(164 days)
The SYNTHES (USA) Universal Spinal Parallel Connector is part of the Universal Rod and Screw Fixation System and is intended for anterolateral screw/staple fixation for the correction of anterolateral lordotic deformities of the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine, (levels T8-L5).
The Synthes Universal Spinal Rod and Screw Fixation System consists of rods, and 6, 7, and 8 mm diameter side-opening screws with a collar and nut. The system also includes a staple, a washer and a parallel connector. The Universal Spinal side-opening screws attach to the anterolateral portion of the vertebral body of the thoracolumbar spine (levels T8-L5) and are connected via a rod. The Synthes Universal Spinal Rod and Screw Fixation System Parallel Connector is provided non-sterile: moist heat sterilization is recommended.
This document is a 510(k) summary for a medical device (SYNTHES (U.S.A.) Universal Spinal Rod, and Screw Fixation System Parallel Connector) seeking clearance from the FDA. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a diagnostic AI study would.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device (Acromed Kaneda SR (Smooth Rod) Anterior Spinal System). Substantial equivalence means the new device is as safe and effective as a legally marketed predicate device. This is a regulatory pathway, not a performance study as typically understood in the context of AI or advanced diagnostic devices.
Therefore, I cannot provide the requested information in the format given, as the document does not contain:
- A table of acceptance criteria and reported device performance: This document does not describe performance metrics or acceptance criteria for a diagnostic or AI-driven outcome. It compares the intended use, materials, and dimensions of a physical implantable device.
- Sample size used for the test set and the data provenance: No "test set" in the context of data analysis is mentioned.
- Number of experts used to establish the ground truth: No ground truth is established through expert review in this context.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a physical medical device, not a diagnostic or AI system.
- Standalone performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
This 510(k) summary indicates that the SYNTHES (U.S.A.) Universal Spinal Parallel Connector is deemed substantially equivalent to the Acromed Kaneda SR (Smooth Rod) Anterior Spinal System based on:
- Same intended use: Both are for anterolateral screw/staple fixation for specific spinal conditions (e.g., anterolateral lordotic deformities, lumbar scoliosis, pseudoarthrosis, fracture/dislocation of thoracolumbar spine, levels T8-L5).
- Similar component dimensions and sizes: The new device is similar in physical characteristics to the predicate.
- Material comparison: The predicate is made from certified Implant Grade stainless steel and a titanium alloy. The summary implies the new device uses comparable materials, though it doesn't explicitly state the materials of the Synthes device in this excerpt.
In summary, this document is for a physical implantable device and uses the regulatory concept of "substantial equivalence" rather than performance metrics from a clinical or diagnostic study.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.