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The KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis 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. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The KLIMT Expandable LIF Cage System is a lumbar intervertebral fusion cage that is implanted in the disc space between the intervertebral bodies to obtain fusion and mechanical stability. The subject cage is vertically expandable i.e., it has a height adjustable feature for ease of implantation and final secure fit to a patient's anatomy. The cage's components are manufactured via Selective Laser Melting (SLM) 3D printing technology using a medical grade metal powder and/or by machining (CNC method) and assembled into a final cage unit. The cages are manufactured from titanium alloy powder per ASTM F3001 and titanium alloy per ASTM F136 and are provided both sterile and nonsterile to the end user. The patient contacting portion of all instruments is made from Stainless Steel per ASTM F899 and all instruments are provided non-sterile and intended to be sterilized by the end user prior to use.

The provided text describes a medical device, the KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System, and its clearance process with the FDA. It does not describe acceptance criteria for a software device or a study proving that a device meets such criteria.

The information provided is for a physical medical device (an intervertebral body fusion device), not a software or AI-driven system. Therefore, I cannot extract the requested information about acceptance criteria for a software device, test set details, ground truth establishment, MRMC studies, or training set specifics, as these concepts are not applicable to the document's content.

The document discusses non-clinical performance data for the physical cage system, primarily focusing on mechanical testing (e.g., static and dynamic compression bending, torsion, subsidence, expulsion) as per ASTM standards, to demonstrate substantial equivalence to predicate devices. There are no clinical tests reported ("O N/A").

The "Summary of Performance Data (Nonclinical and/or Clinical)" section explicitly states:

• Non-Clinical Tests:
  • Static Compression Bending (per ASTM F2077)
  • Dynamic Compression Bending (per ASTM F2077)
  • Static Compression Shear Bending (per ASTM F2077)
  • Dynamic Compression Shear Bending (per ASTM F2077)
  • Static Torsion (per ASTM F2077)
  • Subsidence (per ASTM F2267)
  • Expulsion
• Clinical Tests: "O N/A"

Therefore, I cannot provide the requested details because the document pertains to a physical medical device's engineering performance rather than a software device's analytical or clinical performance using AI.

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