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510(k) Data Aggregation
(63 days)
The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation 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.
When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® cannulated screws are intended 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; pseudoarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
The CD HORIZON® SPINOUS PROCESS Plate is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 – S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: 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); 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 rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.
The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The CD HORIZON® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.
Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK PLUS® bolts; and Medtronic Sofamor Danek Multi-Axial rods and screws.
CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and screws are intended for anterior use only. However, for patients of smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.
The purpose of this 510(k) submission is to include modified multi axial screws to the CD HORIZON® Spinal System.
The provided document is a 510(k) summary for the CD HORIZON® Spinal System, a medical device. It describes the device, its indications for use, and states that it was found "substantially equivalent" to previously cleared devices.
Critically, this document does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics. 510(k) submissions for spinal fixation systems typically rely on demonstrating substantial equivalence to a predicate device, which involves comparing design, materials, indications for use, and often performing mechanical testing to ensure the device meets established engineering standards for strength, fatigue, and other biomechanical properties. However, these biomechanical tests are usually not included in the public 510(k) summary provided, nor do they typically report "device performance" in the clinical sense of diagnostic accuracy, sensitivity, or specificity.
Therefore, many of the requested fields cannot be filled directly from the provided text because these types of studies (e.g., those involving ground truth, expert readers, multi-reader multi-case studies, or standalone algorithm performance) are not applicable to the information presented in this 510(k) summary for a spinal implant.
Here's an attempt to answer as much as possible based on the provided text, while also noting what is not present:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Type of Performance) | Reported Device Performance |
|---|---|
| Clinical Performance (e.g., diagnostic accuracy, sensitivity, specificity) | Not applicable/Not reported in this 510(k) summary. The device is a spinal implant, not a diagnostic tool. Performance for such devices is typically evaluated through substantial equivalence to predicate devices, material testing, and biomechanical testing (e.g., fatigue, static strength), which are referenced but not detailed here. |
| Substantial Equivalence to Predicate Device | Documentation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to CD HORIZON® Spinal System components previously cleared in K042025 and K011508. |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable/Not reported for clinical performance. This 510(k) summary does not describe a "test set" of clinical data (e.g., images or patient outcomes) in the way a diagnostic algorithm would. Substantial equivalence is based on comparison to predicate devices and potentially non-clinical (e.g., mechanical) testing.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There is no "ground truth" establishment described in the context of clinical performance data for this device in this document, as it's a spinal implant, not a diagnostic or screening tool.
4. Adjudication Method for the Test Set
- Not applicable. No test set or adjudication method for clinical performance is described.
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. An MRMC comparative effectiveness study is not relevant for this type of device (spinal implant) and is not mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. For a spinal implant, "ground truth" in the sense of clinical performance metrics isn't established as it would be for a diagnostic device. The "truth" for substantial equivalence often relates to material properties, design specifications, and biomechanical performance meeting predetermined standards, as demonstrated by non-clinical testing.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/algorithm-based device. No training set is described.
9. How the Ground Truth for the Training Set was Established
- Not applicable. No training set or ground truth for it is described.
Summary of the Study (as described in the 510(k) submission):
The "study" described in this 510(k) summary is the process of demonstrating Substantial Equivalence to legally marketed predicate devices. This is the primary regulatory pathway for many Class II and some Class III medical devices.
- Device: CD HORIZON® Spinal System (modified multi-axial screws are the subject of this specific 510(k)).
- Methodology: The submission provided documentation to FDA demonstrating that the CD HORIZON® Spinal System, including the newly proposed modified multi-axial screws, is substantially equivalent in terms of materials, design, technological characteristics, and intended use to previously cleared CD HORIZON® Spinal System components (specifically referencing K042025 and K011508). This implies that the new components meet the same performance standards and have the same intended use as the previously cleared predicate devices. While not explicitly detailed in this summary, demonstrating substantial equivalence for spinal implants typically involves:
- Comparison of indications for use.
- Comparison of design features and materials.
- Mechanical testing (e.g., static and fatigue testing) to demonstrate that the new component's performance is equivalent to or better than the predicate device and meets international standards (e.g., ASTM or ISO standards for spinal implants).
- Biocompatibility assessments of materials.
- Outcome: The FDA reviewed the submission and determined that the device is "substantially equivalent" to the predicate devices for the stated indications for use, thereby allowing it to be legally marketed.
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(78 days)
The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation 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.
When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended 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; pseudoarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 – S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: 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); 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 rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.
The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The CD HORIZON® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® System can be connected to the VERTEX™ Reconstruction System through a rod connector.
Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK PLUS® bolts; and Medtronic Sofamor Danek Multi-Axial rods and screws.
CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and screws are intended for anterior use only. However, for patients of smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.
The purpose of this 510(k) submission is to include additional screws to the CD HORIZON® Spinal System.
This document is a 510(k) premarket notification for the CD HORIZON® Spinal System. It asserts substantial equivalence to previously cleared devices. The document does not describe a study involving a device meeting acceptance criteria in the manner typically associated with AI/medical imaging device submissions (e.g., performance metrics, clinical trials).
Instead, it's a submission for a spinal implant system with the purpose of including "additional screws." The "acceptance criteria" here refer to regulatory acceptance for market clearance based on substantial equivalence, rather than performance criteria from a clinical trial or algorithm validation.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission.
Here's an interpretation based on the information provided, tailored to the type of device and submission:
1. Table of "Acceptance Criteria" (Regulatory) and Reported Device "Performance" (Substantial Equivalence Claim)
| Criteria Category | Specific Criteria / Claim | Reported "Performance" / Evidence |
|---|---|---|
| Regulatory Acceptance | Substantial Equivalence to predicate devices. | Documents demonstrated substantial equivalence to similar CD HORIZON® Spinal System components previously cleared in K042025 (SE 8/25/04) and K000094 (SE 02/08/00). |
| Intended Use/Indications | Device is for posterior, non-cervical fixation for specific spinal conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, failed previous fusion). | The current submission adds screws to the existing system, which maintains the previously cleared indications for use. Specific indications for anterior use and supplementary fixation via the SPIRE Plate are also reiterated. |
| Device Design/Components | Integrates with existing CD HORIZON® System components and other Medtronic Sofamor Danek spinal systems (TSRH®, GDLH®, LIBERTY®, DYNALOK PLUS®). | The new screws are intended to be part of the CD HORIZON® Spinal System, implying compatibility and integration with established components. |
2. Sample size used for the test set and the data provenance
Not Applicable. This submission is for additional components (screws) to an existing spinal system, asserting substantial equivalence based on prior clearances, not a performance study that would involve a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. See point 2.
4. Adjudication method for the test set
Not Applicable. See point 2.
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 submission for a mechanical spinal implant system, not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a submission for a mechanical spinal implant system, with no algorithm or standalone performance testing mentioned or relevant.
7. The type of ground truth used
Not Applicable. The "ground truth" in this context is regulatory acceptance and the established safety and effectiveness of the predicate devices for their indicated uses, which the current device is asserted to be substantially equivalent to. This is based on mechanical testing and clinical experience with the predicate devices, not on data "ground truth" as one would evaluate an AI model.
8. The sample size for the training set
Not Applicable. This is not an AI device or a study involving a training set of data.
9. How the ground truth for the training set was established
Not Applicable. See point 8.
Ask a specific question about this device
(22 days)
The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined by back pain of discogenic origin with degeneration of the disc confirmed by patient 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.
When used in a percutaneous. non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended for the following indications: degenerative disc disease (defined by back pain of discogenic origin with degeneration of the disc confirmed by patient 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, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease--defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; spondylolisthesis; trauma (i.e., fracture or dislocation); 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 rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.
The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The CD HORIZON® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.
Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK PLUS® bolts; and Medtronic Sofamor Danek Multi-Axial rods and screws.
CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and screws are intended for anterior use only. However, for patients of smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.
The purpose of this 510(k) submission is to add modified CD HORIZON® SEXTANT instruments to the CD HORIZON® Spinal System.
The provided text is a 510(k) premarket notification for the CD HORIZON® Spinal System. This document describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way you've outlined for an AI/algorithm-based device.
Here's why and what's missing:
- Device Type: The CD HORIZON® Spinal System is a physical spinal implant (rods, hooks, screws, plates, etc.). It's not an AI or algorithm-based diagnostic or assistive device that would have performance metrics like sensitivity, specificity, or AUC based on processing data.
- Regulatory Pathway: A 510(k) submission demonstrates substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate, often through material testing, mechanical testing, and sometimes bench or animal studies, not clinical studies demonstrating diagnostic accuracy or algorithmic performance against ground truth.
- Lack of Performance Data: The document focuses on product description, indications for use, and a declaration of substantial equivalence to previously cleared devices (K001255 and K001066). There are no sections detailing clinical studies with quantifiable performance metrics, sample sizes for test sets, expert ground truth establishment, or any of the other criteria you listed for an AI study.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies based on the provided text. The requested information is pertinent to AI/machine learning device evaluations, which is not the subject of this 510(k) submission for a physical spinal implant system.
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(28 days)
The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation 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.
When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended for the following in 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; pseudoarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 -- S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: 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); 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 rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.
The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The CD HORIZON® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.
Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors: LIBERTY® rods and screws: DYNALOK PLUS® bolts; and Medtronic Sofamor Danek Multi-Axial rods and screws.
CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and screws are intended for anterior use only. However, for patients of smaller stature. CD HORIZON® 4.5mm rods and associated components may be used posteriorly.
The purpose of this 510(k) submission is to include modified CD HORIZON® hooks to the CD HORIZON® Spinal System.
The provided document is a 510(k) summary for the CD HORIZON® Spinal System from August 2004. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than providing extensive clinical study data with acceptance criteria and performance metrics in the way a PMA submission might.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific device performance against those criteria, sample sizes for test/training sets, expert qualifications, or adjudication methods for a study proving the device meets acceptance criteria.
The core of this 510(k) is the assertion that the modified CD HORIZON® hooks are substantially equivalent to previously cleared CD HORIZON® Spinal System components.
Here's an attempt to address the points based only on the provided text, highlighting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document does not define specific acceptance criteria regarding performance metrics (e.g., strength, durability, biological response) for the modified hooks, nor does it report quantitative performance against such criteria in a study. The "performance" being demonstrated is primarily substantial equivalence in design and intended use to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a clinical or preclinical "test set" with a specified sample size for proving performance against acceptance criteria. The submission is based on demonstrating substantial equivalence through design comparisons and existing predicate device data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This type of information would be relevant for studies evaluating diagnostic or prognostic devices where expert consensus is needed to establish ground truth. This document pertains to a spinal implant system where ground truth would relate to material properties, biomechanical performance, and clinical outcomes, which are not detailed in this summary.
4. Adjudication Method for the Test Set
Not applicable. As no specific test set or expert evaluation is detailed for performance against acceptance criteria, an adjudication method is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are typically used to evaluate diagnostic imaging devices or software. This document is for a spinal implant system.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This document is for a physical medical device (spinal implant), not a software algorithm.
7. Type of Ground Truth Used
Not applicable. For a spinal implant, "ground truth" would typically relate to the physical properties of the materials, the biomechanical stability of the construct, and ultimately, clinical safety and effectiveness. However, no specific studies detailing these "ground truths" and the device's performance against them are presented in this 510(k) summary. The submission relies on the concept of substantial equivalence, meaning it's similar enough to devices already deemed safe and effective.
8. Sample Size for the Training Set
Not applicable. This document does not refer to a "training set" as it would be understood in the context of machine learning or deep learning model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As no training set is described (see point 8), the establishment of its "ground truth" is also not discussed.
Summary of the Study Discussed in the Document:
The primary "study" or justification presented in this 510(k) summary is a demonstration of substantial equivalence of the modified CD HORIZON® hooks to previously cleared predicate devices.
- Evidence presented: "Documentation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to CD HORIZON® Spinal System components previously cleared in K041460 and K031655."
- Approval: The FDA reviewed this documentation and concluded that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."
This means the submission relies on the safety and effectiveness profile of existing, cleared devices rather than providing new, comprehensive performance data for the specific modification.
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(26 days)
The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation 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.
When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended 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; pseudoarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: 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); 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 rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.
The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The CD HORIZON® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.
Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK PLUS® bolts; and Medtronic Sofamor Danek Multi-Axial rods and screws.
CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and screws are intended for anterior use only. However, for patients of smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.
The purpose of this 510(k) submission is to include additional 6.35mm titanium components to the CD HORIZON® Spinal System.
The provided document is a 510(k) premarket notification for a medical device, the CD HORIZON® Spinal System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics.
Therefore, the document does not contain any information about acceptance criteria, reported device performance, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, adjudication methods, or MRMC studies.
The section "Substantial Equivalence VI." explicitly states: "Documentation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to itself." This means the submission is for a modification to an already cleared device, and the method of proving safety and effectiveness is by showing that the modified device is substantially equivalent to the original device.
As such, I cannot populate the requested tables and information based on the provided text.
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