Search Results

The SeaSpine NewPort Spinal System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications:

• Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion,
• spondylolisthesis,
• trauma (i.e., fracture or dislocation),
• spinal stenosis,
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• spinal tumor.
• pseudoarthrosis, and/or
• failed previous fusion.

The SeaSpine NewPort Spinal System consists of pedicle screws, locking caps and rods, and is intended to act as a temporary or permanent posterior, non-cervical pedicle fixation implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

The NewPort implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) with a cobalt washer (Co-28Cr/6Mo per ASTM F1537). The NewPort screws are offered in a variety of lengths and diameters and NewPort rods are offered in a variety of lengths to accommodate patient anatomy. The instruments included in the NewPort System facilitate the placement, removal, adjustment, and final locking of the system implants. The instruments also include the trays and caddies for protection during storage and the steam sterilization process. The trays and caddies also provide a means for organization of the instruments during the surgical procedure.

The provided text is a 510(k) summary for the SeaSpine NewPort Spinal System. It details the device's characteristics, intended use, and a comparison to predicate devices for substantial equivalence. However, this document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/medical imaging device.

The SeaSpine NewPort Spinal System is a pedicle screw system, which is a medical implant used in spinal surgery. The FDA 510(k) process for such devices primarily relies on non-clinical mechanical testing to demonstrate substantial equivalence to existing predicate devices, rather than clinical efficacy studies or AI performance metrics.

The document explicitly states:
"Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, none of the specific criteria for AI/imaging device performance (acceptance criteria table, sample sizes, expert ground truth, MRMC study, standalone performance, training set details) can be extracted from this document, as they are not relevant to the approval pathway for this type of medical device.

In summary, based on the provided text, the device's acceptance was proven through non-clinical mechanical testing demonstrating substantial equivalence to predicate devices, not through a study involving AI performance or human reader improvements.

Ask a specific question about this device