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BluEX Lumbar Expandable Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion.

BluEX Lumbar Expandable Cage System is intended for use at either one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Patients should have at least six months of non-operative treatment with a lumbar intervertebral fusion device. The BluEX Lumbar Expandable Cage System must be used with supplementary internal spinal fixation system that are cleared by the FDA for use in the lumbar spine. Hyperlordotic interbody devices (≥20 lordosis) must be used with at least anterior supplemental fixation.

The BluEX Lumbar Expandable Cage System is an interbody fusion device. This cage system is made of Titanium 6AL-4V Alloy (ASTM F136). And the cages are offered in a variety of widths, lengts and lordotic angles designed to adapt to a variety of patient anatomies.

This product consists of BluEX-T, BluEX-ATP, BluEX-LT and BluEX-A which are classified by surgical approach (refer to below table 1. BluEX Lumbar Expandable Cage System)

The cage can be expanded in height using the system inserted in the unexpanded state. The cages have serrations on the superior and inferior surfaces designed for fixation.

The BluEX Lumbar Expandable Cage System allows packing autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstance.

Surgical approach

• · BluEX-T is to be implanted via transforaminal and posterior approach.
• · BluEX-TC is to be implanted via transforaminal and posterior approach.
• · BluEX-ATP is to be implanted via anterior to psoas approach and lateral approach.
• BluEX-L is to be implanted via direct lateral approach.
• · BluEX-LT is to be implanted via direct lateral approach.
  · BluEX-A is to be implanted via anterior approach.

The provided text describes a medical device, the "BluEX Lumbar Expandable Cage System," and establishes its substantial equivalence to predicate devices. However, the document does NOT contain information about acceptance criteria, device performance, sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI/software-driven medical devices.

The context of the document is a 510(k) premarket notification for an intervertebral body fusion device, which is a physical implant. The provided text explicitly mentions "non-clinical testing, including chemical, physical. Testing has provided reasonable assurance of safety and effectiveness for its intended use and supports a determination of substantial equivalence." This indicates that the primary focus of the testing outlined in the document is on the mechanical and material properties of the physical implant, not on the performance of a software algorithm.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, etc.) related to an AI/software-driven device or study from the given text.

The relevant section for performance data states:

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Recognition No. 11-347 ASTM F2077-18 Test Methods for Intervertebral Body Fusion Devices Recognition No. 11-185 ASTM F2267-04 (Reapproved 2018) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
N/A
Mechanical test (performance test)
The results of these mechanical tests were found to be equivalent to or higher than the acceptable criteria compared to the predicate devices PathLoc Lumbar Interbody Fusion (K213441) for Static and Dynamic Compression and shear test and ANYPLUS ALIF PEEK CAGES, PLF PEEK CAGES, T-PLF PEEK CAGES (K131612) for subsidence value as stated in the Acceptable criteria. In addition, the dynamic tests were conducted and height changes observed at regular intervals were confirmed to be unchanged. Therefore, this test report concludes that the BluEX Lumbar Expandable Cage system has mechanical safety.

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