(49 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 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 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 alloy or Cobalt Chrome alloy, 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 document is a 510(k) premarket notification for the Orthofix Centurion POCT System, which is a spinal fixation system. It expands the indications for use of an existing device (K131833) to include the use of posterior screws in the cervical region of the spine.
Here's the breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document does not specify quantified acceptance criteria (e.g., specific tensile strength values, fatigue limits). Instead, the performance assessment relies on demonstrating equivalence to predicate devices through mechanical testing standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance in accordance with ASTM F1717 (Static/Dynamic Compression Bending) | Testing conducted per ASTM F1717 demonstrates substantial equivalence. |
| Mechanical performance in accordance with ASTM F2706 (Static/Dynamic Torsion) | Testing conducted per ASTM F2706 demonstrates substantial equivalence. |
| No new safety or effectiveness questions compared to predicate device | The addition of posterior cervical screws does not raise new types of safety and effectiveness questions (risks) not seen before. The same risks occur as in the predicate device. |
| Similar technological characteristics to predicate devices | Similar design, dimensions, intended use, materials, and performance characteristics to predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document mentions "mechanical testing" and "published literature". It does not specify a human "test set" or explicit sample sizes for the mechanical tests themselves.
- Sample Size: Not explicitly stated for specific tests, but implicitly refers to the number of test articles (implants) tested to meet the ASTM standards.
- Data Provenance: The document does not specify the country of origin. It relies on "mechanical testing per ASTM F1717 & F2706" and "published literature". These are laboratory tests, not data from human subjects. The data is likely prospective in the sense that the tests were performed specifically for this submission, although the standards themselves are established.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable. This submission is for a spinal implant fixed via mechanical testing, not a diagnostic or prognostic device requiring expert interpretation of human data.
4. Adjudication Method for the Test Set:
- Not applicable. No human test set or adjudication process is described.
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 mechanical spinal implant, 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 is a physical device, not an algorithm.
7. The Type of Ground Truth Used:
- Mechanical Testing Standards: The "ground truth" for the device's performance is its ability to meet the established mechanical testing criteria outlined in ASTM F1717 and ASTM F2706. These standards define the acceptable mechanical properties (e.g., static and dynamic strength, torsion resistance) for spinal implant assemblies.
- Predicate Device Equivalence: The ultimate ground truth for this 510(k) submission is substantial equivalence to the legally marketed predicate devices, meaning it performs as safely and effectively as a device already on the market.
8. The Sample Size for the Training Set:
- Not applicable. This is a physical device submission based on mechanical testing and predicate device comparison, not an AI or machine learning model that would require a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As above, there is no training set for this type of device submission.
§ 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.