Reconstruction System in the cervical spine, components are intended for the following indications:

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the VERTEX™ Reconstruction System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Lateral Connectors

The use of VERTEX™ multi-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The multi-axial screws are not intended to be placed in the cervical spine.

Titanium ATLAS™ Cable and the CD HORIZON® Spinal System may be used with the VERTEX™ Reconstruction System.

Device Description

The CD HORIZON® Spinal System consists of a variety of rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The CD HORIZON® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.

Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH® rods, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK PLUS® bolts; and Medtronic Sofamor Danek Multi-Axial rods and screws.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and screws are intended for anterior use only. However, for patients of smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

The purpose of this 510(k) submission is to include additional VERTEX™ RECONSTRUCTION System connectors and hooks to the CD HORIZON® Spinal System.

AI/ML Overview

The provided document describes the CD HORIZON® Spinal System and its indications for use, as well as the substantial equivalence determination by the FDA. However, it does not contain information about a study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or any other quantitative measure that would typically be associated with a device's performance in a diagnostic or AI context.

Instead, this document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. This process typically involves showing that the new device has the same intended use and technological characteristics as the predicate, or, if there are differences, that those differences do not raise new questions of safety and effectiveness.

Therefore, many of the requested details about acceptance criteria, device performance, study design, and ground truth are not present in this type of regulatory submission.

Here's a breakdown of what can be extracted or inferred from the document regarding the device's acceptance:

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

This document does not define explicit "acceptance criteria" in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity, AUC) for the device itself. The "acceptance" mentioned here refers to the FDA's determination of substantial equivalence to predicate devices. The "performance" reported is inherent in the device being granted substantial equivalence, implying it performs as safely and effectively as the predicate devices for its stated indications.

Acceptance Criterion (Implicit)	Reported Device Performance (Implicit)
Substantial Equivalence to predicate devices for safety and effectiveness	Device found substantially equivalent to legally marketed predicate devices for its stated indications.

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

Sample Size for Test Set: Not applicable/Not provided. The document describes a regulatory submission for substantial equivalence, not a clinical performance study with a distinct test set.
Data Provenance: Not applicable/Not provided. The document does not refer to specific patient data used for evaluation of the device's performance in a clinical study.

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

Not applicable/Not provided. There is no mention of a ground truth established by experts for a test set in this document, as it is a regulatory submission for substantial equivalence, not a performance study.

4. Adjudication method for the test set:

Not applicable/Not provided. No test set is described.

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 a medical device (spinal implant system), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to "human readers improving with AI" is not relevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

Not applicable. The concept of "ground truth" as used in performance studies (e.g., pathology, outcomes data) is not present in this substantial equivalence document for a spinal implant system. The "truth" in this context is the safety and effectiveness of the existing predicate devices.

8. The sample size for the training set:

Not applicable/Not provided. There is no training set described as this is not an AI/algorithmic device.

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

Not applicable/Not provided. There is no training set.

Summary of the Study (i.e., the basis for approval):

The "study" or basis for acceptance in this context is the FDA's review of the 510(k) submission (K030932). The manufacturer (Medtronic Sofamor Danek, Inc. USA) submitted documentation to demonstrate Substantial Equivalence of the CD HORIZON® Spinal System (specifically the addition of 3.2/4.5 Connector and hooks) to previously cleared predicate devices.

The FDA reviewed this submission and determined that 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... or to devices that have been reclassified..."

The document explicitly states under VI. Substantial Equivalence: "Documentation was provided which demonstrated the subject rod connectors and hooks to be substantially equivalent to the previously cleared CD HORIZON® Spinal System components."

This means the acceptance of the device was based on a comparison to existing, legally marketed spinal fixation systems, confirming that the new components perform in a similar manner and have similar indications for use, without raising new questions of safety or effectiveness. No specific performance metrics from a clinical trial are provided or required for this type of submission when demonstrating substantial equivalence.

Summary

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CD HORIZON® Spinal System Summary of Safety and Effectiveness March 2003

MAY 1 6 2003

Medtronic Sofamor Danek, Inc. USA I. Company: 1800 Pyramid Place Memphis. TN 38132 (901) 396-3133
Proposed Proprietary Trade Name: CD HORIZON® Spinal System II.
Classification Name: Spinal Interlaminal Fixation and Spinal Intervertebral Fixation III. Orthosis and/or Pedicle Screw Spinal System (per 21 CFR Section 888.3050, 888.3060 and/or 888.3070)

IV. Product Description

The purpose of this 510(k) submission is to include additional VERTEX™ RECONSTRUCTION System connectors and hooks to the CD HORIZON® Spinal System.

V. Indications

The CD HORIZON® system is intended for the following indications:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZON® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the CD HORIZON® Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the

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K 0 3 0 9 3 2
page 2 of 3

fifth lumbar-first sacral (LS-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for the following indications:

When used as a pedicle screw fixation system the CD HORIZON® Cannulated M8 Multi-Axial Screw components are also indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (d) who are having the device removed after the development of a solid fusion mass.

In addition, when used as a posterior spine thoracic/lumbar system, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e. degenerative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The CD HORIZON® ECLIPSE® components are intended for the following indications:

When used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the VERTEX™ Reconstruction System is indicated for the following:

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page 3 of 3

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Lateral Connectors

Titanium ATLAS™ Cable and the CD HORIZON® Spinal System may be used with the VERTEXTM Reconstruction System.

VI. Substantial Equivalence

Documentation was provided which demonstrated the subject rod connectors and hooks to be substantially equivalent to the previously cleared CD HORIZON® Spinal System components.

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Image /page/3/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 bird in flight, composed of three stylized lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard W. Treharne, Ph.D. Vice President Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

MAY 1 6 2003

Re: K030932

Trade Name: CD Horizon® Spinal System (Addition of 3.2/4.5 Connector) Regulation Number: 21 CFR 888.3070, 21 CFR 888.3060, 21 CFR 888.3050 Regulation Name: Pedicle screw spinal System, Spinal intervertebral body fixation orthosis, Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: MNI, MNH, KWQ, KWP Dated: May 5, 2003 Received: May 6, 2003

Dear Dr. Treharne:

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

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Page 2 - Richard W. Treharne, Ph.D.

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. 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,

Mark N. Millman

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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510(k) Number (if known): K O 3

CD HORIZON® Spinal System Device Name:

Indications for Use:

The CD HORIZON® system is intended for the following indications:

When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for the following indications:

Mark A. Millikan

al, Restorative

510(k) Number K030932

(Continued on the next page)

000130

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When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the VERTEX™ Reconstruction System is indicated for the following:

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Lateral Connectors

Titanium ATLAS™ Cable and the CD HORIZON® Spinal System may be used with the VERTEX™ Reconstruction System.

(PLEASE DO NOT WRITE BELOW THIS LINE------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Evaluation (ODE)

OR Prescription Use (Per 21 CFR 801.109)

Over-the-counter Use

(Optional 1-2-96)

for Mark N Millican

D,
and

510(k) Number K030932

000137

Regulation Number and Section

N/A