Search Results
Found 4 results
510(k) Data Aggregation
(28 days)
The CD HORIZON® Spinal System without SEXTANT® instrumentation is intended for posterior, non-ecryical fixation as an adjunct to fusion for the following indications: degencrative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion,
With the exception of degeneralive discase, the CD HORIZON® LEGACY™ 3,5mm rods and the CD HORUZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3,5mm rods may be used for the indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatic patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolishesis spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.
The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations with each construct being tailormade for the individual case.
A subset of CD HORIZON® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK® Plates and connecting components. Similarly to the CD HORIZON® implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The purpose of this Special 510(k) is the modifications of implants for the CD HORIZON® Spinal System. The modifications to the implants are adding additional sizes of cannulated multi-axial screws (MAS), print updates for a rebaselining of existing closed lateral connectors, and adding additional sizes of SEXTANT® pre-bent rods with different tip geometries and connection types.
This document is a 510(k) Summary for the Medtronic CD HORIZON® Spinal System. It is a premarket notification to the FDA to demonstrate substantial equivalence to previously cleared devices. Therefore, it does not describe a study to prove a device meets acceptance criteria in the typical sense of a clinical trial or performance study for a novel AI/software medical device.
Instead, this document focuses on demonstrating that the modified CD HORIZON® Spinal System is substantially equivalent to existing, legally marketed predicate devices. The "acceptance criteria" here are met by showing that the modified device has the same indications, intended use, fundamental scientific technology, materials, and sterilization method as the predicates, and that design modifications do not introduce new issues of safety or effectiveness.
Here's an analysis based on the provided document, addressing your points where applicable:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a spinal implant system aiming for substantial equivalence to predicates, the "acceptance criteria" are not performance metrics like sensitivity, specificity, or AUC as one might find for an AI device. Instead, they relate to material properties, design equivalency, and safety.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Subject implants are manufactured from identical materials (ASTM F138, F139, F136, F67) as predicate devices. These materials (titanium alloy, commercially pure titanium, medical grade stainless steel) have a long history of safe and effective use in predicate spinal implants. Biocompatibility testing is not required due to this established history and material equivalency. |
| Mechanical Performance | A risk analysis of device modifications was completed. This analysis, including engineering rationales, demonstrated that the subject CD HORIZON® Spinal System implants do not introduce new issues of safety or effectiveness. No additional non-clinical testing was performed because the modifications (additional sizes of cannulated multi-axial screws, print updates for existing closed lateral connectors, and additional sizes of SEXTANT® pre-bent rods) were deemed not to significantly alter the fundamental performance characteristics beyond what was already established for the predicate devices. This implies that the mechanical performance is equivalent to the predicate devices. |
| Indications for Use | Identical to the recently FDA cleared CD HORIZON® Spinal System 510(k) K141494. The modified device shares the same indications as the predicates for adult and pediatric use in various spinal conditions. |
| Intended Use | Same as predicate devices. |
| Fundamental Science/Tech | Same as predicate devices. |
| Materials | Identical to predicate devices (specified ASTM standards). |
| Sterilization Method | Same as predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) for an updated spinal implant system, not an AI/software device that requires a test set of data. The "test" consists of analytical methods (risk analysis, engineering rationales, material equivalency) rather than performance on a data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This document does not describe a study involving expert review for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no "test set" in the context of an AI/software device performance study.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document is for a spinal implant, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes an updated spinal implant system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission is whether the modified device remains functionally and materially equivalent to its predicates, which is established through engineering analysis and comparison to existing regulatory clearances, rather than clinical outcomes or diagnostic accuracy.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
Ask a specific question about this device
(63 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; pseudarthritis; 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 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. 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 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, 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 provided document is a 510(k) summary for the
CD HORIZON® Spinal System. This type of regulatory submission is for a medical device and is not a study that proves a device meets acceptance criteria in the typical sense of a clinical trial or algorithm performance study.
Instead, the document focuses on demonstrating substantial equivalence to previously approved predicate devices, which is the primary requirement for 510(k) clearance. Substantial equivalence means the new device is as safe and effective as a legally marketed device (predicate device).
Therefore, the requested information categories related to acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training sets are not directly applicable to this type of document because it is not a clinical study or an AI/algorithm performance study.
However, I can extract information related to the demonstration of substantial equivalence, which serves a similar purpose in the regulatory context of this device.
Here's a breakdown of the available information in the context of your request:
I. Acceptance Criteria and Device Performance
The "acceptance criteria" in this context are not quantitative performance metrics as in a clinical trial. Instead, the acceptance criterion for a 510(k) submission is to demonstrate substantial equivalence to predicate devices. This is achieved by showing that the new device has "similar technological characteristics" and is "as safe and effective" as the predicate.
The "reported device performance" is not given as numerical results from a clinical study, but rather implied through mechanical testing and risk analysis compared to predicate devices.
| Acceptance Criterion (Regulatory) | Reported "Device Performance" (Demonstration of Substantial Equivalence) |
|---|---|
| Demonstration of Substantial Equivalence (Safety and Effectiveness) to Predicate Devices | "Documentation, including mechanical test results and a risk analysis, was provided which demonstrated that the subject CD HORIZON® Spinal System devices are substantially equivalent to predicate CD HORIZON® Spinal System rods and associated connecting and fixation components (K042025 SE 08/25/04, K030840 SE 05/15/03, K031655 SE 06/27/03. K032265 SE 08/11/03. K033322 SE 12/15/03. K042167 SE 09/08/04. K043488 SE 03/22/05, K050439 SE 03/24/05, K050809 SE 06/14/05, K053474 SE01/09/05. K061579 SE 08/11/06. K061591 SE 09/08/06. K082236 SE 10/10/08. K090390 SE 05/15/09, K091442 SE 07/15/09) and TSRH® Spinal System screws (K052054 SE 08/19/05)." The new components (4.75mm diameter rods and associated connecting and fixation components) are fabricated from "medical grade titanium, titanium alloy and/or grade cobalt-chromium-molybdenum alloy," which are materials used in predicate devices. The indications for use are also largely consistent with those of the predicate devices. |
II. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. This document refers to mechanical testing and risk analysis, not a clinical "test set" of patients or data in the way an AI algorithm study would. The focus is on the new components themselves.
- Data Provenance: The document does not specify country of origin for the mechanical test data. It is a regulatory submission to the US FDA. The "study" is a collection of engineering tests and a risk analysis, not a clinical data study. It is retrospective in the sense that it evaluates new components against established predicate devices and materials.
III. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. This is not a study requiring expert clinical review to establish ground truth. Substantial equivalence is determined by regulatory bodies (FDA) based on submitted engineering data and comparison to predicates.
- Qualifications of Experts: N/A.
IV. Adjudication method for the test set
- Adjudication Method: Not applicable. No clinical test set or subjective interpretations requiring adjudication are mentioned.
V. 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
- MRMC Study: Not applicable. This is a spinal implant system, not an AI diagnostic tool.
VI. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device (spinal implant), not an algorithm.
VII. The type of ground truth used
- Ground Truth Type: Not applicable in the traditional sense of a clinical study. For a medical device 510(k), the "ground truth" for demonstrating safety and effectiveness relies on established engineering principles, material science, biomechanical testing standards, and the history of safe and effective use of the predicate devices.
VIII. The sample size for the training set
- Training Set Sample Size: Not applicable. No training set is relevant for this type of device submission.
IX. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
Ask a specific question about this device
(29 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® 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 5.5mm diameter straight and pre-bent titanium cannulated rods to the CD HORIZON® Spinal System.
This is a 510(k) premarket notification for the CD HORIZON® Spinal System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria and performance studies in the same way a PMA (Premarket Approval) submission would.
Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and study methodologies (like MRMC or standalone performance) is not applicable for this 510(k) summary.
Here's a breakdown of what is available and why other requested details are not present for this type of submission:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. For a 510(k), the "acceptance criteria" is primarily the demonstration of "substantial equivalence" to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness. There are no specific quantitative performance metrics or acceptance criteria for device performance laid out in this document as there would be for a novel device undergoing a PMA.
2. Sample sized used for the test set and the data provenance
- Not Applicable. This document does not detail a "test set" in the context of clinical or performance data collection because it's a 510(k) submission. The substantial equivalence was shown through "Documentation, including a risk analysis, mechanical test reports and a finite element analysis." These are engineering and analytical tests, not clinical performance studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As no clinical "test set" with ground truth was used for this 510(k) submission, there were no experts establishing ground truth in this context.
4. Adjudication method for the test set
- Not Applicable. No clinical test set requiring adjudication was performed or reported in this 510(k) summary.
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 device is a spinal implant system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. As mentioned above, this is a physical medical device, not an algorithm.
7. The type of ground truth used
- Not Applicable. No ground truth in the clinical sense (expert consensus, pathology, outcomes data) was used in this 510(k) submission for performance evaluation. The "truth" established for substantial equivalence was based on engineering analysis and comparison to predicate devices.
8. The sample size for the training set
- Not Applicable. This device is a spinal implant, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
Summary of Substantial Equivalence (the "Study" for 510(k)):
The "study" in a 510(k) context is the demonstration of substantial equivalence.
- Evidence Provided: "Documentation, including a risk analysis, mechanical test reports and a finite element analysis."
- Predicate Devices: The device was deemed substantially equivalent to similar CD HORIZON® Spinal System components previously cleared in K032265 (SE 8/11/03) and in K031655 (SE 06/27/03).
- Data Provenance: The mechanical test reports and finite element analysis would have been generated internally by the manufacturer (Medtronic Sofamor Danek) during the device development process. This is not patient data.
- Ground Truth: The "ground truth" for showing substantial equivalence essentially relies on established engineering principles and comparison to the safety and effectiveness profile of the predicate devices.
Ask a specific question about this device
(64 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® 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 plates and multi-axial screw components to the CD HORIZON® Spinal System.
The provided text is a 510(k) summary for the CD HORIZON® Spinal System. This type of regulatory submission in the U.S. demonstrates substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and a study proving performance is not present in this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not provided. The document focuses on demonstrating substantial equivalence to previously cleared devices (K032265 and K031655) for the purpose of adding new components (plates and multi-axial screws) to an existing system, not on meeting predefined performance criteria through a new study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new study data is presented. The submission relies on the predicate devices' prior clearances.
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. No new study data is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new study data is presented.
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 spinal implant system, not an AI-assisted diagnostic or treatment device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a spinal implant system, not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" in a 510(k) submission like this is primarily the established safety and effectiveness of the predicate device(s) and the demonstration that the new device or components do not raise new questions of safety or effectiveness.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
Summary of available information from the document:
The document, K041777, is a 510(k) premarket notification for the CD HORIZON® Spinal System, specifically for the addition of plates and multi-axial screw components.
- Substantial Equivalence: The primary "proof" in this document is the demonstration of substantial equivalence to previously cleared devices: K032265 (cleared 8/11/03) and K031655 (cleared 06/27/03). This means the manufacturer argued that the new components are as safe and effective as the predicate devices, and perform similarly to the previously cleared versions of the CD HORIZON® Spinal System.
- Intended Use/Indications: The document extensively lists the indications for use for the CD HORIZON® Spinal System, including posterior, non-cervical fixation for conditions like degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and failed previous fusion. It also specifies indications for percutaneous approaches, anterolateral thoracic/lumbar systems (with ECLIPSE® components), and the CD HORIZON® SPIRE Plate.
Ask a specific question about this device
Page 1 of 1