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When used as a pedicle screw system, the Synthes Universal Spinal Parallel Connector is intended for patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lunbar-first sacral (LS-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of a solid fusion.

When used as a nonpedicle screw system, it is also intended for scoliotic, or kyphotic deformities (such as scoliosis, Schueremann's disease); degenerative disk disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; and fractures of the posterior thoracolumbar spine (levels T8-S2)

The overall levels of fixation are T8-S2.

The Synthes (USA) Universal Hook, Rod, and Pedicle/Sacral Screw Fixation System consists of rods, various hooks and screws, a trans-connector system, transverse bars and a parallel connector. The hooks and screws attach to the rod via a collar and a nut. The trans-connector system consists of a trans-connector bar and two trans-connector clamps. The trans-connector clamps attach to each rod; the trans-connector bar attaches to the transconnector clamps, and the clamps attach to the rod via a collar and a nut. There are additional components to the Synthes (USA) Universal Spinal System: transverse bars. It is manufactured from Ti-6Al-7Nb and 316L stainless steel.

The Synthes Universal Spinal Parallel Connector is provided non-sterile; moist heat sterilization is recommended

The provided text is a 510(k) summary for a medical device (Synthes (USA) Universal Spinal Parallel Connector) and focuses on describing the device, its intended use, and substantial equivalence to existing devices. It does not contain information about acceptance criteria, device performance metrics, study details, or ground truth establishment typically found in a clinical study report or a more detailed regulatory submission.

Therefore, I cannot provide the requested information in a table or answer the specific questions about sample size, expert involvement, adjudication, MRMC studies, standalone performance, or training set details.

The document only states that:

• The Synthes (USA) Universal Spinal Parallel Connector is substantially equivalent to the Texas Scottish Rite Hospital (TSRH) Crosslink Axial Plate, and the Cotrel Dubosset (CD) System Domino.

Substantial equivalence is a regulatory concept meaning that the new device is as safe and effective as a legally marketed predicate device. This determination is usually based on comparison of intended use, technological characteristics, and performance data (often non-clinical, such as mechanical testing, for devices like spinal connectors). The document mentions that the predicate system (TSRH Crosslink Axial Plate) is "similar in component dimensions and sizes" to the Synthes device, which is a key part of demonstrating substantial equivalence for this type of device.

To answer your questions, I would need a different type of document, such as:

• A clinical study report
• A pre-market approval (PMA) application summary
• A more detailed scientific publication about the device's performance

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