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When Fortilink-C is used as cervical interbody fusion (IBF) implants, these devices are indicated for use in skeletally mature patients with degenerative disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the cervical spine and are placed via an anterior approach from C2-C3 to C7-T1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) weeks of non-operative treatment with an interbody fusion device.

When Fortilink-TS and Fortilink-L are used as lumbar interbody fusion (IBF) implants, these devices are indicated for intervertebral body fusion of the spine in sketally mature patients with degenerative disc disease (DD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L1-L2 to L5-S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an interbody fusion device.

The interbody fusion (IBF) devices are designed to be inserted into the intervertebral body space of the spine, and are intended for intervertebral body fusion. These implants are manufactured from a radiolucent polymer (PolyEtherKetoneKetone (PEKK)) (ASTM F2820) which should support radiographic imaging inside the implant to evaluate fusion status and are assembled with radiographic markers composed of tantalum (ASTM F560) to facilitate proper implant position. The implants are provided sterile by gamma irradiation and are intended to be used with supplemental fixation cleared for the implanted level. The implants are supplied with instrumentation necessary to facilitate the insertion and removal of the implants, as well as general manual surgical instruments. These implants are provided in different footprints and varying heights to provide implant options best suited to an individual's pathology and anatomical condition. The following designs are included in the Fortilink IBF System : - Fortilink-C IBF System - Fortilink-TS IBF System - Fortilink-L IBF System

The provided text is a 510(k) premarket notification for a medical device, the Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology. It details the device's characteristics, indications for use, and a summary of pre-clinical performance data.

However, the document does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI/human-in-the-loop system. The "Pre-Clinical Performance Data" section lists standard ASTM test methods for intervertebral body fusion devices, such as static and dynamic axial compression, static subsidence, and static expulsion/push-out. It also mentions evaluation for pyrogenicity using the Limulus Amebocyte Lysate (LAL) assay. These are mechanical and biological performance tests for the physical implant, not for an AI-driven or diagnostic system.

Therefore, I cannot populate the table or answer the specific questions related to AI system performance, ground truth, expert consensus, or MRMC studies, as this information is not present in the provided text. The document is for a physical medical implant, not an AI/software as a medical device (SaMD).

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