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The PATHWAY Intervertebral body fusion device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved level(s).

The device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rods systems and anterior screw and rod systems). The device is intended to be used with autogenous bone graft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PATHWAY AVID device.

The PATHWAY AVID Intervertebral body fusion device must be inserted using a transforaminal approach.

The PATHWAY AVID Intervertebral Body Fusion Device is made from PEEK Optima. The device is made from multiple PEEK segments. The segments are serrated on the superior and inferior surfaces. The PEEK segments are attached with titanium pins and have a titanium linkage that attaches the segments. This pins and the linkage provide the means to form into its final articulated shape.

The titanium alloy pins serve as markers providing visual aid in determining the location of the implant both intra and postoperatively.

The articulated device foot print ranges from 8 mm through 14 mm in height, 20mm in width and 35 mm in length.

The implants are non-sterile and instruments are provided clean and non-sterile. These devices are to be sterilized by the user facility.

The provided text describes a medical device, the PATHWAY AVID Intervertebral Body Fusion Device, and its 510(k) summary for FDA clearance. However, the document does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of AI/ML performance.

The "Performance Data" section states: "Performance data per ASTM 2077 and ASTM 2267 and compared to the predicate devices. In addition, cadaver testing demonstrated the PATHWAY AVID is substantially equivalent to its predicates, as it was shown that the device can be used as intended by the intended user population per its labeling following a standard training program."

This indicates physical performance testing and comparison to predicate devices, and cadaver testing for surgical use, but it does not involve any AI/ML components, acceptance criteria tables, or studies with a test set, ground truth experts, or training sets as requested in the prompt.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance from the provided text.

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