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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 (DDD - 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), tumor, pseudarthrosis, and or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.

With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediativ indications noted.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ System is intended to treat pediatic 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. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. Devices are intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

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: DDD, spondylolisthesis, trauma, and/or tumor.

To achieve additional levels of fixation, CD Horizon™M 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 Vertex™ indications

The PASS LP™ Spinal System is a pedicle screw fixation system intended for immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates and caps for sacral plates, when non-cervical pedicle screw fixation in pediatric patients, the PASS LP™ Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LP™ 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 Spinal System and PASS LP™ Spinal System (including UNiD™ Patient Specific Rods) consist of a variety of shapes and size of rods, hooks, screws, crosslink, plates, staples and connecting components, as well as implants 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.

The purposes of this submission are to:

• Add the UNiD™ Patient Specific Rods (new diameter 4.75mm) to the previously cleared CD Horizon™ Spinal System (K113174, cleared 11/21/2011) and PASS LP™ Spinal System (K140738, cleared 11/04/2014)
• Change the propriety Trade Name from "PASS LP™ Patient Specific Rods" to "UNiD™ Patient י Specific Rods"

UNiD™ Patient Specific Rods are manufactured in titanium alloy Ti-6AI-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, or in cobalt chrome alloy Co-Cr28Mo6 conforming to ISO 5832-12 specifications and ASTM F1537 specifications.

UNiD™ Patient Specific Rods are differentiated in two subgroups: UNiD™ Patient Specific Standard Rods (UNiD ROD) and UNiD™ Patient Specific Percutaneous Rods (UNiD™ Patient Specific Rods have been designed and manufactured for one specific patient. UNiD™ Patient Specific Rods must be used during surgery for this patient only and must not be reused (single use only). The UNiD™ Patient Specific Rods 4.75 diameter rods are not compatible with the PASS LP system. For a complete guide to the system, it is important to refer to the surgical technique.

Please find the information regarding the acceptance criteria and study for the device below.

The provided text is a 510(k) Summary for the CD Horizon™ Spinal System and PASS LP™ Spinal System, which are pedicle screw fixation systems. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, particularly for UNiD™ Patient Specific Rods. The primary purpose of this submission is to add UNiD™ Patient Specific Rods (new diameter 4.75mm) and to change the proprietary Trade Name from "PASS LP™ Patient Specific Rods" to "UNiD™ Patient Specific Rods."

The testing conducted is for mechanical equivalence, not clinical performance or diagnostic accuracy. Therefore, concepts like sensitivity, specificity, accuracy, and reader studies (MRMC, standalone algorithm performance) are not applicable to this type of device submission. The acceptance criteria and "performance" here refer to mechanical strength and durability.

Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (implantable spinal system), the acceptance criteria are based on mechanical properties as per a recognized standard. The document does not provide specific numerical acceptance criteria (e.g., minimum load values) but rather states that testing was conducted in accordance with a standard and demonstrated mechanical equivalence.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. Mechanical testing typically involves a sufficient number of samples (e.g., typically n=5 or n=6 per test condition for medical device mechanical testing) to provide statistically significant results according to the chosen standard (ASTM F1717-18).
• Data Provenance: The testing was conducted by Medicrea (Medtronic). It's scientific/engineering test data, not patient data, so 'country of origin' of data or 'retrospective/prospective' doesn't apply in the common clinical sense. The manufacturer is based in France.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. Ground truth for mechanical testing is established by recognized engineering standards (ASTM F1717-18) and measured physical properties, not expert consensus.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is mechanical testing data, not human-interpreted data. Results are quantified using laboratory equipment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. This type of study is for evaluating the impact of a diagnostic or assistive AI device on human reader performance. This submission is for an implantable medical device, not a diagnostic or AI-driven system.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Standalone Study Done: No. This also refers to AI algorithm performance, which is not relevant to this mechanical device submission.

7. Type of Ground Truth Used

• Type of Ground Truth: Engineering standards and measurements of mechanical properties. The "ground truth" is adherence to established, validated mechanical test methods (ASTM F1717-18) that ensure the device is "substantially equivalent" in performance to predicate devices.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This concept applies to machine learning models. The manufacturing process of UNiD™ Patient Specific Rods involves patient-specific design (i.e., custom bending for one specific patient based on their anatomy), but this is not an AI "training set."

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable. No "training set" in the machine learning sense is used here. For the patient-specific rods, the "ground truth" for each rod's design is the specific patient's anatomical requirements, which are determined via medical imaging and planning, not a training set.

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