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The TAMARACK™ Anterior Thoracolumbar Plating System is intended for fixation to the anterolateral vertebral bodies (T10 to L5). This system is intended for implantation on one side only for the treatment of thoracic and lumbar spine instability 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, kyphosis, lordosis, spinal stenosis, or failed previous fusion surgery.

The TAMARACK™ Anterior Thoracolumbar Plating System facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. Device implants include a range of sizes of plates, screws, bolts and a locking nut. All system components are made from titanium alloy (Ti 6Al-4V) meeting ASTM F-136.

The provided text describes a medical device, the TAMARACK™ Anterior Thoracolumbar Plating System, and its 510(k) summary for FDA clearance. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria in a clinical or AI context, or details about the development and validation of an AI algorithm.

The document focuses on:

• Device Description: What the device is, its components, and materials.
• Classification: Its regulatory classification.
• Indications for Use: The medical conditions and anatomical locations for which the device is intended.
• Substantial Equivalence: It claims substantial equivalence to a predicate device (Z-Plate by Medtronic Sofamor Danek, K991460). This is a common pathway for FDA clearance for Class II medical devices, where clinical trial data proving safety and effectiveness is not typically required if the device is sufficiently similar to an already cleared device.
• Performance Data: It briefly states that "Static and dynamic testing of the TAMARACK™ Anterior Thoracolumbar Plating System was performed and submitted in this application." This refers to mechanical testing of the physical hardware, not a clinical study involving human patients or an AI performance study.

Therefore, based on the provided text, I cannot complete the requested information, particularly regarding acceptance criteria, AI performance, sample sizes for training/test sets, ground truth establishment, or expert involvement. The device is a physical implant, not an AI/software device.

If you were expecting information about an AI-powered device, this document is not relevant to that type of inquiry.

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