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When intended for pedicle screw fixation from T1 -S1, the Sequoia Thoracolumbar 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 the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor and failed previous fusion.

As pedicle screw system places between 1.3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.

When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity), degenerative dise disease (back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.

When intended for anterolateral screw, rod and/or cable fixation of the T6-L5 spine, the indications are degenerative disc disease (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, deformities or curvatures (i.e. scoliosis, and/or lordosis), turnor and failed previous fusion.

After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.

The use of posterior spinal instrumentation in children has been reported in the literature. The Sequoia Spinal System may be used for non-pedicle posterior use in this patient group.

The Sequoia Spinal System consists of various open style screws, rods and connectors and is intended to provide temporary stabilization following surgery to fuse the spine. This system includes titanium spinal pods in varying lengths. Additionally included are screws with a polyaxial design, allowing the surgeon to use a top loading technique for dropping the spinal rod down to the fixation components into a u-shaped opening.

The provided text describes the Abbott Spine Sequoia Spinal System, a spinal fixation device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through clinical or AI-based evaluations.

Instead, the document focuses on:

• Substantial Equivalence: The primary method of demonstrating safety and effectiveness for this device is through substantial equivalence to a predicate device (InCompass® Spinal Fixation System). This means the new device is compared to an already legally marketed device with similar indications and technological characteristics.
• Non-Clinical Performance Data: The submission states that "Laboratory and bench testing results demonstrate that the proposed device is substantially equivalent to the predicate device." This typically refers to mechanical and material testing to ensure the device meets engineering specifications and performs similarly to the predicate in a simulated environment.
• Absence of Clinical Performance Data: Crucially, the document explicitly states: "Clinical data and conclusions were not needed for this device." This confirms that no clinical study was conducted to demonstrate the device's performance in humans.
• Indications for Use: Detailed indications for when and how the device can be used in spinal fusion procedures are provided.

Therefore, since no clinical or AI performance study was conducted or reported in this document, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts for ground truth, adjudication methods, or MRMC/standalone studies for either a test set or training set.
• The type of ground truth used.

In summary, the provided document indicates that the Abbott Spine Sequoia Spinal System's acceptance was based on non-clinical (laboratory and bench) testing demonstrating substantial equivalence to a predicate device, and no clinical performance data was required or submitted.

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