(79 days)
The intended use of the Certex Spinal Fixation System is to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3):
- · Traumatic spinal fractures and/or traumatic dislocations;
- Instability or deformity;
- · Failed previous fusions (e.g., pseudoarthrosis);
- · Tumors involving the cervical/thoracic spine; and
· Degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The X-spine Certex Spinal Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The X-spine Certex Spinal Fixation System can be linked to X-spine Fortex® Pedicle Screw System and X-spine Xpress™ Minimally Invasive Pedicle Screw System with rod-to-rod connectors and transition rods.
The Certex Spinal Fixation System consists of polyaxial screws, hooks, rods, occipital plates, occipital bone screws, cross bar connectors, lateral offset connectors and rod-to-rod connectors. System components can be connected and locked together to promote fusion of the occipitocervico-thoracic spine (Occiput-T3). System components are offered in various sizes and configurations to accommodate variations in pathology and individual patient anatomy. All Certex Spinal Fixation System components are manufactured from Titanium alloy (Ti6AI4V) in accordance with ASTM F136.
The purpose of this submission is to expand the indications of the Certex Spinal Fixation System to include cervical pedicle screw indications.
The provided document is a 510(k) premarket notification for the "Certex Spinal Fixation System." It focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner typically seen for new AI/medical software devices.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI/software device cannot be extracted from this document, as it is for a mechanical spinal fixation system.
However, I can extract the information related to the performance testing that was conducted for this mechanical device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (indirectly stated) | Reported Device Performance |
|---|---|
| Mechanical soundness equivalent to predicate devices | Met acceptance criteria defined by predicate device performance in static compression, static torsion, dynamic compression, and dynamic torsion. |
2. Sample size used for the test set and the data provenance: Not applicable. This document describes mechanical testing of a physical device, not a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineered standards and measurements, not expert consensus on medical images or outcomes.
4. Adjudication method for the test set: Not applicable.
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 is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/software device.
7. The type of ground truth used: For mechanical testing, the "ground truth" would be the established engineering standards (ASTM F1717, ASTM F2706, ASTM F1798) and the performance characteristics of the predicate devices.
8. The sample size for the training set: Not applicable. This document does not describe a training set in the context of an AI/software device.
9. How the ground truth for the training set was established: Not applicable.
Additional Information from the document regarding the mechanical testing:
- Performance Testing: "Performance testing and a detailed literature search indicates the Certex Spinal Fixation System is as mechanically sound as predicate devices. Testing included static compression, static torsion, dynamic compression, and dynamic torsion per a modified version of ASTM F1717, ASTM F2706 and sub-assembly testing in ASTM F1798. The results demonstrate that the acceptance criteria defined by predicate device performance were met."
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.