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The MectaLIF Anterior is an 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 MectaLIF Anterior 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 at least six months of non-operative treatment. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The MectaLIF Anterior Stand-Alone system is intended to be used with bone screws provided and requires no additional supplementary fixation. The MectaLIF Anterior Simple requires additional supplementary fixation such as pedicle screws and rods or lumbar anterior plate system.

The subject MectaLIF Anterior Extension implants are a line extension designed to provide a larger product offering in Medacta MectaLIF Anterior portfolio. The MectaLIF Anterior is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. The family of MectaLIF Anterior system features two designs: MectaLIF Anterior Stand-Alone Fusion Device System, which is a system consisting of cages, plates and is intended to be used with bone screws provided and requires no additional supplementary fixation. MectaLIF Anterior Simple, which is a cage/plate system requiring additional supplementary fixation. The purpose of this submission is to introduce new cages footprints as well as new plates and screws designs. Identically to already cleared MectaLIF Anterior implants, the subject MectaLIF Anterior Extension implants consists of disc spacers made of PEEK Implant Grade Polyetheretherketone (ASTM F2026) body coated with commercially pure titanium (CPT), ASTM F1580). The spacers contain tantalum markers (ISO 13782 / ASTM F560) and include a flush plate secured to the vertebral body with 4 bone screws. Both the plates and the screws are made of Ti6A14V ELI (ISO 5832-3/ASTM F136). The flush plate is secured to the disc spacer via an interlocking mechanism and it is available in two designs lock and lag where an additional anti-back-out cover plate is used to reduce the risk of screw migration after the implantation. The interior of the disc spacer can be packed with autograft or autologous bone graft.

The provided text describes the MectaLIF Anterior Extension, an interbody fusion device. However, it does not include acceptance criteria or the specifics of a study proving the device meets said criteria as would be present for an AI/ML powered device. This document is a 510(k) summary for a medical device that appears to be a physical implant, not an AI or software-based medical device. Therefore, the requested information regarding AI/ML device performance, such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not applicable or available in this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data (e.g., mechanical testing, biocompatibility).

Key Points from the document:

• Device Type: The MectaLIF Anterior Extension is a physical interbody fusion device (implants, plates, and screws).
• Approval Basis: The approval is based on demonstrating substantial equivalence to legally marketed predicate devices, not on proving new clinical effectiveness or AI/ML performance.
• No Clinical Studies: The document explicitly states: "No clinical studies were conducted."
• No AI/ML Component: There is no mention of any AI or machine learning component in the device description or performance data.

Therefore, I cannot provide the requested table or information because it is not within the scope of the provided document. The questions about AI/ML performance metrics are not relevant to this specific device.

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