The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® cannulated screws are intended for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are 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. Refer to the VERTEX™ Reconstruction System Package Insert for a list of the VERTEX™ indications of use.

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, hooks, 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 seek the additional pedicle screw indication of degenerative disc disease for the 5.5mm and 6.35mm CD HORIZON® rods and associated components.

AI/ML Overview

This document is a 510(k) summary for the CD HORIZON® Spinal System, a medical device. It does not describe an AI/ML device or a study proving its performance against acceptance criteria. Instead, it describes a substantial equivalence determination for a traditional medical device (spinal fixation system) based on comparing it to existing, legally marketed predicate devices.

Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, ground truth, expert involvement, and AI-specific details cannot be extracted or are not applicable to this document.

Here's what can be stated based on the provided text:

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

Acceptance Criteria: The primary "acceptance criteria" here is substantial equivalence to predicate devices. This means the device must be as safe and effective as a legally marketed device that was on the market before May 28, 1976, or to a device that has been reclassified. The specific criteria are demonstrated by comparing the device's indications for use, technological characteristics, and safety/effectiveness profile to the predicate devices.
Reported Device Performance: The document doesn't provide specific performance metrics in the way one would for an AI model (e.g., sensitivity, specificity, AUC). Instead, it asserts that "Documentation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to the TSRH® Spinal System, the CD® Spinal System and the TOWNLEY™ Plating System for the additional indication of Degenerative Disc Disease."

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. This document describes a medical device submission based on substantial equivalence, not an AI/ML performance study with a test set. There is no mention of a "test set" in the context of data used to evaluate an algorithm's performance.

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. There is no mention of a "test set" or ground truth established by experts for performance evaluation in this document. The "ground truth" for this type of submission is the safety and efficacy of the predicate devices.

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

Not applicable. No test set or adjudication method for performance evaluation 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 not a study involving human readers or AI assistance.

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

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

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

The "ground truth" implicitly used for the substantial equivalence determination is the established safety, efficacy, and intended use of the predicate devices (TSRH® Spinal System, CD® Spinal System, and TOWNLEY™ Plating System). The new device is deemed acceptable if it is found to be as safe and effective as these previously cleared devices.

8. The sample size for the training set

Not applicable. This document does not describe a training set for an AI model.

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

Not applicable. This document does not describe a training set for an AI model.

Summary of Device and Approval Type:

Device: CD HORIZON® Spinal System (spinal fixation device)
Approval Type: 510(k) clearance based on Substantial Equivalence.
Key Information Provided: Product description, indications for use (including the new indication for degenerative disc disease), and the predicate devices used for comparison. The letter from the FDA confirms the substantial equivalence determination.

Summary

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

32033
page 1 of 2

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

I. Company: Medtronic Sofamor Danek, Inc. USA 1800 Pyramid Place Memphis. TN 38132 (901) 396-3133
II. Proposed Proprietary Trade Name: CD HORIZON® Spinal System
III. Classification Name: Spinal Interlaminal Fixation and Spinal Intervertebral Fixation 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 seek the additional pedicle screw indication of degenerative disc disease for the 5.5mm and 6.35mm CD HORIZON® rods and associated components.

V. Indications

The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used in a percutaneous, non-cervical, posterior approach with the SEXTANT

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

K032035
page 2 of 2

instrumentation. the CD HORIZON® cannulated screws are intended for the follow degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are 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.

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. Refer to the VERTEXTM Reconstruction System Package Insert for a list of the VERTEX™ indications of use.

VI. Substantial Equivalence

Documentation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to the TSRH® Spinal System, the CD® Spinal System and the TOWNLEY™ Plating System for the additional indication of Degenerative Disc Disease.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

SEP 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K032033

Trade/Device Name: CD HORIZON® Spinal System Regulatory Number: 21 CFR 888.3070 (b)(1), 888.3050, 888.3060 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis Regulatory Class: III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: June 27, 2003 Received: July 1, 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. Iisting 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.

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

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

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,

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

{4}------------------------------------------------

Page 1 of 1 September 2003

510(k) Number (if known): K032033

Device Name: CD HORIZON® Spinal System

Indications for Use:

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

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over-the-counter Use - - -

(Optional 1-2-96)
Miriam C. Provost

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

510(k) Number K032033

Regulation Number and Section

N/A