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The aprevo® transforaminal lumbar interbody fusion device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® transforaminal lumbar interbody fusion device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® transforaminal lumbar interbody fusion device is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® transforaminal lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® transforaminal lumbar interbody fusion devices are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient and include an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient CT scans. The aprevo® devices are manufactured from titanium alloy (Ti-6A1-4V) per ASTM F3001 and are provided sterile.

The provided text is a 510(k) summary for a medical device (aprevo® transforaminal lumbar interbody fusion device). This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through a clinical or performance study with detailed metrics typically seen in AI/ML medical devices.

Therefore, the information required to answer your questions regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment (common for AI/ML device submissions) is not present in this 510(k) summary.

Here's why and what can be inferred:

• Acceptance Criteria & Device Performance: The document does not list specific numerical acceptance criteria for a device's "performance" in the way an AI/ML device would (e.g., sensitivity, specificity, AUC). Instead, it states that "Engineering analyses and confirmatory dynamic compression-shear testing per ASTM F2077 were conducted to support substantial equivalence to the predicate devices." This implies mechanical and material performance criteria, but the specific values or a direct comparison table are not provided.
• Sample Size (Test Set/Training Set) & Data Provenance: This 510(k) pertains to a physical implantable device. There are no "test sets" or "training sets" in the context of data for an AI/ML algorithm. The "testing" mentioned refers to biomechanical testing of the device itself (e.g., strength, durability), not the analysis of medical images or patient data by an algorithm to generate a diagnosis or prediction.
• Number of Experts, Ground Truth, Adjudication: These concepts are relevant for studies determining the accuracy of an AI/ML algorithm against human interpretation or confirmed diagnoses. They are not applicable to the clearance of a mechanical intervertebral fusion device. The "ground truth" for a device like this would be its physical properties meeting design specifications and regulatory standards.
• MRMC Study / Standalone Performance: These are specific to AI/ML device clinical evaluations. This document describes a physical medical device, not an AI algorithm.
• Ground Truth Type: Not applicable in the AI/ML sense. The "ground truth" for this device is its mechanical properties and biocompatibility.

In summary, based on the provided text, I cannot complete a table or answer the questions as they relate to the performance study of an AI/ML driven medical device.

The document details the device description, its indications for use, and states that "Engineering analyses and confirmatory dynamic compression-shear testing per ASTM F2077 were conducted to support substantial equivalence to the predicate devices." This means the device's mechanical properties were evaluated against an existing standard and shown to be comparable to another legally marketed device.

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