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The InterPlate™ IFD is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.

The InterPlate™ C and CGC Systems are intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment.

The InterPlate™ L and LGC Systems are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to SI, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

The InterPlate™ System consists of plates, bone screws and screw covers. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size.

The provided document is a 510(k) summary for the InterPlate™ Interbody Fusion Device. It outlines the device description, intended use, materials, and claims of substantial equivalence to previously cleared devices.

However, the document is a regulatory submission for a medical device (an implantable spinal fusion system), not an AI/Software as a Medical Device (SaMD). As such, it does not contain the type of information requested about acceptance criteria, study data, ground truth, or expert involvement that would be relevant for an AI/SaMD product.

Medical devices like the InterPlate™ are evaluated based on their mechanical properties, biocompatibility, and clinical performance (e.g., fusion rates, complication rates) typically through bench testing, in vitro studies, animal studies, and sometimes human clinical trials, which are different from the SaMD-specific criteria you've listed.

Therefore, I cannot extract the requested information from this document because it is not applicable to the type of product described.

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