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The ChoiceSpine TigerShark™ M, Modular Interbody System is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The device system is designed for use with autograft bone and/or allogenic bone grafts composed of cancellous bone grafts, and with supplemental internal fixation systems (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) cleared for use in the lumbosacral spine.

The ChoiceSpine TigerShark™ M, Modular Interbody System, consists of implants with components that are both additively and traditionally manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001, Class C and Ti-6Al-4V ELI per ASTM F136 respectively). The device is provided in lengths of 24-32mm and final heights of 9-17mm with 6° and 12° lordotic options and contains a hollow core to receive autogenous and / or allogenous bone graft.

The provided text is a 510(k) summary for a medical device (ChoiceSpine TigerShark™ M, Modular Interbody System). Such summaries primarily focus on demonstrating substantial equivalence to a predicate device through non-clinical testing (e.g., mechanical, material, biocompatibility) rather than clinical studies evaluating AI-driven performance.

Therefore, the document does not contain the information required to answer the questions regarding acceptance criteria and study that proves the device meets the acceptance criteria for an AI/ML-based device.

The questions you've asked (about sample sizes, data provenance, expert ground truth, MRMC studies, standalone performance, training data, etc.) are highly relevant for the FDA's review of artificial intelligence and machine learning (AI/ML)-enabled medical devices. This document, however, describes a traditional orthopedic implant, an intervertebral body fusion device.

Without information specific to an AI/ML component, I cannot fulfill the request.

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