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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 ÉLLIPSE® 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 iliac 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 tconnectors 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.

The rods 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. All other CREO™ implants are composed of titanium alloy or stainless steel, as specified in ASTM F136, F1295, F67 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.

Here's a breakdown of the acceptance criteria and the study information for the CREO™ Stabilization System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not mention a test set in the context of clinical data for a pre-market notification. The "Performance Data" section specifically refers to mechanical testing, not patient or image data. Therefore, there is no information on sample size for a test set, data provenance, or retrospective/prospective nature of such a study.

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

This information is not applicable as the submission relies on mechanical testing against established standards and predicate device equivalence, not clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on mechanical performance and substantial equivalence.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable as the device is a physical spinal stabilization system, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Mechanical Testing Standards: Adherence to ASTM F1717.
• FDA Guidance: Compliance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s," May 3, 2004.
• Predicate Device Performance: The underlying assumption is that the predicate devices have established safety and effectiveness.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI model that requires a training set of data.

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

This information is not applicable for the same reasons as #8.

Summary of the Study:

The "study" that proves the CREO™ Stabilization System meets its acceptance criteria is primarily mechanical testing. This testing was conducted in accordance with:

• ASTM F1717: A standard specific to spinal implant mechanics.
• "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s," May 3, 2004: FDA's specific recommendations for spinal system submissions.

The results of this mechanical testing demonstrated "substantial equivalence" to the predicate devices (REVERE® Stabilization System, REVERE® 4.5 Stabilization System, Medtronic CD Horizon® Spinal System, Synthes USS, and DePuy VIPER® 2 System). This equivalence means the CREO™ system is considered to be "as safe, as effective, and perform as well as or better than the predicate device." The study did not involve clinical trials with human subjects or AI algorithm performance evaluations.

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