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The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.

The MectaLIF 3D Metal are a line extension to the MectaLIF Oblique and Posterior PEEK implants (K110927, K131671, K181970 and K212831) and MectaLIF Oblique and Posterior TiPEEK implants (K133192, K181970 and K212831). Specifically, the purpose of this submission is to obtain the clearance of MectaLIF 3D Metal Posterior, Oblique and Oblique Dome additively manufactured from Ti6Al4V according to ASTM F2924-14. MectaLIF implants are used to replace a degenerative disc in order to restore the height of the spinal column structure. The devices are not intended to be coupled with other implants but are intended to be used with supplemental fixation and autogenous bone graft. The subject implants are provided individually packed, sterile and single-use.

This document is an FDA 510(k) clearance letter for a medical device called "MectaLIF 3D Metal." This type of document is a regulatory submission demonstrating that a new device is as safe and effective as a legally marketed predicate device. It does not generally contain acceptance criteria or detailed study results for AI/software-as-a-medical-device (SaMD), as it pertains to a physical implant.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from the provided text because it is not relevant to this type of device or submission.

The document details the following for a physical medical device (intervertebral body fusion device):

• Device Name: MectaLIF 3D Metal
• Regulation Number: 21 CFR 888.3080
• Regulation Name: Intervertebral Body Fusion Device
• Regulatory Class: Class II
• Product Code: MAX
• Indications for Use: The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion.
• Predicate Devices: MectaLIF Extension (K212831), MectaLIF Posterior Extension (K181970), MectaLIF TiPEEK (K133192), MectaLIF Extension (K131671), MectaLIF (K110927).
• References Devices: Mpact 3D Metal Implants – DMLS Technology (K202568), GMK 3D Metal Tibial Tray (K221850).
• Performance Data (Non-Clinical Studies): Mechanical standard tests (static and dynamic axial/shear compression, axial compressive subsidence), expulsion test, wear analysis, stereological evaluation, abrasion test, static tensile test, static shear test, pyrogenicity testing, biocompatibility assessment, and shelf-life evaluation. These tests are conducted according to various ASTM and ISO standards for intervertebral body fusion devices and implant materials.
• Clinical Studies: No clinical studies were conducted for this submission, as is often the case for 510(k) clearances when substantial equivalence can be demonstrated through non-clinical testing and comparison to predicates.

In summary, the provided text does not contain information about acceptance criteria or performance studies related to AI/software, as it describes the 510(k) clearance for a physical orthopedic implant.

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