(272 days)
Synthes OC Fusion System is intended to provide stabilization to promote fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System and the Synthes Axon System.
Synthes OC Fusion System is indicated for the following:
- Degenerative disc disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal Stenosis
- Fracture/Dislocation
- Atlanto/axial fracture with instability
- Occipital-cervical dislocation
- Revision of previous cervical spine surgery
- Tumors (primary and metastatic)
The use of screws is limited to placement in the occiput. Screws are not intended to be placed in the cervical spine.
The Synthes OC Fusion System consists of occipital plates, occipital screws, occipital clamps, and rods intended to provide stabilization to promote fusion of the occipital-cervical junction. This system allows an occipital-cervical construct of either the occipital plate and rods or occipital clamps and rods. Rods are connected to the occipital plate or occipital clamps using a locking screw. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System and the Synthes Axon System.
The occipital bone screws are available in 4.5mm and 5.0mm diameters in lengths from 4mm to 18mm. Variable angle screw insertion is possible.
The occipital clamps are available in either a one-hole or two-hole configuration. The occipital plate is available in two sizes in either a medial or lateral configuration for a total of four available plates.
The plates are manufactured from commercially pure Titanium, grade 4. The rod connection points (rod clamps) in the plate are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) as are the occipital clamps, rods, and occipital screws.
The provided text describes the 510(k) summary for the Synthes OC Fusion System, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data (bench testing), rather than clinical studies or the use of AI. Therefore, many of the requested categories related to AI performance, clinical trials, and ground truth establishment are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (K982322) in design, function, material, and intended use. | Non-Clinical Performance: Bench testing results demonstrated that the Synthes OC Fusion System is substantially equivalent to the predicate devices. |
| (No explicit numerical acceptance criteria for performance metrics were stated in this summary.) |
Study Proving Device Meets Acceptance Criteria:
A non-clinical performance study (bench testing) was conducted to demonstrate substantial equivalence. The document states: "Bench testing results demonstrate that the Synthes OC Fusion System is substantially equivalent to the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given 510(k) summary. The document focuses on bench testing, not a clinical test set with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable/not provided. The device approval is based on non-clinical bench testing, not on clinical data requiring expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods are relevant for clinical studies involving human assessments, which were not part of this submission for substantial equivalence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is a physical implant, not an AI-powered diagnostic or assistive tool, and the submission did not include clinical studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical implant, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance was established through engineering specifications and performance standards applicable to spinal fixation systems, as evaluated via bench testing against the predicate device. It was not based on expert consensus, pathology, or outcomes data in a clinical trial.
8. The Sample Size for the Training Set
This information is not applicable/not provided. There is no mention of a "training set" as this is not an AI/machine learning device. The design and manufacturing processes follow established engineering principles and quality system regulations.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided. As there is no AI training set, there is no ground truth established for it. The "ground truth" in the context of this device's development would relate to validated engineering principles and material properties used in its design and manufacturing.
§ 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.