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The ELITE™ L Expandable Lumbar Fusion System is indicated for use as intervertebral body fusion devices in sketetally mature patients with Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine from L2-L5. Patients should have received a minimum of six months of non-operative treatment prior to surgery. These patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). These implants are intended for use with autogenous bone graft and supplemental internal fixation systems such as a pedicle screw or anterior plating system.

The Elite™ L is a titanium alloy (Ti6Al4V-ELI) implant that is designed to provide mechanical support of the intradiscal space while biologic fusion occurs. The device is available in a variety of footprints, all of which are inserted in the unexpanded state and are expanded in situ. There are various heights to accommodate varied patients' anatomy. The implants are available in parallel and lordotic angles, with the implant end plates being bi-convex to optimize contact with the vertebral body end plates. All implants are made from medical grade titanium alloy. Implants have a locking mechanism to hold the implant in the expanded position once deployed.

This document is a 510(k) summary for the ELITE™ L Expandable Lumbar Fusion System, which is an intervertebral body fusion device. The purpose of this submission is to add devices to be implanted from the lateral surgical approach.

Unfortunately, the provided text does not contain explicit acceptance criteria or details of a study that proves the device meets specific performance criteria in the way you've outlined for statistical performance of an AI/ML device.

This document describes a medical device and its substantial equivalence to a predicate device, which is a common pathway for FDA clearance for certain medical devices. The "performance testing" mentioned refers to mechanical and functional testing of the physical implant, not performance in terms of diagnostic accuracy or clinical outcomes of an AI/ML system.

Therefore, I cannot populate your requested table and study details. The information provided is for a physical medical implant and focuses on:

• Mechanical Testing: According to ASTM F2077 (Static and dynamic axial compression, subsidence resistance, and expulsion resistance of an intervertebral body fusion device) and ASTM F2267 (Standard Test Method for Measuring Load-Displacement Properties of Spine Implants Under Compression or Shear).
• Finite Element Analysis (FEA): Used to compare the new device (Elite™ L) to the primary predicate device (Elite Expandable Interbody Fusion Device) and demonstrated "greater strength and durability to static and dynamic forces."

The criteria for this type of device are primarily related to its mechanical properties and biocompatibility, ensuring it can perform its intended function of supporting the intradiscal space and facilitating fusion without failure. The "acceptance criteria" here would implicitly be that the device performs at least as well as, or better than, the predicate device in these mechanical tests and that its materials, dimensions, and function are substantially equivalent to legally marketed predicate devices.

To directly answer your numbered points based on the provided text, I must state that most of the requested information regarding AI/ML device performance is not available.

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and the data provenance: Not applicable. This refers to mechanical testing of physical implants, not data analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Gor mechanical testing, ground truth is established by engineering standards and measurements.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used: For mechanical testing, the "ground truth" would be the direct measurements obtained from standardized physical tests and the results of Finite Element Analysis.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

In summary, the provided document describes the mechanical and functional characteristics of a physical medical device and asserts its substantial equivalence to a predicate device based on standardized mechanical testing and FEA. It does not involve any AI/ML components or studies of diagnostic accuracy in the way your questions are framed.

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