(19 days)
The Centurion POCT System is intended 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 fraumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Centurion POCT 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 Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.
The Centurion POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of Titanium allov or Cobalt Chrome allov, that allow the surgeon to build a spinal implant construct. The Centurion POCT System consists of an assortment of rods, set screws, cross connectors, parallel and axial connectors, lateral offset adapters, multi-axial screws, hooks, occipital plates, bone screws, and cables.
This FDA 510(k) K180025 submission describes a modification to an existing device, the Centurion POCT System, specifically a design change to the set screw component of the cross connector to include a retention feature. It is a Special 510(k) submission, meaning it relies on previously established substantial equivalence and focuses on the impact of the modification.
Therefore, the submission does not contain a new study to prove the device meets acceptance criteria in the traditional sense of a clinical trial or a performance study to establish new clinical efficacy or safety. Instead, the focus is on demonstrating that the modification does not negatively impact the device's performance compared to its predicate device, which was already cleared.
Here's a breakdown of the requested information based on the provided document, much of which will be listed as "Not Applicable" for this type of submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance (Static) | |
| Axial Gripping Capacity (per ASTM F1798-13) | Performed (details of specific values not provided in this summary, but implies successful completion comparing modified design to predicate) |
| Transverse Mechanical Property (per ASTM F1798-13) | Performed (details of specific values not provided in this summary, but implies successful completion comparing modified design to predicate) |
| Technological Characteristics | |
| Design, Dimensions, Intended Use, Materials, and Performance Characteristics | The Centurion POCT System will continue to utilize the technological characteristics in terms of design, dimensions, intended use, materials, and performance characteristics (as the predicate device). There is no significant difference between the predicate device which would adversely affect the use of the product. |
| The Centurion POCT System will continue to utilize the same intended use, indications for use, technological characteristics and design, same materials and the same principles of operation as previously cleared under K150822. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document. For static mechanical testing, the "sample size" would typically refer to the number of test articles (modified set screws/cross connectors) tested to meet the ASTM F1798-13 standard.
- Data Provenance: Not specified, but generally, such engineering tests are conducted in a laboratory environment, likely within the manufacturer's R&D or QA facilities, or third-party testing labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. This submission details engineering performance, not interpretative medical decisions. Ground truth in this context is based on physical measurements and compliance with engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is an engineering verification of a physical device component, not a diagnostic or interpretative study.
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 spinal fixation system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a spinal fixation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering Standards: The "ground truth" for the mechanical testing is defined by the requirements and methodologies outlined in the ASTM F1798-13 standard ("Standard Test Method for Static and Fatigue Bending Properties of a Spinal Rod with Transverse Connectors"). Compliance with these standardized performance metrics constitutes the ground truth for this type of evaluation.
8. The sample size for the training set
- Not Applicable. This is a physical device modification, not a machine learning model.
9. How the ground truth for the training set was established
- Not Applicable. This is a physical device modification, not a machine learning model.
§ 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.