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JULIET® OL Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. JULIET® Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

JULIET® range of products consists of lumbar Interbody cages available in various models to adapt to anatomical variations and surgical techniques. JULIET® OL cages are dedicated to transforaminal approach and are manufactured as single solid-machined piece made of PEEK conforming ASTM F2026. Markers made of tantalum conforming to ASTM F0560 are used to visualize the position of the implant in the disc space. JULIET® OL Lumbar Interbody Devices are supplied either sterile or non sterile with a complete set of surgical instruments.

The provided document is a 510(k) summary for the JULIET® OL Lumbar Interbody Device. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

The "Performance data" section refers to mechanical testing of the intervertebral body fusion device, not an AI algorithm. It states:

• "Mechanical testing includes static axial compression performed according to ASTM F2077-03 and subsidence testing performed according to ASTM F2267-04."
• "Results demonstrate that additional components perform as safely and effectively as their predicate devices."

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets those criteria, as the document does not relate to an AI/ML medical device and thus does not include the type of performance study details requested (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details).

This document is for a traditional medical device (an intervertebral body fusion device) and focuses on mechanical performance and substantial equivalence to a predicate device, rather than the performance of an AI/ML algorithm.

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