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The Deploy™ Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of carcellous bone graft when used as an adjunct to fusion in patients with degenerative disease (DDD) at one level or two contiguous levels of the lumbar spine (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 I spondylolisthesis at the involved levels. These patients should be skeletally mature and have at least six months of non-operative treatment prior to being treated with this system. Additionally, the Deploy™ implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. Deploy™ implants are intended to be used with supplemental spinal fixation systems that are cleared for use in the lumbosacral spine.

The Deploy™ Expandable Interbody System is comprised of the interbody implant cages, surgical instruments which include trial instruments to aid in the selection of the appropriate implant size for the patient's anatomy, and sterilization trays. The implants are manufactured from titanium alloy Ti-6AI-4V (ASTM F136, ASTM F3001) and are offered with various heights and shapes for different patient anatomy. Each implant is designed to be inserted and then rotate in-situ, providing immediate fixation and the arm deployed for the graft containment area. Ridges on the superior and inferior surfaces of the titanium implants contact the endplates to resist expulsion forces. The implants are designed to be used in conjunction with supplemental spinal fixation instrumentation. The surgical instruments are manufactured from stainless steel (ASTM F899. ISO 7153-1). The implants and surgical instruments are provided non-sterile and require sterilization prior to use within sterilization trays following validated sterilization parameters as provided within the Instructions for Use.

The provided text is a 510(k) summary for the Deploy™ Expandable Interbody System, which is a medical device. This document focuses on the regulatory clearance for the device and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of AI/software performance.

Therefore, the requested information regarding acceptance criteria, reported device performance in a clinical study, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document as it is not a clinical study report for an AI/Software as a Medical Device (SaMD).

The document discusses:

• Device Description: The Deploy™ Expandable Interbody System is comprised of interbody implant cages and surgical instruments, manufactured from titanium alloy.
• Indications for Use: Intervertebral body fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1), and for patients diagnosed with degenerative scoliosis, used with autograft and/or allogenic bone graft and supplemental spinal fixation systems.
• Technological Characteristics: Similar to predicate devices in principle of operation, design, intended use, material composition, and function.
• Summary of Testing: Biocompatibility risk assessment (ISO 10993-1, Part 5) and mechanical testing including static axial compression (ASTM F2077), static compressive shear (ASTM F2077), dynamic axial compression (ASTM F2077), dynamic compressive shear (ASTM F2077), static subsidence (ASTM F2267), and wear debris testing (ASTM F1877). These are engineering performance tests, not clinical performance for diagnostic accuracy.
• Substantial Equivalence Conclusions: The device was shown to be substantially equivalent to predicate systems based on indications for use, design, function, material composition, sizes, and mechanical performance.

This document is a regulatory submission demonstrating the safety and effectiveness of a physical medical implant, not an AI/software product, and thus does not contain the information requested about acceptance criteria and studies for AI/software performance.

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