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The VertiForm Posterior Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients for the following conditions: degenerative disc disease (DDD), DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, curvatures (scoliosis, lordosis), tumor, pseudarthrosis (previous failed fusion). When used as posterior non-cervical pedicle screw fixation in pediatric patients, the VertiForm Posterior Fixation System is intended to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft to facilitate fusion.

The VertiForm Posterior Fixation System is a non-cervical spinal fixation system consisting of pedicle screws, set screws, rods and cross connectors. The pedicle screws are offered in a Polyaxial. Fixed or Uniplanar pedicle screw configuration and are available in a variety of geometries and sizes to accommodate patient anatomy. They are offered non-sterile and sterile. The VertiForm Posterior Fixation System is manufactured from titanium alloy (ASTM F136), medical-grade commercially pure titanium (ASTM F67) and medical-grade cobalt chrome (ASTM F1537). This Special 510(k) Premarket Notification seeks clearance to add variable cross connectors to the currently marketed VertiForm Posterior Fixation System.

The provided document is a 510(k) summary for a medical device called the "VertiForm Posterior Fixation System." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a clinical study or detailed acceptance criteria for an AI/algorithm.

Therefore, the information required to fill out the table and answer the study-related questions (points 1-9) about acceptance criteria, study design, sample sizes, ground truth, experts, and MRMC studies is not present in this document.

Here's why and what information is available:

• Device Type: This is a physical spinal implant system (pedicle screws, rods, cross connectors), not an AI/algorithm-based diagnostic or therapeutic device.
• Regulatory Pathway: A 510(k) submission primarily relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This is often achieved through comparison of indications for use, technological characteristics, and sometimes non-clinical performance testing (e.g., mechanical tests for implants).
• Focus of the Document: The document explicitly states that it seeks clearance to add "variable cross connectors" to an already marketed VertiForm Posterior Fixation System. The main comparison is between the modified device and the predicate device (the previous version of the VertiForm system, K141291).

What is present in the document is a summary of non-clinical (mechanical) testing performed to demonstrate equivalence, not AI performance metrics:

• Non-Clinical Test Summary (Section 5):
  • Dynamic compression testing: Performed in accordance with ASTM F1717, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, 2004."
  • Bacterial endotoxin testing: Performed in accordance with ANSI/AAMI ST72.
  • Results: "Testing results demonstrated that the VertiForm Posterior Fixation System with variable cross connectors performs comparable with the predicate device."

In summary, the request pertains to information typically found in submissions for AI/algorithm-enabled medical devices, which is not applicable to this 510(k) for a spinal implant system.

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