Search Results

The SeaSpine Daytona Small System is intended for posterior, non-cervical 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. The indications for use are as follows: Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal stenosis; Deformities or curvatures (i.e., scoliosis, and/or lordosis); Spinal tumor; Pseudoarthrosis; and/or Failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the SeaSpine Daytona Small Stature Spinal System may be used for the above indications as an adjunct to fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Daytona Small Stature Spinal System is indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Additionally, the Daytona Small Stature Spinal System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Daytona Small Stature Spinal System can be attached to SeaSpine's Atoll OCT Spinal System, Sierra Spinal System, or Malibu Spinal System using the rod connectors. Refer to the Atoll, Sierra, or Malibu System's Package Insert for the indications for use for those systems.

The SeaSpine Daytona Small Stature Spinal System is a non-cervical spinal fixation device and instrumentation system intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle fixation system, or as an anterolateral fixation system. The system consists of single-use implants including polyaxial and monoaxial pedicle screws as well as connecting spinal rods and a separate locking element. All implants are manufactured from Titanium alloy (Ti-6Al-4V ELI per ASTM F136) and Cobalt Chrome alloy (Co-28Cr-6Mo per ASTM F1537).

The provided text is a 510(k) summary for the SeaSpine Daytona Small Stature Spinal System. This document focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than proving performance against specific acceptance criteria through a clinical study for a new or novel device, especially for an AI/ML-based medical device.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), as it is a submission for a spinal system, not an AI/ML device.

Specifically, the document states:

• Clinical Testing: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." (Page 5)

This explicitly means that clinical studies (which would involve the detailed information requested in the prompt) were not a part of this 510(k) submission for proving the device's performance. The review focused on mechanical testing and comparison to predicate devices' technological characteristics.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The device in question is a physical spinal implant system, not a software-based or AI/ML device that would typically undergo the kind of performance validation described in the prompt.

Ask a specific question about this device