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510(k) Data Aggregation
(25 days)
CD HORIZON(R) SPINAL SYSTEM
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion 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.
Except for hooks, when used as an anterolateral thoracic/Jumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.
With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® 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 specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pedialric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. These devices are to be used with autografi. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HO!LIZON® SPIRE™ Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-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 VERTIEX® 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 pediatic 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. CD HORIZON® SPIRE™ spinous process plate devices, Shape Memory Alloy Staples, 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 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 03.5mm. 04.5mm. 05.5mm rods or 06.35mm rods, while other components can connect to both Ø5.5mm rods and Ø6.35mm rods. 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, titanium alloy, medical grade cobaltchromium-molybdenum alloy, or medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite.
Never use stainless steel and titanium implant components in the same construct.
Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromiummolybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct.
The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt-chromium-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 cobaltchromium-molybdenum 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 SOLERA™ multi-axial screws manufactured out of cobalt chrome, titanium alloy and commercially pure titanium and coated with hydroxyapatite to the CD HORIZON® Spinal System for use with 4.75mm diameter rods.
This is a 510(k) premarket notification for a medical device (CD HORIZON® Spinal System), not a study evaluating a device's performance against detailed acceptance criteria in the way a diagnostic AI would be evaluated. Therefore, most of the requested information (like performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies) is not applicable or cannot be extracted from this type of document.
The document describes the submission of a modified version of an existing spinal system and asserts substantial equivalence to previously cleared predicate devices. The "acceptance criteria" here implicitly refer to meeting the FDA's requirements for demonstrating substantial equivalence for a 510(k) clearance, primarily through non-clinical testing for mechanical properties and comparison of materials and indications for use.
Here's an attempt to answer the questions based on the provided text, while also noting where information is not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Equivalence: The modified device (screws with HA coating) must demonstrate mechanical properties equivalent to predicate devices. | "Non-clinical testing in the form of design verification and validation activities was performed on the subject devices to show equivalence to the previously listed predicate devices." |
| Material Equivalence: The HA coating must be identical to previously cleared HA coated devices. | "Testing was not required on the coating since it is identical to the previously listed predicate HA coated devices." |
| Indications for Use Equivalence: The indications for use should be substantially equivalent to predicate devices. | The document explicitly states the indications for use, which are consistent with existing spinal fixation systems. The FDA clearance letter confirms substantial equivalence. |
| Safety and Effectiveness Equivalence: The overall design and materials must be substantially equivalent to predicates, implying similar safety and effectiveness profile. | "Based on the results and additional supporting documentation provided in this premarket notification, the subject devices demonstrated substantial equivalence to the previously listed predicate devices." |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable in the context of this 510(k) premarket notification. This document describes mechanical testing and a comparison to predicate devices, not a clinical study on human subjects with test sets and training sets. The "test set" would refer to the mechanical samples tested.
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)
This information is not applicable. Ground truth, in the sense of expert consensus on clinical data, is not established for this type of submission. The "ground truth" for mechanical testing would be the engineering specifications and performance benchmarks derived from predicate devices, verified by engineers.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically for clinical outcome assessments or diagnostic readings, not for mechanical device testing.
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
This information is not applicable. This submission is for a spinal implant system, not an AI or diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an AI or algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" would be established engineering standards, material specifications, and the performance characteristics of the predicate devices. The study aimed to demonstrate that the new device's mechanical properties and material composition conformed to these established benchmarks.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of this 510(k) submission for a mechanical spinal implant.
9. How the ground truth for the training set was established
This information is not applicable. As above, there is no training set mentioned or implied in this submission type.
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(64 days)
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion 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 fusjon.
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 disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.
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. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis, trauma; and/or tumor.
In order to achieve additional levels of fixation as an adjunct to fusion, 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.
Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washer, 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 3.5mm, 4.5mm, 5.5mm rods or 6.35mm rods, while other components can connect to both 5.5mm rods and 6.35mm rods. 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, 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, titanium alloy, medical grade cobalt-chromium-molybdenum alloy, or medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite. No warranties express, or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog for further information about warranties and limitations of liability
Never use stainless steel and titanium implant components in the same construct.
Medical grade titanium, titanium alloy and/or medical grade cobaltchromium-molybdenum alloy may be used together. Never use titanium, titanium alloy and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct.
The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy and cobalt-chromiummolybdenum alloy. Do not use with stainless steel.
PEEK OPTIMA-LT1 implants may be used with stainless steel, titanium or cobalt-chromium-molybdenum alloy implants. CD HORIZON® PEEK Rods are not to be used with CROSSLINK® Plates.
To achieve best results, do not use any of the CD HORIZON® Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic and neurosurgical implants, none of the CD HORIZON® Spinal System components should ever be reused under any circumstances.
This is a 510(k) premarket notification for a spinal system, which falls under the category of medical devices. The provided document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, not clinical studies involving human or AI performance. Therefore, many of the requested criteria regarding human readers, AI, and clinical ground truth are not applicable to this type of submission.
Here's a breakdown of the applicable information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing: | Passes Mechanical Testing: |
| Axial grip (per ASTM F1798) | The devices were subjected to axial grip testing per ASTM F1798 and passed. |
| Axial torsion (per ASTM F1798) | The devices were subjected to axial torsion testing per ASTM F1798 and passed. |
| Construct static compression bending (per ASTM F1717) | The devices were subjected to construct static compression bending per ASTM F1717 and passed. |
| Construct static torsion (per ASTM F1717) | The devices were subjected to construct static torsion per ASTM F1717 and passed. |
| Construct compression fatigue mechanical testing (per ASTM F1717) | The devices were subjected to construct compression fatigue mechanical testing per ASTM F1717 and passed. |
| Equivalence to Predicate Devices: | Equivalent to Predicate Devices: |
| Substantial equivalence to CD HORIZON® Spinal System (K981676, K040962, K050981, K090390) | The subject components are equivalent to the predicate CD HORIZON® Spinal System and TSRH® Spinal System components. |
| Substantial equivalence to TSRH® Spinal System (K052144) | The subject components are equivalent to the predicate CD HORIZON® Spinal System and TSRH® Spinal System components. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document does not specify a distinct "sample size" for a clinical test set as this is a mechanical testing submission. The "samples" would be the actual spinal system components tested. The number of components tested for each mechanical test is not explicitly stated but would be part of the standard testing requirements for ASTM F1798 and F1717.
- Data Provenance: Not applicable in the context of a clinical study. The testing was mechanical, performed to ASTM standards. The location of the testing is not specified, but it would typically be conducted in a laboratory.
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. Ground truth in this context is established by the successful completion of standardized mechanical tests, not by expert interpretation of clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. There is no adjudication method for a clinical test set in this mechanical testing submission.
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 510(k) submission for a spinal implant system based on mechanical equivalence, not an AI-powered diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the mechanical tests, the "ground truth" is defined by the pass/fail criteria established within the referenced ASTM standards (F1798 and F1717). The components either meet the specified mechanical performance thresholds or they do not.
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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