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The Whistler Modular Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Whistler Modular Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, and locking cap set screws. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All implant components are made from titanium alloy (ASTM F136). The Whistler Modular Pedicle Screw System is provided in both non-sterile and sterile forms. All implants are intended for single use only.

The provided document is a 510(k) Premarket Notification from the FDA for the Whistler Modular Pedicle Screw System. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information regarding an AI/ML-driven device or studies proving its performance against acceptance criteria in the context of diagnostic accuracy, image analysis, or similar AI-related applications.

Instead, this document focuses on a physical medical device (pedicle screw system) and its mechanical performance testing to demonstrate substantial equivalence to existing devices. The performance data listed (Static Axial Compression Bending, Static Torsion, Dynamic Axial Compression Bending, Static A-P load) are standard mechanical tests for spinal implants, not AI performance metrics.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves a device meets acceptance criteria in an AI/ML context using the provided text. The document is entirely about a hardware implant.

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