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The CREO® Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and for pediatric patients (CREO® 4.75 only). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When used as an adjunct to fusion, the CREO® Stabilization System is intended to be used with autograft and/or allograft.

In addition, the CREO® Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CREO® 4.75 Stabilization System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The CREO® 4.75 Stabilization System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

In order to achieve additional levels of fixation in skeletally mature patients, the CREO® Stabilization System rods may be connected to the REVERE® Stabilization System (5.5mm or 6.35mm rod), REVERE® 4.5 Stabilization System (4.5mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. In order to achieve additional levels of fixation in pediatric patients, the CREO® Stabilization System rods may be connected to the REVERE® 4.5 Stabilization System using corresponding connectors. Refer to the REVERE®, REVERE® 4.5, or ELLIPSE® system package insert for instructions and indications of use.

The CREO® Stabilization System consists of rods, hooks, monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking caps, t-connectors, head offset connectors, trans-iliac connectors, staples, and associated manual surgical instruments. Implants are available in a variety of sizes to accommodate individual patient anatomy. CREO® implants mate with 4.75mm. 5.5mm. and 6.35mm diameter rods. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and t-connectors are intended for posterior use only. Staples are intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod and trans illac connectors.

The most common use of this screw, hook, and rod system in the posterior thoracolumbar and sacral spine is two rods, each positioned and attached lateral to the spinous process via pedicle screws and/or lamina, pedicle or transverse process hooks.

The most common use of this screw, hook, and rod system in the anterior thoracolumbar spine is one rod, positioned and attached to the vertebral bodies via monoaxial screws through an appropriate size staple.

Screws and hooks attach to the rods using a locking cap with an inner set screw. The size and number of screws are dependent on the length and location of the rod. Screws are inserted into a pedicle of the thoracolumbar and/or sacral spine. Screws may be used with a staple. The type and number of hooks are also dependent on the location in the spine needing correction and/or stabilization. Hooks are attached to the laminae, pedicles, or transverse process of the posterior spine.

T-connectors are modular components designed to connect the two rods of a construct and act as a structural cross member. The rod-clamping set screws secure the t-connectors to the rods. Additional set screws secure the adjustable cross members at the desired length. Additional connectors may be used to connect two rods, and are also secured using set screws.

CREO® Stabilization System S-rods and unit rods are specifically excluded for use in adolescent idiopathic scoliosis patients.

CREO® implants are composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F67, F1537 and F138. Screws are also available with hydroxyapatite (HA) coating per ASTM F1185. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium-molybdenum alloy implants.

This document is a 510(k) premarket notification for the "CREO® Stabilization System"
It is for the purpose of seeking clearance for additional cobalt chrome implants for the system.
Thus, this is NOT a study of whether the system itself meets acceptance criteria but rather for additional components of such system.

Therefore, the requested information cannot be fully provided as the document is a submission for additional implants, not a primary study detailing full device performance for the initial clearance. However, I can extract the information available from the document regarding the justification for the additional implants.

Here's an attempt to answer based on the provided text, recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document describes mechanical testing as part of the performance data.

• Sample Size: Not explicitly stated for specific tests.
• Data Provenance: Not stated (e.g., country of origin, retrospective/prospective). The tests were conducted to support a US FDA 510(k) submission, so it's likely conducted in compliance with US standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable to this type of submission. The performance criteria are based on mechanical and material engineering standards (ASTM F1717 and F1185, FDA Guidance), not clinical ground truth established by medical experts during a study.

4. Adjudication Method for the Test Set

Not applicable. This pertains to clinical studies involving interpretation of data by multiple readers. The evaluation here is based on engineering test results against established standards.

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

No. This document does not mention any MRMC comparative effectiveness study. The submission is for additional implants for an already cleared system, relying on mechanical testing for equivalence.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a spinal fixation device, an implantable medical device, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context refers to established engineering and material standards (ASTM F1717, ASTM F1185, FDA Guidance for Spinal System 510(k)s, May 3, 2004) to which the new implants' mechanical properties are compared. There is no biological/clinical "ground truth" as typically understood in diagnostic device studies.

8. Sample Size for the Training Set

Not applicable. This is not a study involving training data.

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

Not applicable.

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