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The Medyssey Co, Ltd. Iliad Pedicle Screw System and Zenius Pedicle Screw System are intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Iliad TM Spinal Fixation and Adjustable Bridge System, Internal Fixation Device for Spinal Surgery is comprised of: Rods, Pedicle Screw Assemblies, Compression Retaining Assemblies, and Transverse-Link Assemblies. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients.

Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136. The Cobalt-Chrome rods are made from wrought Co-Cr-Mo alloy, which complies with ASTM F1537.

The Zenius™ Spinal System, Internal Fixation Device for Spinal Surgery is comprised of: Rods, Pedicle Screw Assemblies, Compression Retaining Assemblies, and Transverse-Link Assemblies. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136. The Cobalt-Chrome rods are made from wrought Co-Cr-Mo alloy, which complies with ASTM F1537.

The provided text is a 510(k) Summary for the Iliad Pedicle Screw System and Zenius Pedicle Screw System. It describes the device, its indications for use, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain the specific information required to answer your questions about acceptance criteria and a study proving device performance in the context of an AI/ML device.

This document describes a traditional medical device (spinal fixation system), not an AI/ML device. Therefore, the concepts of acceptance criteria for an algorithm, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable and are not present in this regulatory submission.

Here's a breakdown of why this document doesn't fit your request and what information it does provide:

• Device Type: Traditional medical device (spinal implant).
• Purpose of 510(k) Summary: To demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. This is different from proving that an AI algorithm meets specific performance metrics.
• Performance Standards: Refers to pre-clinical testing for mechanical properties (Flexural Grip, Torsional Grip, Static Compression Bending, Dynamic Compression Bending) conducted according to ASTM F1717-13 and ASTM F1798-13. This is about the physical integrity and strength of the implant components, not the diagnostic or predictive performance of an algorithm.

In summary, none of the specific questions about acceptance criteria, study design for AI/ML performance, ground truth, or sample sizes can be answered from this document because it pertains to a different type of medical device.

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