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The 5.5 Helical Flange Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use; degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

The 5.5 Helical Flange Spinal System Percutaneous Instruments, when used with the 5.5 Helical Flange Spinal System cannulated screws and percutaneous rods, are indicated to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications, regardless of intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., kyphosis, and lordosis), stenosis, pseudoarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients.

The 5.5 Helical Flange Spinal System Mini-Open Instruments, when used with the 5.5 Helical Flange Spinal System implants are indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery for the following indications, regardless of intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., kyphosis, and lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients.

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The provided text describes a 510(k) premarket notification for the EBI® 5.5 Helical Flange Spinal System. This document focuses on the substantial equivalence of a medical device to legally marketed predicate devices, rather than on the performance of an AI/ML powered device. As such, the information typically required for acceptance criteria and studies proving the device meets these criteria for AI/ML devices (e.g., accuracy metrics, sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies) is not applicable or present in this document.

The document primarily discusses:

1. Technological Characteristics: States that mechanical testing was conducted and demonstrates conformity to design specifications, which were based on predicate devices. It confirms the system "adequately meets the requirements established in design specifications for its mechanical performance."
2. Substantial Equivalence: Asserts that the device is substantially equivalent to other legally marketed spinal fixation devices regarding intended use, indications, technological characteristics, and basic principles of operation.

Since this document pertains to a traditional spinal fixation system and not an AI/ML powered device, the requested information (performance metrics, study design, expert involvement, etc. for AI/ML) cannot be extracted from the provided text.

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