The CD Horizon™ Spinal System with or without SEXTANT™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fosion for the following indications: degenerative disc disease (DDD - 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, tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, the CD Horizon™ LEGACY™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ PEEK Rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.

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 shapes and sizes of rods, hooks, screws, Crosslink™ Plates, staples and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

A subset of CD Horizon™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, Crosslink™ plates and connecting components. Similar to the CD Horizon™ implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

AI/ML Overview

The provided document is a 510(k) summary for the Medtronic CD Horizon™ Spinal System. It focuses on demonstrating substantial equivalence to existing predicate devices, primarily by showing that the new device has the same intended use, indications, fundamental scientific technology, materials, and sterilization method, with the key difference being that the subject devices are provided sterile.

The document does not describe an AI/ML-driven device or study involving acceptance criteria related to AI/ML performance metrics such as accuracy, sensitivity, specificity, or human reader improvement. The "performance data" section refers to mechanical testing, biocompatibility, and bacterial endotoxin testing, typical for a physical medical implant, not a software or AI/ML device.

Therefore, it's not possible to extract the information requested in your prompt based on the provided text, as it pertains to an entirely different type of medical device (a mechanical spinal implant) and its regulatory submission.

To answer your request, if the provided document were for an AI/ML device, the following would typically be found (but is absent here):

Acceptance Criteria Category	Specific Acceptance Criteria (Example)	Reported Device Performance (Example)
Standalone Performance	Sensitivity >= 90% for detecting X condition	92.5%
	Specificity >= 85% for detecting X condition	87.1%
	AUC >= 0.90 for condition Y	0.93
Human-in-the-Loop Performance (if applicable)	Radiologist agreement (F1-score) improves by 5% with AI assistance	7.2% improvement
	Reader sensitivity increases by 5% with AI assistance	6.1% increase
	False positive rate decreases by X% with AI assistance	15% decrease
Robustness/Generalizability	Maintain specified performance across different scanner types/hospitals	Achieved across N sites/M scanner models
Usability/Workflow	Integration compatible with existing PACS systems	Successful integration demonstrated

Regarding the study details, based on a hypothetical AI/ML device submission, you would typically look for:

Sample size for the test set and data provenance: Number of images/cases. Origin (e.g., US, Europe, multi-country), and whether data was collected retrospectively or prospectively.
Number of experts and qualifications for ground truth: How many clinicians (e.g., radiologists, pathologists) annotated the data. Their specialty, board certification status, years of experience.
Adjudication method for the test set: How disagreements among experts were resolved (e.g., majority vote, senior expert, consensus read, 2+1 means two initial readers and a third to resolve discrepancies).
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: If conducted, details on the study design (e.g., crossover, paired), the number of readers, the effect size (e.g., how much human readers' performance metrics like AUC, sensitivity, or specificity improved with AI assistance compared to without).
Standalone performance: Metrics (e.g., sensitivity, specificity, AUC) achieved by the algorithm alone, without human intervention.
Type of ground truth: How the "truth" was established (e.g., expert consensus, biopsy, surgical confirmation, long-term patient outcomes, follow-up imaging, synthesis of multiple data points).
Sample size for the training set: Number of images/cases used to train the AI model.
How ground truth for the training set was established: Similar to the test set, but sometimes less stringent or with programmatic labeling.

In summary, the provided document does not contain any of the information requested because it pertains to a mechanical medical device (spinal implant) and not an AI/ML-driven software device.

Summary

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September 8, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services seal. To the right of the seal is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bold blue font. Below that is the word "ADMINISTRATION" in a smaller, non-bold blue font.

Medtronic Sofamor Danek USA, Inc. Venkata Sandeep Manne Associate Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K202328

Trade/Device Name: CD Horizon™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: August 10, 2020 Received: August 17, 2020

Dear Mr. Manne:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Colin O'Neill, MBE Assistant Director DHT6B: Division of Spine Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202328

Device Name CD Horizon™ Spinal System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

MEDTRONIC Sofamor Danek USA, Inc.

CD HORIZON™ Spinal System

August 2020

I.	Submitter	Medtronic Sofamor Danek, USA Inc.
		1800 Pyramid Place
		Memphis, Tennessee 38132
		Telephone: (901) 396-3133
	Contact:	Venkata Sandeep Manne
		Associate Regulatory Affairs Specialist
		Email: venkatasandeep.manne@medtronic.com
	Date Prepared:	August 10, 2020
II.	Subject Device
	Name of Device:	CD HORIZON™ Spinal System
	Product Codes:	NKB, KWP, KWQ
	Common name:	Spinal Fixation Appliance, Spinal Fixation Orthosis
	ClassificationName:	Thoracolumbosacral pedicle screw system (21 CFR 888.3070);Spinal Interlaminal Fixation Orthosis (21 CFR 888.3050);Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060)
	Classification	Class II
III.	PredicateDevices:	Predicate 1 (Primary Predicate):CD HORIZON™ Spinal System- K182928 (S.E. 01/11/2019)
		Predicate 2 (Additional Predicate):CD HORIZON™ Spinal System- K113174 (S.E. 11/21/2011)
		Predicate 3 (Additional Predicate):CD HORIZON™ Spinal System- K162379 (S.E.11/16/2016)The predicate devices were not subjected to any Recall.
IV.	Description:	The CD Horizon™ Spinal System consists of a variety of shapes and sizesof rods, hooks, screws, Crosslink™ Plates, staples and connectingcomponents, as well as implant components from other Medtronic spinalsystems which can be rigidly locked into a variety of configurations, witheach construct being tailor-made for the individual case.A subset of CD Horizon™ Spinal System components may be used forposterior pedicle screw fixation in pediatric cases. These constructs maybe comprised of a variety of shapes and sizes of rods (ranging in diameterfrom 3.5mm to 6.35mm), hooks, screws, Crosslink™ plates andconnecting components. Similar to the CD Horizon™ implants used inadult cases, these components can be rigidly locked into a variety ofconfigurations, with each construct being tailor-made for the individualcase.
V.	Indications foruse	The CD Horizon™ Spinal System with or without SEXTANT™instrumentation is intended for posterior, non-cervical fixation as anadjunct to fusion for the following indications: degenerative disc disease(DDD - defined as back pain of discogenic origin with degeneration of thedisc confirmed by history and radiographic studies), spondylolisthesis,trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e.scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failedprevious fusion.Except for hooks, when used as an anterolateral thoracic/lumbar system,the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless-steel implants may also be used for the same indications as an adjunct tofusion.With the exception of DDD, the CD Horizon™ Legacy™ 3.5mm rods andassociated components may be used for the aforementioned indicationsin skeletally mature patients as an adjunct to fusion. The 3.5mm rods maybe used for the specific pediatric indications noted below.

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When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless-steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When used with CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor. 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.

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VI.	Comparison ofTechnologicalCharacteristicswith thePredicateDevices	The subject CD HORIZON™ Spinal System have the same intended use,indications, fundamental scientific technology, material, and sterilizationmethod as the previously FDA cleared CD HORIZON™ Spinal Systempredicates. The primary difference between predicate devices andsubject devices is that the subject devices are provided Sterile. Thematerials, thread forms, and sizes of the subject devices fall within thecleared range of the CD HORIZON™ Spinal system predicate devices anddoes not raise any issues on safety and effectiveness.

	Both Subject and Predicate devices are based on the same technologicalcharacteristics of providing posterior, non-cervical fixation as an adjunctto fusion for the following indications: degenerative disc disease (DDD -defined as back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies), spondylolisthesis, trauma(i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis,kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previousfusion.

	The design features, materials and indications for use of the subjectdevices are substantially equivalent to the previously cleared predicatesCD HORIZON™ Spinal System K182928(S.E. 01/11/2019), and CDHORIZON™ SOLERA™ Spinal System K113174 (S.E. 11/21/2011)Therefore, the technological characteristics of the subject devices areidentical to the predicate devices. The subject devices are providedgamma sterilized similar to the predicate devices cleared in CD Horizon™Spinal system K162379 (S.E.11/16/2016).

	VII.	PerformanceData	Mechanical Testing:In accordance with, "Guidance for Industry and FDA Staff – SpinalSystem 510(k)'s", Medtronic has evaluated the subject devices todemonstrate substantial equivalence to the predicate devices.Medtronic completed both an engineering rationale and a risk analysisin accordance with Medtronic design control procedures. Both


	evaluations demonstrated that the subject devices do not introduce anew worst case to the CD HORIZON™ Spinal System.Biocompatibility:The subject CD HORIZON™ Spinal System implants are permanentimplants (> 30 days) and will be classified as body contacting devicesaccording to FDA's Draft Guidance for Industry and FDA Staff "Use ofInternational Standard ISO-10993, Biological Evaluation of MedicalDevices Part 1: Evaluation and Testing". The subject implants aremanufactured from identical materials as the predicate devices, inaccordance with the following standards:ASTM F136 -Standard Specification for Wrought Titanium –6Aluminum – 4Vanadium ELI (Extra-Low-Interstitial) Alloy forSurgical Implants ASTM F67 - Standard Specification for Unalloyed Titaniumfor Surgical Implant Applications ASTM F1537 - Standard Specification for Wrought Cobalt –28Chromium 6Molybdenum Alloys for Surgical Implants. The materials used for manufacturing the subject device have a longhistory of safe and effective use identical to predicate spinal implants.Bacterial Endotoxin Testing:The bacterial endotoxin test, also known as Limulus amebocyte lysate(LAL) test, was performed utilizing worst case subject implants to verifythat the subject implants meet the 20 endotoxin units (EU)/devicepyrogen limit specification. Testing was successfully performed, and itwas confirmed that the subject implants meet the 20 EU/device testinglimit for general medical devices that are implanted as outlined inANSI/AAMI ST72, Bacterial endotoxins – Test methods, routinemonitoring, and alternatives to batch testing and USP <161>, MedicalDevices – Bacterial Endotoxin and Pyrogen Tests.
VIII.	Conclusion:	Based on the supporting information provided in this pre-marketnotification, the subject CD Horizon™ Spinal System is substantiallyequivalent to the following predicates:Predicate 1 (Primary Predicate) CD HORIZON™ Spinal System K182928 (S.E. 01/11/2019) Predicate 2 (Additional Predicate) CD HORIZON™ Spinal System K113174 (S.E. 11/21/2011) Predicate 3 (Additional Predicate) CD HORIZON™ Spinal System K162379 (S.E.11/16/2016)

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Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.