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ABTross ALIF Expandable Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. ABTross ALIF Expandable Cage System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six months of non-operative treatment with a lumbar intervertebral fusion device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>=20° lordosis) must be used with at least anterior supplemental fixation.

The ABTross ALIF Expandable Cage System is interbody fusion devices. This cage system is made of Titanium 6AL-4V Alloy (ASTM F136). And cages are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The cage can be expanded in height using the system instrument after being inserted in the unexpanded state. The cages have serrations on the superior endplate and inferior endplate surfaces area to contact vertebrae bone endplate. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g., posterior pedicle screw and rod systems, anterior or lateral plate systems, and anterior screw and rod systems). All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances.

The provided text describes the regulatory filing for the ABTross ALIF Expandable Cage System, a medical device for spinal fusion. It details the device's indications for use, materials, and comparative analysis with predicate devices. However, the document does not contain the specific information requested regarding acceptance criteria for a device performance, the study that proves it meets those criteria, or details related to AI/MRMC studies.

The document focuses on demonstrating substantial equivalence to existing devices cleared by the FDA, primarily through bench testing of mechanical properties. It does not present clinical study data or performance metrics in the format of acceptance criteria.

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, or AI/MRMC study results, as this information is not present in the provided text.

The text does mention:

• Performance Data: "Performance testing was performed to demonstrate that the subject ABTross ALIF Expandable Cage System is substantially equivalent to other predicate devices."
• Tests Conducted: Static compression, dynamic compression, static and dynamic shear testing according to ASTM F2077, static expulsion test (ASTM draft F-04.25.02.02), and static subsidence test (ASTM F 2267-04).
• Result of Tests: "Bench testing to evaluate the mechanical properties of the ABTross ALIF Expandable Cage System showed a higher or similar mechanical value than predicate marketed devices."
• Ground Truth Type: Not explicitly stated, but the "higher or similar mechanical value" suggests that the "ground truth" for the mechanical tests would be the established acceptable mechanical properties or performance of the predicate devices according to the ASTM standards.
• Training Set Sample Size/Ground Truth: This information is not applicable and hence not provided as the evaluation is based on mechanical bench testing against predicate performance, not a machine learning model.

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