Search Results

The LDR Easyspine System is a posterior, noncervical pedicle and non-pedicle system 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 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, kyphosis, and/or lordosis)
• Tumor
• Pseudoarthrosis
• Failed previous fusion

Easyspine® implants are single use devices for mono-and multi-segmental stabilization of the lumbar and thoracic vertebrae to promote fusion. Easyspine® consists of sacral and pedicle screws, transverse connectors, hooks, and rods of different rigidities. Specialized associated instrumentation is designed for implantation of these devices and for the distraction, compression or reduction of the lumbar and thoracic spine.

The provided text describes a 510(k) summary for the LDR Spine USA Easyspine System. However, it does not contain any information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document primarily focuses on:

• Identification of the device: Trade Name, Common Name, Classification, Owner, Contact Person.
• Date of submission.
• Description of the device: Components and purpose.
• Intended Use: Specific spinal conditions it's designed to treat.
• Legally Marketed Equivalent Predicate Device: LDR Spine Easyspine System (K043094).
• Non-Clinical Performance Data: A statement that mechanical test results demonstrated substantial equivalence of a modified transverse connector design to the predicate device, and that the fundamental scientific technology remains unchanged.
• FDA's clearance letter: Confirming substantial equivalence.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

Ask a specific question about this device