Search Results

The Ti Fenestrated Plate is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The Ti Fenestrated Plate is intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion.

The Ti Fenestrated Plate is attached to the spine posteriorly by means of Songer Cables. The levels of attachment are T1 to L5.

The Ti Fenestrated Plate is indicated for the following:

1. Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
2. Idiopathic scoliosis.
3. Kyphotic deformities of the spine.
4. Lordotic deformities of the spine.
5. Vertebral fracture or dislocation.
6. Tumors.
7. Spondylolisthesis.
8. Stenosis.
9. Pseudarthrosis.
10. Unsuccessful previous attempts at spinal fusion.

The Interpore Cross International Ti Fenestrated Plate is a titanium plate containing multiple holes along the length of the plate. The Ti Fenestrated Plate is intended for use in the thoracolumbar spine from T1-L5. The plate is secured to the posterior spine via Songer Cables. The Songer Cables are placed through the holes in the Ti Fenestrated Plate and passed under and around the lamina. The plate and cable(s) are then secured to the spine using a tensioner/crimper instrument to obtain the appropriate tension level and to secure the cable crimp.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. This document is a 510(k) summary for a medical device called the "Ti Fenestrated Plate". It primarily focuses on the device's classification, name, predicate device, indications for use, and a comparison to the predicate device to establish substantial equivalence.

Here's a breakdown of why the requested information is not present:

• Acceptance Criteria and Reported Device Performance: This section is completely absent. The document states that the new device has "equivalent biomechanical performance" to the predicate, but it doesn't provide specific quantitative acceptance criteria or detailed performance data for either device.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set): None of these details are mentioned. The comparison to the predicate device is a regulatory argument for substantial equivalence, not a clinical or performance study report with the requested metrics.

The 510(k) summary format often focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive de novo clinical trials or detailed performance studies like those seen for novel high-risk devices. Substantial equivalence is often argued based on similar materials, design, intended use, and indications for use, sometimes supplemented with non-clinical (e.g., bench) testing, but not necessarily a full-fledged clinical study with the rigor implied by your questions.

Ask a specific question about this device