Search Results

The Medyssey Co, Ltd. Zenius™ Spinal System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and /or allograft for the following indications: degenerative disc disease (DDD) (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; curvatures (i.e., scoliosis, kyphosis, and / or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Zenius™ System, Internal Fixation Device for Spinal Surgery is comprised of: rods, pedicle screw assemblies, compression retaining assemblies, set screws and transverse-link assemblies. Various forms and sizes of these implants are available so that adaptations can be utilized to account for the unique pathology of individual patients. Subject screws are manufactured from Ti6Al4V ELI per ASTM F136.

This document is a 510(k) premarket notification for a medical device called the "Zenius™ Spinal System." It is not a study of an AI/ML powered device. Instead, it details the substantial equivalence of an updated version of a pedicle screw system to existing predicate devices.

Therefore, the requested information about acceptance criteria, study design, expert involvement, ground truth, and AI/ML specific performance metrics cannot be extracted from this document. The document focuses on demonstrating that the modified hardware (the pedicle screw with fenestration) performs at least as well as its predicate devices through mechanical testing.

Here's why the specific questions can't be answered for this document:

• No AI/ML Component: The "Zenius™ Spinal System" is a physical implant (pedicle screws, rods). There is no mention or implication of any artificial intelligence or machine learning component in its design, function, or evaluation.
• Mechanical Testing, Not Clinical or Diagnostic Study: The "study" mentioned is "Mechanical Testing" (per ASTM F1717) to evaluate "static compression bending, static torsion, static tension, and dynamic compression bending." This is a laboratory test of the device's physical properties, not a clinical trial or a diagnostic performance study.
• Substantial Equivalence, Not Performance Acceptance Criteria for an AI: The FDA 510(k) process for this type of device focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This involves showing that the new device is as safe and effective as the predicate. It does not involve establishing clinical performance acceptance criteria for an AI algorithm.

In summary, this document is irrelevant to the prompt. The prompt asks for details about the acceptance criteria and the study proving an AI/ML device meets those criteria, which is not what this document describes.

Ask a specific question about this device