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510(k) Data Aggregation
(94 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 HORIZON® Spinal System mav 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 (T1-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. These components can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case.
A subset of the 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. Crosslinks® 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 introduce modified rods and a rod . inserter into the CD HORIZON® Spinal System.
The provided text is a 510(k) summary for the CD HORIZON® Spinal System and its components. It describes the device, its indications for use, and claims substantial equivalence to previously marketed predicate devices. It discusses non-clinical tests (bench testing and engineering assessments) but does not contain information about studies involving human subjects or AI algorithms.
Therefore, I cannot provide information for most of your requested points, as they pertain to clinical studies, AI performance, ground truth establishment, and expert involvement, which are not present in this document.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify acceptance criteria in terms of specific performance metrics or thresholds for the device itself (e.g., accuracy, sensitivity, specificity). Instead, it relies on the concept of substantial equivalence to predicate devices. The "reported device performance" is essentially that the new components (modified rods and rod inserter) perform similarly to the existing predicate components.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices for rods | The subject rods have the same fundamental scientific technology, identical diameter and length, and are manufactured from the same materials as the predicates (Cobalt-Chromium-Molybdenum and Commercially Pure Titanium). |
| Substantial Equivalence to predicate devices for rod inserter | The subject percutaneous rod inserter has the same fundamental scientific technology and is manufactured from the same materials (stainless steel and silicone) as the predicate. |
| Does not create a new worst case for the overall system | An engineering assessment was conducted, demonstrating that the subject rod inserter is substantially equivalent, and the addition of subject rods does not create a new worst case. |
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. The submission is based on non-clinical tests (engineering assessment, risk analysis, validation labs) and comparison to predicate devices, not human subject 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)
Not applicable. There is no mention of experts establishing ground truth within the context of a clinical study or AI performance evaluation. The "ground truth" for this submission is based on engineering principles, materials science, and established performance of existing predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned as there are no human-read test sets.
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 spinal implant system and instrumentation, not an AI or imaging device that would typically involve MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is based on engineering assessments, materials specifications, and the established performance and safety profiles of predicate devices that have been legally marketed.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" in the context of this device submission.
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