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The HD LifeSciences Cervical IBFD System is indicated for use anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at a single level from C2 to T1. Patients should have received 6 weeks of nonoperative treatment prior to treatment with the device is indicated to be used with allograft bone comprised of cancellous and/or corticocancellous bone. The HD LifeSciences Cervical IBFD System requires additional supplemental fixation cleared for the cervical spine.

The HD LifeSciences Cervical IBFD System consists of interbody fusion cages made from Ti-6Al-4V implant-grade titanium using additive manufacturing technology. The titanium takes the form of a highly porous core which is surrounded at the cephalad and caudal ends by protective solid titanium endplates. The implant is anatomic in shape and has teeth to ensure placement is maintained after implantation.

The provided text describes a medical device, the HD LifeSciences Cervical IBFD System, and its substantial equivalence to predicate devices, focusing on its mechanical performance. However, it does not include information on acceptance criteria for a study, reported device performance metrics in relation to those criteria, or details regarding study design, sample sizes, expert involvement, or ground truth establishment.

Therefore, I cannot provide the requested information based on the provided text. The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence through technological characteristics and performance testing against industry standards for mechanical strength, rather than a clinical study evaluating diagnostic or treatment efficacy.

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