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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 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, 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® System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) 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: spondylolisthesis/ 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 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 purpose of this submission is to modify Medtronic's CD HORIZON® Spinal System to add additional components to the system, specifically non-sterile 30° and 45° Transverse Hooks.

The provided document is a 510(k) premarket notification for the Medtronic CD HORIZON® Spinal System, specifically for the addition of new 30° and 45° Transverse Hooks. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than rigorously proving the device meets acceptance criteria through extensive clinical studies as one might find for novel device approvals.

Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, and multi-reader multi-case studies is largely not applicable nor present in this document, as the submission method (510(k)) and the nature of the device (an modification to an existing spinal system component) do not typically require such detailed clinical performance data.

However, I can extract the information that is present concerning the demonstration of substantial equivalence which serves the purpose of regulatory acceptance for this type of device.

Here's the closest interpretation of your requests based on the provided text:

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission, "acceptance criteria" primarily refers to demonstrating equivalent technological characteristics and performance compared to existing predicate devices, rather than predefined clinical performance metrics. The "reported device performance" is framed in terms of this equivalence.

2. Sample size used for the test set and the data provenance

• Sample size for the test set: Not applicable/Not provided in the context of this 510(k) submission. No clinical "test set" in the traditional sense was used. The evaluation was primarily based on engineering rationale, risk analysis, and comparison to existing mechanical testing data from predicate devices.
• Data provenance: Not applicable/Not provided. The data is internal engineering and risk analysis documentation from Medtronic Sofamor Danek USA, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No "ground truth" was established by experts in the context of clinical data for this type of submission. The safety and effectiveness are established through demonstrating substantial equivalence to predicate devices, supported by internal engineering/risk assessments.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical "test set" requiring adjudication.

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 mechanical spinal implant component, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a mechanical spinal implant component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" equivalent in a 510(k) for a device component like this is the established safety and effectiveness of the predicate devices and the physical/mechanical properties of the materials and design, confirmed through engineering rationale and risk analysis. The regulatory acceptance depends on demonstrating that the new components are equally safe and effective as the predicates.

8. The sample size for the training set

Not applicable/Not provided. There was no "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

Not applicable. There was no "training set" or "ground truth" in this context.

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The Spineology Fortress™ Pedicle Screw System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative discase (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; pseudoarthrosis; and/or failed previous fusion.

The Spineology Fortress™ Pedicle Screw System consists of screws (titanium) and rods (cobalt chrome) to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The devices are provided sterile or non-sterile. The associated instruments are provided non-sterile.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what would typically be found in a medical device submission for performance:

The provided text describes a 510(k) submission for the Spineology Fortress™ Pedicle Screw System, a Class III medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a predicate device, which often involves mechanical testing rather than studies involving human participants or AI performance.

Therefore, many of the requested categories related to AI performance, human readers, ground truth for training data, and clinical study details are not applicable (N/A) to this specific submission.

Acceptance Criteria and Device Performance

The acceptance criteria for the Spineology Fortress™ Pedicle Screw System are established by demonstrating that its mechanical performance is equivalent or superior to the predicate devices when evaluated against recognized ASTM standards. These standards define the expected performance thresholds for pedicle screw systems.

The text states these tests were performed, implying the device met the requirements of the standard for substantial equivalence. Specific quantitative results are not provided in the summary, but in the full submission, these would demonstrate meeting or exceeding predicate device performance. |
| ISO 1798-97(2008) Torsional Grip | "Mechanical testing was performed as follows: flexural grip, torsional grip, and axial grip tests according to F1798-97(2008)"

As above. |
| ISO 1798-97(2008) Axial Grip | "Mechanical testing was performed as follows: flexural grip, torsional grip, and axial grip tests according to F1798-97(2008)"

As above. |
| ASTM F543-13 Axial Pullout | "axial pullout and torque to failure per ASTM F543-13"

The text states these tests were performed, implying the device met the requirements of the standard for substantial equivalence. Specific quantitative results are not provided in the summary. |
| ASTM F543-13 Torque to Failure | "axial pullout and torque to failure per ASTM F543-13"

As above. |
| ASTM F1717-13 Static Torsion | "static torsion and static and dynamic compression bending according to ASTM F1717-13"

The text states these tests were performed, implying the device met the requirements of the standard for substantial equivalence. Specific quantitative results are not provided in the summary. |
| ASTM F1717-13 Static Compression Bending | "static torsion and static and dynamic compression bending according to ASTM F1717-13"

As above. |
| ASTM F1717-13 Dynamic Compression Bending | "static torsion and static and dynamic compression bending according to ASTM F1717-13"

As above. |
| Substantial Equivalence | "The device is shown to be substantially equivalent to the intended use, materials, configuration, and performance characteristics of the predicate products." and "The information submitted in this premarket notification supports a determination that the devices subject to this submission are substantially equivalent in technological characteristics and intended use to the predicate devices."

Overall conclusion based on all testing. |

Study Details (Mechanical Testing)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided summary document. For mechanical testing, sample sizes are typically defined by the relevant ASTM standards to ensure statistical validity (e.g., n=6 for certain tests).
   • Data Provenance: The testing was "performed" by the applicant, Spineology Inc., likely in a laboratory setting. This is not clinical data (e.g., country of origin for clinical data, retrospective/prospective). It refers to in-vitro mechanical testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. Mechanical testing against ASTM standards does not involve "ground truth" derived from expert consensus in the same way clinical or AI studies do. The "ground truth" here is the defined performance requirement within the standard.

3. Adjudication method for the test set:

   • N/A. See point 2. The outcome is determined by adherence to the pass/fail criteria of the ASTM standards.

4. 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. This is a 510(k) for a physical implant (pedicle screw system), not an AI/software device. Therefore, no MRMC study, human readers, or AI assistance is involved.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This is a physical implant.

6. The type of ground truth used:

   • For this type of mechanical testing, the "ground truth" is adherence to the specified performance characteristics and thresholds defined within the referenced ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards (e.g., acceptable flexural strength, pullout force, fatigue life). The comparison is made against predicate devices, demonstrating the new device performs at least as well.

7. The sample size for the training set:

   • N/A. This is mechanical testing of a medical device, not an AI algorithm. There is no concept of a "training set" in this context.

8. How the ground truth for the training set was established:

   • N/A. See point 7.

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