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The NOVA Minimally Invasive 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 the thoracic, lumbar, and sacral spine:

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
2. Spondylolisthesis,
3. Trauma (i.e., fracture or dislocation),
4. Spinal stenosis.
5. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. Tumor,
7. Pseudoarthrosis, and
8. Failed previous fusion

The NOVA Minimally Invasive System consists of cannulated polyaxial screw, straight and pre-bent rods and set screws. The components are manufactured from titanium alloy per ASTM F136. The screws range in diameter from 5.5 mm to 7.0 mm and in length from 20 mm to 70 mm. The implants are not compatible with components or metal from any other manufacturer's system. The NOVA Minimally Invasive System can be used for both percutaneous and mini-open surgery

The provided text is a 510(k) summary for the NOVA Minimally Invasive System. It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device (K182416).

This document does not contain any information about acceptance criteria or a study proving the device meets those criteria for algorithmic performance. The device described is a medical implant (thoracolumbosacral pedicle screw system), not a software or AI-based diagnostic device. The "Performance Characteristics" section explicitly states: "The mechanical testing performed for the subject NOVA Minimally Invasive System with its components and the predicate devices is in accordance with ASTM F1717. There are no design change are involved for the design verification tests. The performance data for design control activities are unnecessary this time."

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, or MRMC studies, as the document does not pertain to the validation of an algorithmic or AI-based device. The 510(k) submission primarily focuses on mechanical performance and substantial equivalence to an existing physical device.

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