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The EBI SpineLink™ System is a spinal fixation device for pedicle screw fixation and nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.

When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The screws of the system are limited to L3- S1 or iliac screw fixation with the fusion only at L5-S1.

When used as an anterior fixation system or a posterior hook and sacral/iliac screw fixation system, the system is indicated for nonpedicle spinal applications for the reduction, alignment or stabilization of the thoracic, lumbar and sacral segments of the spine, in cases of: Degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or revision of failed fusion attempts.

The EBI SpineLink™ System is a spinal fixation device that uses interconnecting links. This submission is for the addition of an 8.5 mm screw, 18 mm link (standard and reverse) and availability of screws in 25 and 30 mm lengths.

The provided text is a 510(k) summary and an FDA clearance letter for the EBI SpineLink™ System, a spinal fixation device. It describes the device's indications for use and states its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or specific studies proving the device meets those criteria in terms of performance metrics.

The document focuses on the regulatory clearance process rather than a detailed performance study report. It mentions "Engineering analysis comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements," but it does not provide details about this analysis, such as acceptance criteria, specific performance results, or study methodologies.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This information is not present.
• Sample size used for the test set and the data provenance: This information is not present.
• Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present.
• Adjudication method for the test set: This information is not present.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This type of study is not mentioned. Spinal fixation devices are typically evaluated through bench testing, mechanical testing, and clinical outcomes, not MRMC studies.
• If a standalone performance (algorithm only without human-in-the-loop performance) was done: This information is not present. This is not an AI device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not explicitly stated. The "engineering analysis" would likely rely on mechanical properties and design specifications.
• The sample size for the training set: This information is not present.
• How the ground truth for the training set was established: This information is not present.

The document is a regulatory submission for a medical device focusing on its design, materials, and intended use, and its substantial equivalence to already approved devices. It is not a clinical or performance study report in the way AI/software devices often require.

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