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510(k) Data Aggregation
(127 days)
The CD HORIZON® Spinal System with or without SEXTANT® intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis); 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 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 pediatic indications noted below.
When used for posterior non-cervical pediatic 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 pediatic patients diagnosed with the following conditions: spondylolysis and fracture caused by tumor and/ or trauma. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CDHORIZON® SPIRE™ Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the noncervical 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 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.
The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium alloy, medical grade cobalt chromium molybdenum alloy, or medical grade PEEK OPTIMA-LTI. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite.
The purpose of this 510(k) is to add additional non-sterile rods to the CD HORIZON® Spinal System. The type of rods includes a series of tapered and straight rods. The subject rods are manufactured out of medical grade cobalt-chromium-molybdenum alloy.
The subject rods along with other components such as metal screws, hooks and other connecting components are intended to help provide immobilization of spinal segments as an adjunct to fusion of thoracic, lumbar, and/or sacral spine.
This document is a 510(k) premarket notification for the CD HORIZON® Spinal System and primarily focuses on establishing substantial equivalence for new, additional non-sterile rods being added to an existing system. It describes mechanical testing performed to demonstrate that these new rods do not introduce new risks and meet predetermined acceptance criteria, thereby making them substantially equivalent to previously cleared predicate devices.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies, adhering to your requested format:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Did it pass?) |
|---|---|
| Performance relative to "predetermined acceptance criteria" for mechanical tests, as per ASTM F1798 and ASTM F1717. | "The subject devices met the pre-determined acceptance criteria for all tests." (Specific numerical values for acceptance criteria or performance are not provided in this document). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact number of test samples (e.g., number of rods tested) for each mechanical test. It only states that "Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices."
- Data Provenance: The data provenance is internal to Medtronic, a U.S.-based company (Memphis, TN). This is a premarket submission to the FDA, indicating it's part of a regulatory approval process conducted by the manufacturer. The testing described is prospective, as it was performed specifically for this 510(k) submission.
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 document describes mechanical testing of a spinal implant. It does not involve human anatomical data, image analysis, or clinical evaluation requiring expert medical interpretation to establish "ground truth." Therefore, this section is not applicable. The "ground truth" here is adherence to engineering standards and predetermined mechanical performance criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As this study is mechanical testing of a medical device against engineering standards, an "adjudication method" in the context of expert review of clinical data (like 2+1 or 3+1) is not applicable. The "adjudication" is determined by whether the test results meet predefined physical and mechanical thresholds outlined in the ASTM standards.
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
No MRMC study was performed. This document relates to the mechanical testing of spinal system components (rods) and not to an AI/imaging device requiring human reader interpretation studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This document is for a physical medical device (spinal rods), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this study is defined by established engineering standards and predetermined acceptance criteria outlined in ASTM F1798 and ASTM F1717. The device passes if its mechanical properties (e.g., static and fatigue properties) meet these specified thresholds.
8. The sample size for the training set
Not Applicable. This document describes mechanical testing for a physical device, not an AI or machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not Applicable. As there is no training set for an AI algorithm, the ground truth establishment method for a training set is not relevant here.
Ask a specific question about this device
(28 days)
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 and/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 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 pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. 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 (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 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 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.
The system also includes various instruments used to assist in the implantation of the system via minimally invasive approaches.
The purpose of this submission is to modify Medtronic's CD HORIZON® Spinal System to add additional lined rods to the system, specifically, 4.75mm lined rods in cobaltchromium-molybdenum alloy.
Here's an analysis of the provided text regarding the CD HORIZON® Spinal System's acceptance criteria and studies:
Analysis of the Provided Text
The provided text (a 510(k) summary) describes an addition of "lined rods" to an existing spinal system. It does not describe a study involving an algorithm, AI, or human readers. Instead, it describes a submission for a traditional medical device (spinal implant components), where the acceptance criteria and supporting "study" are focused on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices through non-clinical testing.
Therefore, many of the requested categories (like AI performance, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone AI performance, etc.) are not applicable to this type of device submission and are not present in the document.
Acceptance Criteria and Device Performance (Based on "Substantial Equivalence")
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as per non-clinical tests) |
|---|---|
| No new risks introduced by the modified device (the additional lined rods). | "Verification and validation activities demonstrated that no new risks have been introduced to CD HORIZON® Spinal System by the addition of the subject lined rods." |
| The modified device does not create a new worst-case scenario for the overall CD HORIZON® Spinal System. | "Verification and validation activities demonstrated... that the addition of the subject lined rods does not create a new worst case for the overall CD HORIZON® Spinal System." |
| The modified device maintains the same fundamental scientific technology as the predicate device. | "The subject CD HORIZON® Spinal System, including the additional lined rods, has the same fundamental scientific technology as the predicate CD HORIZON® Spinal System." |
| The modified device (lined rods) has the same critical dimensions (e.g., diameter, length) as relevant predicate rods. | "Like the predicate CD HORIZON® Spinal System rods, the subject rods are 4.75mm in diameter and are 500mm in length." |
| The modified device is manufactured from the same material specification as the predicate rods. | "The subject rods are manufactured from the same cobalt chromium alloy per ASTM F1537 as the predicate rods." |
| The labeling and indications for use remain substantially equivalent to predicate devices, or changes are justified. | The Indications for Use section outlines the usage for the updated system and is presented in the context of being substantially equivalent to previously cleared devices. The addition of the "lined" feature is noted as a visual aid to the surgeon, not a change in fundamental function or indication. |
| Previously submitted testing for relevant components (e.g., CD HORIZON® LEGACY™ 4.5 devices) remains applicable to the modified device. | "The previously submitted testing for CD HORIZON® LEGACY™ 4.5 devices still applies." (This implies that the new component does not invalidate prior testing, supporting the "no new worst-case" and "no new risk" criteria). |
| A risk analysis of the device modifications was completed in accordance with Medtronic design control procedures. | "A risk analysis of the device modifications was completed in accordance with Medtronic design control procedures." (This is a procedural acceptance criterion, indicating compliance with design control processes). |
| Overall conclusion: The modified device is substantially equivalent to legally marketed predicate devices. | "Therefore, Medtronic believes the subject CD HORIZON® Spinal System, including the subject lined rods, to be substantially equivalent to legally marketed predicate devices, including the predicate CD HORIZON® Spinal System." (FDA's letter confirms agreement with this determination.) |
Detailed Responses to Specific Questions:
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A table of acceptance criteria and the reported device performance:
- See the table above. It is crucial to understand that for a 510(k) submission for a modification to a traditional medical device, "acceptance criteria" are not typically quantitative performance metrics like sensitivity/specificity. Instead, they are around proving "substantial equivalence" to a predicate device, which involves demonstrating that the new device is as safe and effective as the predicate without introducing new questions of safety or effectiveness. This is primarily done through non-clinical (bench) testing, material comparisons, and analysis of design changes.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This submission focuses on non-clinical (bench) testing of physical components. There is no "test set" of patient data in the context of an algorithm or diagnostic device. The evaluation is based on material properties, dimensional comparisons, and mechanical testing of the rods themselves. No patient data (country of origin, retrospective/prospective) is involved.
-
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):
- N/A. Ground truth, in the context of expert consensus, is not relevant for this type of device. The "truth" for this device modification is established through engineering and material science principles, comparing the new component to existing, cleared components.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are typically associated with human reviewer disagreements in diagnostic or AI studies. This is a submission for physical device components based on non-clinical testing.
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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:
- N/A. This is a physical spinal implant, not an AI or diagnostic tool. MRMC studies are not relevant here.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device has no algorithm. It is a physical implant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the device itself: The "ground truth" or standard for safety and effectiveness is established by the performance and safety profile of the legally marketed predicate devices (CD HORIZON® Spinal System K131321, K091974, K042025). The non-clinical tests demonstrate that the modified device performs equivalently to these predicates in terms of mechanical properties and material composition. There is no "ground truth" in the diagnostic sense (e.g., pathology report).
-
The sample size for the training set:
- N/A. This is not an AI or machine learning device and therefore has no training set.
-
How the ground truth for the training set was established:
- N/A. As there is no training set, this question is not applicable.
In summary: The provided document is a 510(k) summary for a minor modification (adding lined rods) to an existing spinal implant system. The "study" involves non-clinical (bench) testing and analysis to demonstrate that the new component is substantially equivalent to previously cleared components, without introducing new safety or effectiveness concerns. It does not pertain to AI, algorithms, or studies involving patient data or human readers in the way these questions are posed.
Ask a specific question about this device
(112 days)
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/lumbar system, the CD HORLZON® 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 scollosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis and fractures caused by tumor and/or trauma. These devices are to be used with autograft and/or allograft. 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 (TI-SI) 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 IV. 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, SPIRETM Plate 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-chromium-molybdenum 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 and 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 $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 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. 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 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.
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 neurosureical implants, none of the CD HORIZON® Spinal System components should ever be reused under any circumstances.
The purpose of this 510(k) submission is to expand the pediatric indications of the CD HORIZON® Spinal System to include spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma.
The provided text is a 510(k) Summary for the CD HORIZON® Spinal System and clarifies an earlier substantial equivalence letter. It describes the device, its components, intended use, and indications, particularly an expansion of pediatric indications. However, it does not contain information about specific "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of performance metrics for an AI/ML medical device.
Instead, the document states:
- "Supporting Documentation: Published retrospective clinical data for the CD HORIZON® Spinal System as well as devices similar to the subject spinal system were provided in support of this application. This clinical data demonstrated pedicle screws posed no new risks to pediatric patients. No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed."
This indicates that the submission relies on existing clinical data and the substantial equivalence to previously cleared devices. It explicitly states that "no additional testing was required or performed" for this specific submission, as it was primarily for expanding indications of an existing system.
Therefore, for the specific questions requested, the answer is that this document does not contain the information needed to fill out such a table or provide details on performance studies for an AI/ML component. The device is a physical spinal system, not an AI/ML diagnostic or predictive tool, so performance metrics like sensitivity, specificity, or reader improvement with AI assistance are not applicable.
Based on the provided text, the following information is either not applicable or not present:
- A table of acceptance criteria and the reported device performance: Not provided. The submission relies on prior clearances and existing clinical data for the predicate device.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not explicitly stated for this submission's purposes. It mentions "Published retrospective clinical data" but does not detail the sample size or provenance.
- 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, as this is a physical implant, not a diagnostic device requiring ground truth from experts for performance evaluation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is a physical medical device, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The document refers to "clinical data" demonstrating "pedicle screws posed no new risks to pediatric patients," implying reliance on patient outcomes and safety data from previous studies.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Ask a specific question about this device
(500 days)
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 discase (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic sudies); 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/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 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. The CD HORIZON® Pediatric Spinal System is intended to be used with autograft and/or allografi. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON SPIRE™ Plate is a posterior, 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 Meduronic 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 HORZON® 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, DYNALOK® bolts, TSRH® screws and washers. 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 cobaltchromium-molybdenum 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 and 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 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 anterios 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.
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.
The purpose of this 510(k) submission is to expand the indications of use to allow for use of pedicle screw based constructs to treat pediatric patients.
The provided text is a 510(k) summary for the CD HORIZON® Spinal System, focusing on expanding its indications for use in pediatric patients. It does not describe an AI medical device or a study proving its performance against acceptance criteria in the manner typically seen for AI/ML devices.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable to this document.
However, I can extract information related to the device's intended use and the "clinical assessment" provided in support of its expanded indication.
Here's the breakdown based on the provided text, noting where information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
This document describes a medical device, not an AI algorithm. It does not provide explicit acceptance criteria in terms of performance metrics (like sensitivity, specificity, or AUC) that would be evaluated by a study, nor does it report device performance in that way. Instead, it refers to the collection of clinical data to support the expanded indication.
| Acceptance Criteria (Not explicitly stated for performance, but implied clinical safety and effectiveness) | Reported Device Performance (Clinical Data Summary) |
|---|---|
| Implied: Demonstrate safety and effectiveness for pediatric pedicle screw fixation in adolescent idiopathic scoliosis, consistent with existing similar devices and clinical practice. | Published clinical data from: |
- More than 600 pediatric patients treated with pedicle screw constructs alone.
- More than 900 patients treated with a hybrid construct (pedicle screws and hooks). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not explicitly detailed in the 510(k) summary for a "test set" in the context of an AI device. The document mentions "Published clinical data of pediatric patients" but does not specify the design (retrospective/prospective) or country of origin.
- Sample Size: "More than 600 pediatric patients treated with pedicle screw constructs alone" and "more than 900 patients treated with a hybrid construct." (Total >1500 pediatric patients). This is referred to as clinical data supporting the expanded indication, not a "test set."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It is referred to as "Published clinical data."
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 is not applicable as the document describes a spinal implant system, not a device requiring ground truth established by experts in an AI context. The "ground truth" would be the clinical outcomes and diagnoses of the patients, established by treating clinicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The document refers to clinical patient data and outcomes, not an adjudication process for labeling an AI test set.
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 is not applicable. The device is a spinal implant system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as it is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical data provided, the "ground truth" implicitly refers to the clinical outcomes and diagnoses of the pediatric patients treated for adolescent idiopathic scoliosis, as determined by their treating physicians. This would encompass aspects like the initial diagnosis, surgical success, fusion rates, complication rates, and long-term functional outcomes, which are standard for clinical studies of medical devices.
8. The sample size for the training set
This is not applicable as it is not an AI algorithm.
9. How the ground truth for the training set was established
This is not applicable as it is not an AI algorithm.
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