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When used as an interbody fusion device, the TRULIFT® Expandable Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The TRULIFT® Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the TRULIFT® Expandable Spacer System components with components from any other system or manufacturer. The TRULIFT® Expandable Spacer System components should never be reused under any circumstances.

I apologize, but the provided text from the FDA 510(k) clearance letter for the "TruLift Expandable Spacer System" deals with a spinal implant (intervertebral body fusion device), not an AI/ML-enabled medical device for which the requested information regarding acceptance criteria, study findings, sample sizes, expert ground truth, and human-in-the-loop performance would be relevant.

The document discusses the mechanical and material equivalence of the TruLift system to predicate spinal implants, based on ASTM performance standards for devices of its type (e.g., static axial compression, dynamic compressive shear). It does not involve any form of AI, image analysis, or diagnostic/prognostic capabilities that would require the kind of clinical validation study you've described.

Therefore, I cannot extract the information you've requested about acceptance criteria and a study proving an AI device meets them, because this document pertains to a traditional, mechanical Class II medical device.

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