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The Innovasis TxTi Transforaminal Lumbar IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via a transforaminal approach.

This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the implant is intended to be packed with autograft.

The Innovasis TxTi IBF System is an intervertebral body fusion device with associated instrumentation for use in Transforaminal Lumbar Interbody Fusion (TLIF) surgeries. The implants are 3D printed.

The single use implant devices feature a honeycomb structure with an open cavity in the interior geometry to accommodate bone graft and maximize bone through-growth, with anti-migration surface to engage the vertebral endplates and prevent expulsion. The implants have a slightly convex profile and are offered in a variety of different sizes to fit the anatomical needs of a wide variety of patients. The implant has a tapered leading edge which aids in implant insertion due to limited anatomical space. Reusable instruments to support TLIF surgeries are provided with the implants in custom sterilization trays.

The provided text does not contain information about the acceptance criteria and a study that proves a device meets specific acceptance criteria in the context of an AI/ML powered device.

The document is a 510(k) premarket notification for the TxTi™ IBF System, which is an intervertebral body fusion device. This is a physical medical implant, not an AI/ML software device.

The "Performance Data" section (Page 4) mentions "Performance testing per ASTM F2077-17 and F2267-04 for Static Axial Compression, Dynamic Axial Compression, Static Compression Shear, Dynamic Compression Shear, Subsidence and Expulsion testing indicates that the TxTi IBF is substantially equivalent to the predicates." This refers to non-clinical, mechanical testing of the physical implant, not a study evaluating AI/ML performance.

Therefore, I cannot extract the requested information, such as acceptance criteria for AI performance, sample sizes for test sets, expert adjudication methods, MRMC studies, standalone performance, or ground truth for training data, because the document describes a traditional physical medical device, not an AI/ML powered one.

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