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The MectaLIF Anterior Stand Alone system is an anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The interior of the spacer component of the MectaLIF Anterior Stand Alone can be packed with autograft or autologous bone graft. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The MectaLIF Anterior Stand-Alone system intended to be used with bone screws provided and requires no additional supplementary fixation. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

The MectaLIF Anterior Stand Alone devices are stand-alone anterior interbody fusion devices indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. MectaLIF Anterior Stand Alone is intended to be used with the provided bone screws and requires no additional supplementary fixation.

MectaLIF Anterior Stand Alone consists of disc spacers made of PEEK Implant Grade Polyetheretherketone (ASTM F2026). The spacers are provided uncoated or coated with a commercially pure titanium (CPTi, ASTM F1580) coating. Both uncoated and coated spacers contain tantalum markers (ISO 13782/ASTM F560), and include bone screws made of Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F136), and a plate made of Titanium: Ti6A14V ELI (ISO 5832-3/ASTM F136).

The interior of the disc spacer can be packed with autograft or autologous bone graft. The plate comes in four different designs (Flush, Long, L5-S1, and Hybrid) and is secured to the disc spacer via an interlocking mechanism. The disc spacer and attached plate are secured to the vertebral body with the bone screws. The Flush, Long, and Hybrid plates are used with four bone screws while the L5-S1 plate is used with three bone screws.

The MectaLIF Anterior plates and bone screws were cleared under K124034 and K160605.

The provided text is a 510(k) summary for a medical device called "MectaLIF Anterior Stand Alone." It details the device, its intended use, and its comparison to a predicate device to establish substantial equivalence for regulatory approval.

However, the document does not contain any information about a study involving AI or human readers, or any performance data related to diagnostic accuracy, sensitivity, specificity, or AUC, or any details about ground truth establishment by experts.

Therefore, I cannot fulfill your request for the following information based on the provided text:

• A table of acceptance criteria and the reported device performance: This document does not describe acceptance criteria or performance metrics in the context of an AI-driven or diagnostic study. The "Performance Data" section refers to mechanical testing (static axial compression, dynamic axial compression, etc.) and states that the "subject devices do not represent a new worst case" compared to previously cleared devices. It does not provide numerical results for these tests either, only lists the types of tests.
• Sample size used for the test set and the data provenance: Not present.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
• Adjudication method for the test set: Not present.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present.
• The type of ground truth used: Not applicable in the context of this device's mechanical testing.
• The sample size for the training set: Not applicable as there is no AI training described.
• How the ground truth for the training set was established: Not applicable as there is no AI training described.

In summary, the provided document describes a spinal interbody fusion device that underwent mechanical and material testing for substantial equivalence to a predicate device, not a study involving AI, human readers, or diagnostic performance evaluation.

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