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 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.

In addition, 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.

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.

The CD HORIZON® system is also 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 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) turnor resection, and/or (8) failed previous fusion.

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.

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 add titanium 4.5mm rods and associated components for posterior use for patients of smaller stature.

AI/ML Overview

This document is a 510(k) premarket notification for the CD HORIZON® Spinal System. It outlines the product description, indications for use, and confirms substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

Table of acceptance criteria and the reported device performance

This document does not report specific acceptance criteria or quantitative device performance metrics in the way one would expect for a diagnostic or AI-driven medical device. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, a table cannot be generated in the traditional sense of acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and reported performance values. The "performance" being evaluated here is the safety and effectiveness of the device as a spinal implant system, implicitly by showing it is as safe and effective as a previously approved device.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a "test set" or provide information related to a study with patient data or clinical outcomes for a novel device. The submission is a 510(k) premarket notification, which relies on demonstrating substantial equivalence. This typically involves comparing the new device's technological characteristics and proposed indications for use to those of a legally marketed predicate device.

There is no mention of patient data, clinical trials, or any form of a "test set" from a specific country or study type (retrospective/prospective) for this specific submission.
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)

As there is no described "test set" or clinical study with patient data for ground truth establishment, this information is not applicable and not provided in the document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

Similarly, as there is no described "test set" or clinical study, an adjudication method is not applicable and not provided.
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

This device is a spinal implant system (mechanical hardware), not an AI-driven or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and not mentioned in this document.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Again, as this is a spinal implant system, not an algorithm or AI device, a standalone performance study as described is not applicable and not present in the document.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" as typically used for AI/diagnostic devices (e.g., pathology for cancer diagnosis) is not directly applicable to this 510(k) submission for a spinal implant. The "proof" for this device lies in demonstrating its substantial equivalence in terms of design, materials, and intended use to an existing legally marketed device, implying comparable safety and effectiveness.
- For such mechanical devices, "ground truth" might indirectly relate to successful long-term clinical outcomes of the predicate device, but this document does not detail specific "ground truth" methodologies for its own assessment.
The sample size for the training set

This document describes a spinal implant system, not a machine learning model. Therefore, there is no "training set" as understood in the context of AI/algorithms, and no sample size for such a set is provided.
How the ground truth for the training set was established

As there is no training set mentioned, the establishment of its ground truth is not applicable.

Summary of the Study Proving Acceptance Criteria (Substantial Equivalence):

The "study" or justification for the device meeting acceptance criteria in the context of this 510(k) submission is a demonstration of substantial equivalence to itself (the CD HORIZON® Spinal System) and other existing predicate devices from Medtronic Sofamor Danek.

The document states: "Documentation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to itself." This implies that the specific submission (K020709) is either for a minor modification or an expansion of the existing CD HORIZON® Spinal System (e.g., adding titanium 4.5mm rods for posterior use for smaller stature patients, as mentioned in Section III).

The FDA's letter confirms this by stating they reviewed the premarket notification and "determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

Therefore, the "acceptance criteria" here are the regulatory requirements for showing that the modified or expanded device is as safe and effective as a legally marketed predicate device, without requiring a Pre-Market Approval (PMA). This is typically achieved through:

Comparison of Indications for Use: Ensuring the proposed indications are the same or very similar to the predicate.
Comparison of Technological Characteristics: Demonstrating that differences in design, materials, or performance characteristics do not raise new questions of safety and effectiveness.
Performance Data (if necessary): Depending on the changes, bench testing, biocompatibility testing, or other non-clinical data might be required to support the equivalence claim. However, this document does not detail such specific testing in K020709.

In essence, the "study" is the 510(k) submission itself, where the applicant provides a detailed comparison and justification, which the FDA then reviews to determine substantial equivalence. No specific clinical trial or performance study on a "test set" for this particular submission is described in the provided text.

Summary

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MAY 0 9 2002

CD HORIZON® Spinal System Summary of Safety and Effectiveness February 2002

Medtronic Sofamor Danek, Inc. USA I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133

II. Proposed Proprietary Trade Name: CD HORIZON® Spinal System

III. Product Description

The purpose of this 510(k) submission is to add titanium 4.5mm rods and associated components for posterior use for patients of smaller stature.

IV. 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:

Image /page/0/Picture/14 description: The image shows a sequence of numbers, specifically "00047". The numbers are printed in a bold, sans-serif font. The image appears to be a close-up of the numbers, possibly extracted from a document or label.

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

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, studies), (2) spinal trencess (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The CD HORIZON® system is also 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: mature parents, and od isthesis 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 in dicated 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 nraft 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 outil pannes and issues as a 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.

Substantial Equivalence V.

Documentation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to itself.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.

MAY 0 9 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Richard W. Treharne, PhD Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis. Tennessee 38132

Re: K020709

Trade/Device Name: CD HORIZON® Spinal System Regulation Number: 21 CFR §888.3050, §888.3060, §888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis and Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, KWQ, MNH, MNI Dated: April 8, 2002 Received: April 9, 2002

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.

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Page 2 - Mr. Richard W. Treharne, PhD

You must comply with all the Act's requirements, including, but not limited to: registration and 1 our mast compt) what 7); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in als qualify is novisions (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) This icitication. The FDA finding of substantial equivalence of your device to a legally premarket notineadon. The PDF mailing of evice 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 11 you desire specific arrive ter from vitro diagnostic devices), please contact the Office of additionally 21 CT IC For 007.10 for m-raally, for questions on the promotion and advertising of Compliance at (301) 597-1007 Transe Compliance at (301) 594-4639. Also, please note the your do roo, proad "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation onlined, "Thisocialisms on your responsibilities under the Act may be obtained from the Other general information on Jour responsive 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,

Muriam C. Provost

for 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

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Page 1 of 2 February 2002

510(k) Number (if known): K020709

Device Name: ___________CD HORIZON® Spinal System

Indications for Use:

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:

In addition, 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 (LS-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.

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

000158

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

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-the-counter Use

(Optional 1-2-96)

Muriam C. Provost

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

510(k) Number K020769

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.