Search Results

The Genesys Spine Anterior Cervical Plate system is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, and/or spinal stenosis.

The Genesys Spine Anterior Cervical Plate System is indicated for temporary stabilization of the cervical spine during the development of solid spinal fusion. The system consist of multiple sizes (lengths) of plates, and screws that are to be inserted into the anterior surface of adjacent cervical vertebrae. The proposed device is applied after discectomy and insertion of either an autograft material in the interbody space, and acts to stabilize the spine during fusion. The plates are offered in 1, 2, 3, and 4 level constructs in various lengths to accommodate a variety of patient anatomies. Each plate has a pre-bent sagittal and lordotic curve as well as posterior ridges to aid in the placement. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The bone screws are offered in lengths of 10, 12, 14, and 16mm. The screws are offered in a Fixed or Variable angle option. The fixed screw has a larger 'neck' outer diameter that engages with the plate thereby limiting the conical rotation of the screw while the variable screw 'neck' outer diameter which allows for 24 degrees of motion during screw insertion. This feature will allow the surgeon more flexibility when inserting and seating the screws. The screws are offered in four (4) colors based on fixed or variable geometry or 3.75mm or 4.25mm OD. The plates include a nitinol securement tab, preassembled to the plate that covers the heads of the bone screws on the lateral sides to reduce the potential for screw backout. Additionally, there is a ratcheting feature that provides an audible and tactile feel for the surgeon population during insertion.

Here's an analysis of the provided text regarding the Genesys Spine Anterior Cervical Plate System, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) premarket notification for a medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a previously marketed (predicate) device, rather than proving novel clinical efficacy or establishing specific performance metrics against a predefined acceptance criterion in the way a clinical trial for a new drug or a more complex diagnostic algorithm might. Therefore, many of the requested categories (like "effect size of human readers improved with AI," "standalone algorithm performance," "sample size for training set," etc.) are not applicable to this type of device and submission.

Acceptance Criteria and Supporting Study for Genesys Spine Anterior Cervical Plate System

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. The testing was focused on device mechanics rather than patient-specific data or clinical outcomes. The "test set" here refers to the physical constructs tested (e.g., worst-case construct).
• Data Provenance: Not applicable for patient data. The data originates from nonclinical, benchtop mechanical testing performed by or for Genesys Spine.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable. Ground truth for mechanical testing is established by engineering principles, industry standards (like ASTM F1717), and material science, not by expert medical consensus on individual cases.
• Qualifications of Experts: Not applicable. The "experts" would be the engineers and technicians conducting the ASTM F1717 physical testing and FEA.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical test results (e.g., force, displacement, cycles to failure) are objective measurements, not subject to human adjudication in the way clinical diagnoses or image interpretations are.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. This is a mechanical surgical implant, not an imaging or diagnostic AI device that would utilize MRMC studies.
• Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Standalone Study Done: Not applicable. This device does not involve an algorithm, AI, or software for clinical decision-making. The "standalone performance" is the mechanical performance of the physical device itself. The nonclinical testing evaluates the device's mechanical integrity and behavior.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device's "performance" is based on established engineering principles, material science properties, and adherence to recognized industry standards (like ASTM F1717) for spinal implant mechanical testing. The goal is to show that the device performs mechanically at least as well as its predicate devices under specified test conditions.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not use machine learning or AI, and therefore has no "training set."

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

Summary of Device Performance and Equivalence Claim:

The Genesys Spine Anterior Cervical Plate System demonstrated substantial equivalence to its predicate devices (Synthes Anterior CSLP System, Venus Anterior Cervical Plate Systems, Spider Cervical Plating System, Trestle Anterior Cervical Plating System, and SmartLox Anterior Cervical Plate) through a series of nonclinical biomechanical tests. These tests included:

• Static compression bending
• Static torsion
• Dynamic compression bending

All these tests were performed on the "worst-case construct" as per the requirements of ASTM F1717. Additionally, finite element analysis (FEA) and material property analysis, along with design verification results, further supported the claim of substantial equivalence. The document explicitly states that "Clinical data and conclusions were not needed for this device," indicating that the nonclinical data was sufficient for the 510(k) clearance based on substantial equivalence.

Ask a specific question about this device