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The ENNOVATE® Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and nonpedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities:

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 ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. This system includes screws of varying types, diameters and lengths, hooks, rods, rod-to-rod connectors, lateral offset and cross connectors of various styles and lengths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 as well as CoCr alloy conforming to ISO 5832-12.
The ENNOVATE Spinal System is a spinal rod and screw system. This system's screws can be rigidly locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. All screws within this system are not intended for use with bone cement. Rods of this system may be shaped intraoperatively to correct or maintain proper spinal curvature. The hooks have curved blades underneath the head portion of the implant that wrap around posterior anatomy of the spine to provide an alternative method of anchoring the rod to the spine.

The provided text does not contain information about an AI/ML-powered medical device or its performance criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for the ENNOVATE® Spinal System, which is a physical medical device (a thoracolumbosacral pedicle screw system) used for spinal fusion.

Therefore, I cannot answer the questions related to acceptance criteria for an AI device, sample sizes for test sets, expert ground truth establishment, MRMC studies, or training set details, as this information is not present in the provided context for this specific device.

The "Performance Data" section in the document refers to biomechanical testing of the physical spinal implant system (e.g., dynamic/static compression, torsion tests per ASTM standards, endotoxin testing), not the performance of a software algorithm.

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