(224 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the Centurion POCT System is indicated for the following :
(a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
(b) spondylolisthesis,
(c) spinal stenosis
(d) trauma (i.e., fracture or dislocation).
(e) Atlanto-axial fracture with instability;
(f) Occipito-cervical dislocation:
(g) Tumors:
(h) Revision of previous cervical spine surgery
The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1 - T3) for anchoring of the OCT construct only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1 - T3). The hooks are intended to be placed from C1 to T3. The cable (titanium) system to be used with the Centurion POCT System allows for wire/cable attachment to the posterior cervical spine.
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, parallel axial connectors, and lateral offset adapters, multi-axial screws, hooks, occipital plates, bone screws, and cables.
The Orthofix Centurion POCT System is a spinal fixation system intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction. The system's acceptance criteria are based on its substantial equivalence to predicate devices, demonstrated primarily through mechanical strength testing as per relevant ASTM standards.
Here's an overview of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Comments |
|---|---|---|---|
| Mechanical Strength | ASTM F2706-08 (Static Axial Compression Bending, Static Torsion) | Demonstrates comparable mechanical and functional properties. | Tested under a vertebrectomy model. |
| ASTM F1798 (Static Axial Gripping Capacity, Static Axial Torque Gripping Capacity, Dynamic Axial Gripping Capacity, Dynamic Axial Torque Gripping Capacity, Static Transverse (y) Mechanical Property Test) | Demonstrates comparable mechanical and functional properties. | Followed Guidance for Industry and FDA Staff Spinal System 510(k)s May 3, 2004. | |
| ASTM F1717 (Static Axial Compression, Static Torsion, Dynamic Axial Compression, Dynamic Torsion) | Demonstrates comparable mechanical and functional properties. | Followed Guidance for Industry and FDA Staff Spinal System 510(k)s May 3, 2004. | |
| Material Equivalence | Commercially pure titanium/titanium alloy with option for cobalt chrome rods. | Subject and predicate devices are made from commercially pure titanium/titanium alloy with the option of titanium/titanium alloy or cobalt chrome rods. | Ensures material compatibility and established biomechanical properties. |
| Intended Use Equivalence | Identical to predicate device. | Intended use is identical to predicate devices. | Ensures the device is appropriate for the same clinical applications. |
| Design Equivalence | Substantially equivalent to predicate devices. | Features of subject components are substantially equivalent to predicate devices. | Relies on structural and functional similarities. |
| Packaging & Sterilization | Identical to predicate device. | Packaging and sterilization of the predicate and subject components are identical. | Ensures safety and efficacy in handling and use. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify exact sample sizes for each mechanical test. However, "Mechanical testing" implies multiple units were tested to demonstrate performance against the specified ASTM standards.
- Data Provenance: The mechanical testing was conducted to support the substantial equivalence claim for the Centurion POCT System. This is typically done prospectively as part of product development and regulatory submission by the manufacturer (Orthofix Inc., a US company). The data would be considered prospective in the context of demonstrating performance for regulatory approval. The country of origin for the data is implicitly the United States as Orthofix Inc. is a US-based sponsor and the submission is to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- This information is not applicable to this type of submission. The "ground truth" for medical device mechanical performance is established by standardized testing protocols (ASTM standards) and engineering principles, not by human expert consensus or clinical pathology. The "experts" are the engineers and testing laboratory personnel who conduct and analyze these mechanical tests, adhering to the specified standards.
4. Adjudication Method for the Test Set:
- This is not applicable to mechanical testing. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving human interpretation or subjective assessments. Mechanical tests yield objective, quantitative results directly comparable to established standards.
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:
- This is not applicable. The device described is a spinal implant for mechanical fixation, not an AI-powered diagnostic or interpretive tool that would involve human readers or image analysis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used:
- For mechanical testing, the "ground truth" is defined by the established performance criteria within the specified ASTM standards and the "Guidance for Industry and FDA Staff Spinal System 510(k)s" document. The device components must meet or exceed these predetermined mechanical thresholds to be considered substantially equivalent and safe/effective. This is an objective, quantitative ground truth.
8. The Sample Size for the Training Set:
- This is not applicable. As a physical implant, this device does not utilize a "training set" in the context of machine learning or AI development. The design and manufacturing processes are informed by engineering principles and prior device knowledge, rather than a data training set.
9. How the Ground Truth for the Training Set was Established:
- This is not applicable for the reasons stated in point 8.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.