(118 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; pseudarthosis; 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 treat adolescent idiopathic scoliosis. The CD HORIZON® Pediatric Spinal System is intended 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 (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 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, 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 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.
The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi).
The purpose of this 510(k) submission is to provide alternative surgical techniques for the CD HORIZON® SPIRETM Spinous Process Plate. The CD HORIZON® SPIRE™ plate is a posterior, non-pedicle supplemental fixation device intended for use in the noncervical spine (TI-S1) as an adjunct to fusion. Specifically, this device is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion.
The provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.
This document is a 510(k) summary for the CD HORIZON® Spinal System, which is a premarket notification to the FDA to demonstrate substantial equivalence to a previously legally marketed device (predicate device).
Here's how the information typically requested in your prompt relates to a 510(k) and why it's largely absent:
- Substantial Equivalence: For a 510(k), the primary "acceptance criterion" is often that the new device is "substantially equivalent" to predicate devices, meaning it has the same intended use and similar technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness.
- "Study that proves the device meets the acceptance criteria": In a 510(k) for devices like spinal systems, this usually doesn't involve clinical performance studies with specific metrics like sensitivity/specificity or human reader improvement with AI. Instead, it relies on:
- Bench testing: To ensure mechanical properties (strength, fatigue, etc.) meet established standards or are comparable to predicate devices.
- Biocompatibility testing: To ensure materials are safe for implantation.
- Sterilization validation: To ensure the device can be properly sterilized.
- Predicate device comparison: The core of a 510(k) is demonstrating that the new device is as safe and effective as a device already on the market (the predicate).
Based on the provided text, I can extract the following relevant information regarding the "study" for this 510(k):
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A table of acceptance criteria and the reported device performance:
- No such table is provided. The submission focuses on demonstrating substantial equivalence to predicate devices, not on meeting specific, quantified performance criteria for a novel AI or diagnostic device.
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Sample size used for the test set and the data provenance:
- Not applicable. There is no "test set" in the context of clinical data for performance evaluation described here. The "study" largely consists of comparing the device to predicates and referencing existing surgical techniques.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This type of expert review to establish ground truth is characteristic of diagnostic performance studies, which are not detailed in this 510(k) summary.
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Adjudication method:
- Not applicable.
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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:
- Not applicable. This is not an AI-assisted diagnostic device. The device is a physical spinal implant system.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used:
- No "ground truth" in the diagnostic sense is mentioned. The basis for safety and effectiveness is largely comparison to predicate devices and "published surgical techniques for devices similar to the subject CD HORIZON® SPIRE™ device."
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The sample size for the training set:
- Not applicable. There's no training set for an algorithm described.
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How the ground truth for the training set was established:
- Not applicable.
Key information that is present regarding the "proof" for this 510(k):
- Supporting Documentation (page 2, section V.I.): "Published surgical techniques for devices similar to the subject CD HORIZON® SPIRE™ device were provided in support of this application. These predicate devices were cleared by the FDA for the same indications and implanted using the techniques noted in this application. The original clearances for these predicate devices were based upon their similarities to the original CD HORIZON® SPIRE™ device. No changes were made to the existing devices. Therefore, no additional testing was required or performed."
- Substantial Equivalence (page 2, section VII.): "The design features, material and indications for use of the CD HORIZON® SPIRE™ Plate are substantially equivalent to the LANX ASPEN Interspinous Anchor cleared in K090252 (SE 03/04/09) and K071877 (SE 09/17/07) as well as the NuVasive AFFIX device cleared in K073278 (SE 03/28/08)."
In summary: The "study" for this 510(k) is a comparison to predicate devices and a declaration of substantial equivalence, relying on the prior clearance of similar devices and the fact that no changes were made to the existing devices, thus obviating the need for novel performance testing.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.