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The Curiteva Thoracolumbar Plate System Two Hole and Four Hole Plates are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability, or via the anterior surgical approach below the bifurcation of the greatment of lumbar and lumbosacral (L1-S1) spine instability in skeletally mature patients as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation is achieved.

The Curiteva Thoracolumbar Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-SI ) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

The Curiteva Thoracolumbar Plate System is an internal fixation device for spinal surgery that consists of various configurations of spinal plates and bone screws. The implant configurations are available in different types and sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The plates come preformed with holes to receive bone screws. Screws are used to attach the plates to bone. All system implants are manufactured from Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

The provided text is a 510(k) premarket notification for the Curiteva Thoracolumbar Plate System. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices based on technological characteristics and non-clinical performance data.

However, the document does not contain information related to software, artificial intelligence (AI), diagnostic performance metrics, or clinical studies involving human readers or ground truth established by experts/pathology/outcomes data.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established, as this information is not present in the provided text.

The "Performance Data" section (F) explicitly states that "Non-clinical testing performed on the Curiteva Thoracolumbar Plate System supports substantial equivalence to predicate devices." It then lists biomechanical tests (static and dynamic compression bending, static torsion, static and dynamic cantilever bending) according to ASTM standards. These are engineering performance tests for a physical medical device, not diagnostic performance criteria for software or AI.

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The Cure™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The Cure™ Lumbar Plates (Cure™ - LP IView and Cure™ - QMax ) are available in a range of sizes to coincide with the surgical approach. The Cure™ - LP IView is identical to the Cure™ Anterior Lumbar plate with the exceptions of replacing the graft window with a through hole and the inclusion of a central rib at the through hole location. The Cure™ - LP QMax is identical to the Cure™ Lateral Lumbar plate with the exceptions of plate width and number of screw holes allocations. All Cure™ Lumbar Plates are manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The provided text describes a 510(k) premarket notification for the "Cure™ Lumbar Plate System." This document is a regulatory submission to the FDA, asserting substantial equivalence to an existing predicate device. It does not contain information about acceptance criteria or a study that rigorously proves the device meets specific acceptance criteria in the context of AI/ML performance.

Medical device approvals like this typically focus on demonstrating safety and effectiveness based on similarity to previously approved devices (predicates) and mechanical testing for physical properties. They do not involve the kind of performance studies with ground truth, expert readers, or AI/ML metrics that your questions refer to.

Therefore, I cannot answer most of your detailed questions about acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text.

Here's what I can extract based on the document's content:

• Device Name: Cure™ Lumbar Plate System
• Predicate Device: K171538 (Cure™ Lumbar Plate System)
• Purpose of the Submission: To demonstrate substantial equivalence of the Cure™ Lumbar Plate System (specifically the Cure™ - LP IView and Cure™ - LP QMax models) to the predicate device.
• Basis for Equivalence: Identical intended use and consistency in fundamental scientific technology.

Regarding "Non-clinical Testing" (Section G):
The document mentions "An engineering analysis was performed on the previously cleared Cure™ Lumbar Plate System" which "included static compression bending, static torsion, and dynamic compression bending." It concludes that the new plates are "superior in mechanical function and properties to the predicate device."

This section describes mechanical testing of the physical implant, not performance of an AI/ML algorithm. These tests are typically defined by ASTM standards and have their own internal acceptance criteria (e.g., minimum load-bearing capacity, fatigue life) but these are for the hardware and are not related to algorithm performance metrics like sensitivity, specificity, or reader improvement.

In summary, the provided document does not support answering the questions related to AI/ML device performance studies.

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