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The INNOVASIS 'Excella® Spinal System, when used for pedicle screw fixation is intended only for patients:
a) Having severe spondylolisthesis (Grade 3 & 4) at the L5-S1 joint;
b) Who are receiving fusion using autogenous bone graft only;
C) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below): and
d) Who are having the device removed after the development of a solid fusion mass.

The INNOVASIS 'Excella®' Spinal System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:
a) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
b) Fracture:
C) Dislocation:
d) Scoliosis:
e) Kyphosis:
f) Spinal tumor; and
g) Previous failed fusion (pseudoarthrosis).

The INNOVASIS 'Excella® Spinal System, when used for anterolateral nonpedicle fixation, is intended for the following indications:
a) Deqenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies):
b) Spinal stenosis;
C) Spondylolisthesis;
ರು) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
e) Pseudoarthrosis;
f) Tumor;
g) Trauma (i.e. fracture or dislocation); and
h) Previous failed fusion.

The INNOVASIS 'Excella® Spinal System, when used for posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
a) Degenerative disc disease (defined as back pain of disogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spinal stenosis;
c) Spondylolisthesis;
d) Spinal deformities (i.e. scoliosis, kyphosis and/or lordosis);
e) Pseudoarthrosis;
() Tumor:
g) Trauma (i.e. fracture or dislocation);
h) Previous failed fusion.

The Excella® Spinal System broadens to include the Excella® -P bone screws, which feature a multi-axial joint for free motion of the screw head to allow the physician greater flexibility when placing the screws, and a series of 4.5mm diameter polyaxial bone screws of 30mm, 35mm, 40mm and 45mm lengths. The locking caps for Excella®-P are a two piece design which includes a threaded locking screw attached to an alignment cap. The alignment cap is attached to the bottom of the locking screw and rotates about the radial axis. The modified cross connectors come in various pre-assembled, adjustable lengths and allow for variation in vertical placement on two rods.

This document is a 510(k) submission for a spinal system, not for an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics (sample sizes, ground truth establishment, expert involvement, MRMC studies, standalone performance) for an AI device is not available in the provided text.

The document discusses the mechanical performance testing for the Innovasis Excella® Spinal System to demonstrate substantial equivalence to predicate devices, but this is related to the physical properties of the spinal implants, not a software or AI/ML product.

Therefore, I cannot provide the requested table and study details for an AI/ML device based on the provided text, as the device described is a physical spinal implant system.

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