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The Spinal USA Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolater al surgicul approach above the bifurcation of the great vessel or via the exterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temperary fixation device until fusion is achieved. The Spinal USA Anterior Lumbar Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degreerative discase (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture and dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Spinal USA Anterior Lumbar Plate System consists of a range of plate and screw sizes. The plates come in sizes of: 21mm, 23mm, The screws come in 5.0mm and 5.5mm diameters and the screw lengths are 25mm, 30mm, 35mm. The plates locking mechanism is a preassembled rivet that is attached to every plate. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) and provide stabilization to permit the biological process of spinal fusion to occur. All components are made from medical grade titanium or titanium alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".

The provided text is a 510(k) summary for the Spinal USA Anterior Lumbar Plate System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

The information you are asking for (acceptance criteria table, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training set) is typically found in data describing the validation of AI/ML algorithms. The document provided outlines the regulatory submission for a physical medical device (an anterior lumbar plate system), for which "performance data" would refer to mechanical testing and biocompatibility rather than AI/ML algorithm performance.

Therefore, I cannot provide the requested information from the given text.

The provided text does not contain the necessary information to answer your questions regarding acceptance criteria and a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

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