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The Choice Spine TiGer Shark™ System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six (6) months of non-operative treatment. This device is designed to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. This device is designed for use with supplemental fixation that is cleared for use in the lumbar spine.

The Choice Spine TiGer Shark™ System consists of implants made of titanium alloy (Ti-6Al-4V ELI per ASTM F3001, Class C). The spacers have a basic rectangular shape, a hollow center for placement of bone graft and a smooth bullet shaped distal surface. They are available in an assortment of height, length and anteroposterior angulation combinations to accommodate many different anatomic requirements. The implants are delivered via a posterior, transforaminal, or lateral approach. The devices are manufactured using the Electron Beam Melting (EBM) additive manufacturing method.

This document is a 510(k) summary for the Choice Spine TiGer Shark™ System, an intervertebral body fusion device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, the requested information (acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC study details, and standalone performance) is not available within the provided text.

The document discusses the following types of non-clinical testing performed:

• Static Compression - Per ASTM F2077
• Static Compression Shear - Per ASTM F2077
• Dynamic Compression - Per ASTM F2077
• Dynamic Compression Shear - Per ASTM F2077
• Expulsion - N/A
• Subsidence - per ASTM F2267

It states that "Mechanical testing was conducted to prove that the new worst-case design is stronger, and after including all other similarities, shown to be equivalent to the predicate devices in safety, effectiveness, and performance." However, it does not specify the acceptance criteria for "stronger" or "equivalent," nor does it present the numerical results of these tests.

In summary, the provided text does not contain the information necessary to complete the requested table and study details.

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