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The Spine Wave Gen II Expandable Interbody System is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1 when implanted using a posterior surgical approach and levels L2-L5 when implanted using a lateral surgical approach. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Gen II Expandable Interbody System is composed of wafers that are stacked into an expandable implant to adjust the height of the implants are manufactured of titanium alloy (Ti-6AI-4V, ASTM F136), PEEK-OPTIMA with 6% BaSO4, and commercially pure titanium (ASTM F1580). The Spine Wave Gen II Expandable Interbody System Implants are provided in various configurations to address the anatomical needs of a variety of patients and to accommodate various surgical approaches to the lumbar spine. The implants are to be used with autogenous bone graft material and supplemental fixation. The System also includes a delivery device that is used to both place and expand the implant. The implants are provided sterile.

The provided text does not contain information regarding software or AI device performance, acceptance criteria, or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification summary for a medical device called the "Spine Wave Gen II Expandable Interbody System," which is a physical implant for intervertebral body fusion procedures.

The information provided covers:

• Device Name: Spine Wave Gen II Expandable Interbody System
• Regulation Number: 21 CFR 888.3080
• Regulation Name: Intervertebral body fusion device
• Regulatory Class: Class II
• Product Code: MAX
• Indications for Use: Intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at specific levels (L2-S1 posterior surgical approach, L2-L5 lateral surgical approach), used with autogenous bone graft and supplemental fixation, after at least six months of non-operative treatment.
• Device Description: Composed of titanium alloy, PEEK-OPTIMA with BaSO4, and commercially pure titanium wafers stacked into an expandable implant. Includes a delivery device and is provided sterile.
• Predicate Devices: Multiple predicate devices from Spine Wave, Globus Medical Inc., LDR Spine USA, Ulrich GmbH & Co. KG, Biomet Spine, and Synthes Spine Co. LP.
• Non-Clinical Performance Data: Lists various ASTM standards for testing coating microstructure, shear testing, shear fatigue testing, tensile testing, abrasion testing, static and dynamic axial compression, static and dynamic compression shear, subsidence, and wear debris analysis. These are mechanical and material property tests for the physical implant, not software.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving a device meets acceptance criteria related to a software or AI device, as that information is not present in the provided document.

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