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The Innovasis® LxHA™ PEEK Lateral IBF 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 using a lateral approach.

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

The LxHA PEEK Lateral IBF System is Innovasis' next generation intervertebral body fusion device with associated instrumentation for use in Lateral Lumbar Interbody Fusion (LLIF) surgeries. The L-Box IBF was initially submitted to FDA under K121581 in September 2012 and was cleared for sale in the USA on October 17, 2012.

The LxHA implants will be manufactured using Invibio PEEK-Optima HA Enhanced. In this material, hydroxyapatite (HA) is integrated with Invibio's PEEK-OPTIMA Natural. The LxHA implants will be manufactured using HA PEEK and are to be sold sterile.

The single use implant devices feature an open cavity in the interior geometry to accommodate bone graft and maximize bone through-growth, with anti-migration teeth to engage the vertebral endplates and prevent expulsion. The implants are offered in a variety of different sizes to fit the anatomical needs of a wide variety of patients, including 0°, 8°, 12°, and 16° of lordosis. The implant has a tapered leading edge which aids in implant insertion due to limited anatomical space. Reusable instruments to support LLIF surgeries are provided with the implants in sterilization trays.

The provided text is a 510(k) summary for a medical device (LxHA™ PEEK Lateral IBF System) seeking FDA clearance. It describes the device, its intended use, and indicates its substantial equivalence to predicate devices based on non-clinical performance data.

However, the document does not contain any information regarding a study involving AI or human readers, acceptance criteria related to AI performance, or the methodologies for establishing ground truth for AI training/testing. The "Performance Data" section solely refers to non-clinical mechanical testing of the implant itself, not a diagnostic or AI-driven system.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of AI, human readers, or ground truth establishment, as this information is not present in the provided text.

The document discusses the physical device (an intervertebral body fusion device) and its mechanical performance, not a software or AI-driven diagnostic tool.

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