Search Results

The Tiger 2 System is a pedicle screw system intended to provide Immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deform-ities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impair-ment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Tiger 2 System when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degener-ation of the disc confirmed by history and radios), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The Tiger 2 System Fenestrated Screws are intended to be used with saline and radiopaque dye.

The Tiger 2 System is comprised of pedicle screws, rods, hooks, rod connectors and cross connectors. The Tiger 2 System can be used for single or multiple level fixations. The pedicle screws have various options in length and diameters. The rods are available in straight and prelordosed (curved) configurations. The system has variable length cross connectors.

The provided text is a 510(k) summary for the Tiger 2 System, a medical device for spinal fixation. It details the device's indications for use, materials, and mechanical testing results. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/software performance.

The document primarily focuses on the substantial equivalence of the Tiger 2 System to a predicate device based on:

• Mechanical Performance Data: Static and dynamic compression bending, and axial and torsional grip testing were performed according to ASTM F1717 and ASTM F1798.
• Technological Characteristics: Basic design (rod-based fixation system with polyaxial pedicle screws), materials (titanium alloy, cobalt chrome), and intended use.

The "device" in this context is a physical pedicle screw system, not an AI or software-driven device. Therefore, the questions regarding AI/software performance, such as sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable to this document.

In summary, based solely on the provided text, it is not possible to answer the questions about acceptance criteria and study proving device meets acceptance criteria for an AI/software product. The document describes a traditional medical device clearance process focused on mechanical equivalence.

Ask a specific question about this device