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UNiD Patient-matched PLIF cage is indicated for lumbar spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels form 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 I Spondylolisthesis or Retrolisthesis at the involved level(s). This device is to be used with bone graff.

UNiD Patient-matched PLIF cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The UNiD patient-matched PLIF cage is an intervertebral lumbar device, designed to match the anatomy of an individual patient from patient imaging data (X-Ray, MRI, CT). The implant is manufactured in titanium alloy (Ti-6Al-4V ELI conforming to ASTM F3001 specifications) from additive manufacturing process.

This looks like a 510(k) summary for a medical device called "UNiD Patient-matched PLIF cage". The provided text describes the device, its intended use, and compares it to predicate devices. It also mentions non-clinical testing but explicitly states that no clinical studies were performed.

Therefore, I cannot provide information regarding acceptance criteria and a study proving the device meets those criteria in the way you've requested, as this submission indicates clinical performance data is not available. This 510(k) relies on substantial equivalence to predicate devices, not on a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.

If you have a different document that details clinical studies and acceptance criteria, please provide that. Otherwise, based only on the provided text, the answer is that no such study was performed to demonstrate performance against acceptance criteria.

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