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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")

Detailed Responses to Specific Questions:

1. 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.

2. 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.

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):

   • 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.

4. 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.

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:

   • N/A. This is a physical spinal implant, not an AI or diagnostic tool. MRMC studies are not relevant here.

6. 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.

7. 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).

8. The sample size for the training set:

   • N/A. This is not an AI or machine learning device and therefore has no training set.

9. 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.

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