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The Dakota ALIF System 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 Dakota ALIF 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. 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 with autogenous bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device. The Dakota ALIF System is a stand-alone system intended to be used with the bone screws provided. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system that has been cleared by the FDA for use in the lumbar spine.

The Dakota ALIF System consists of cages in various widths, heights, and lordoses to accommodate individual patient anatomy and graft material size and bone screws. The devices are intended to provide mechanical support to the implanted level until biologic fusion is achieved. The Dakota ALIF System cages are medical grade PEEK (per ASTM F2026) with tantalum (per ASTM F560) markers and titanium alloy Ti-6Al-4V (per ASTM F136 or ISO 5832-3) integrated fixation screws and screw backout prevention plates. The cages are provided non-sterile.

I'm sorry, but the provided text from the FDA 510(k) clearance letter for the Dakota ALIF System does not contain the specific information required to address your request.

The document is a regulatory clearance letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions performance data related to mechanical testing of the implant (e.g., static and dynamic axial compression, compression shear, subsidence, screw-backout testing) to show that the implant's strength is sufficient for its intended use.

However, it does not include information about:

1. Acceptance criteria and reported device performance (in a table) that would typically be associated with an AI/ML medical device. This device is a physical intervertebral body fusion device, not an AI/ML-driven diagnostic or therapeutic tool.
2. Sample size used for a test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details, as these concepts are relevant to the validation of AI/ML algorithms, not to the mechanical testing of a surgical implant.

Therefore, I cannot fulfill your request for these specific details based on the provided text.

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