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The CD HORIZON® Spinal System without SEXTANT® instrumentation is intended for posterior, non-ecryical fixation as an adjunct to fusion for the following indications: degencrative 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion,

With the exception of degeneralive discase, the CD HORIZON® LEGACY™ 3,5mm rods and the CD HORUZON® Spinal System PEEK 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 indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatic patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis) 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: spondylolishesis 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.

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: degenerative disc disease (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.

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 tailormade 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. Similarly 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.

The purpose of this Special 510(k) is the modifications of implants for the CD HORIZON® Spinal System. The modifications to the implants are adding additional sizes of cannulated multi-axial screws (MAS), print updates for a rebaselining of existing closed lateral connectors, and adding additional sizes of SEXTANT® pre-bent rods with different tip geometries and connection types.

This document is a 510(k) Summary for the Medtronic CD HORIZON® Spinal System. It is a premarket notification to the FDA to demonstrate substantial equivalence to previously cleared devices. Therefore, it does not describe a study to prove a device meets acceptance criteria in the typical sense of a clinical trial or performance study for a novel AI/software medical device.

Instead, this document focuses on demonstrating that the modified CD HORIZON® Spinal System is substantially equivalent to existing, legally marketed predicate devices. The "acceptance criteria" here are met by showing that the modified device has the same indications, intended use, fundamental scientific technology, materials, and sterilization method as the predicates, and that design modifications do not introduce new issues of safety or effectiveness.

Here's an analysis based on the provided document, addressing your points where applicable:

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

Since this is a 510(k) for a spinal implant system aiming for substantial equivalence to predicates, the "acceptance criteria" are not performance metrics like sensitivity, specificity, or AUC as one might find for an AI device. Instead, they relate to material properties, design equivalency, and safety.

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

Not applicable. This is a 510(k) for an updated spinal implant system, not an AI/software device that requires a test set of data. The "test" consists of analytical methods (risk analysis, engineering rationales, material equivalency) rather than performance on a data set.

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 document does not describe a study involving expert review for ground truth establishment.

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

Not applicable, as there is no "test set" in the context of an AI/software device performance study.

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 document is for a spinal implant, not an AI-assisted diagnostic or therapeutic device.

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

Not applicable. This document describes an updated spinal implant system, not a standalone algorithm.

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

Not applicable. The "ground truth" for this submission is whether the modified device remains functionally and materially equivalent to its predicates, which is established through engineering analysis and comparison to existing regulatory clearances, rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable. This is not an AI/machine learning device.

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The CD HORIZON® Spinal System without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to following indications: degeneralive discase (defined as back pain of discogenic origin with degencration of the disc confirmed by history and radios); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis (i.e., scoliosis, kyphosis and/or lordosis); turnor, pseudarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative discase, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforcementioned 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 serew lixation in pediatic patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scollosis, Additionally, the CD HORIZON® Spinal System is intended to treat patients diagnosed with the following conditions: spondylolistlesss / spondylolysis and fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or all. Pediatric pedicle screw lixation is limited to a posterior approach.

The CD HORIZON® SPIREIM Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T)-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: degenerative disease (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.

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. Similarly 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.

Certain components within the CD HORIZON® Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, Shape Memory Alloy Staples, SPIRE™ Plates and DYNALOK® bolts. All screws used in pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromiummolybdenum alloy.

Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System in non-pediatric cases. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples, washers, GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK® PLUS and DYNALOK CLASSIC® bolts along with rod/bolt connectors; and Medtronic Multi-Axial rods and screws. Please note that certain components are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters. Care should be taken so that the correct components are used in the spinal construct.

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

The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium alloy, medical grade cobalt-chromiummolybdenum alloy, or medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite.

The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium alloy, and cobaltchromium-molybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients.

PEEK OPTIMA-LT1 implants may be used with stainless steel, titanium, or cobalt-chromiummolybdenum alloy implants. CD HORIZON® PEEK Rods are not to be used with CROSSLINK® Plates or in pediatric patients.

The purpose of this 510(k) is to add additional sterile rods to the CD HORIZON® Spinal System.

The subject rods, along with other components such as metal screws, hooks and other connecting components, are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of thoracic, lumbar, and/or sacral spine. The subject rods are manufactured out of Commercially Pure (CP) Titanium.

This document is a 510(k) summary for the CD HORIZON® Spinal System, specifically addressing the addition of sterile rods. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a premarket notification for substantial equivalence, not a performance study report.

Therefore, I cannot provide the requested information from the given text.

The document primarily focuses on:

• Device Description: What the CD HORIZON® Spinal System is composed of.
• Indications for Use: The medical conditions for which the device is intended.
• Technological Characteristics: How the device is similar to its predicate.
• Substantial Equivalence: The argument that the new sterile rods are substantially equivalent to previously cleared versions and predicates.
• Non-Clinical Testing: A mention of a sterilization assessment and shelf-life rationale, which are part of establishing substantial equivalence rather than proving specific performance acceptance criteria for a novel device function.

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