Search Results

The Syzygy Stabilization System is intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine, specifically as follows:

• When intended for pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients the Syzygy Stabilization System is indicated for one of the following: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); fracture; dislocation; scoliosis; kyphosis; spinal tumor; and/or failed previous fusion (pseudarthrosis).

· In addition, when used as a pedicle screw fixation system, the Syzygy Stabilization System is indicated for skeletally mature patients having degenerative spondylolisthesis with objective evidence of neurologic impairment and/or severe spondylolisthesis (grades 3 and 4) of the fifth lumbar-first sacral (L5-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 (L3 and below); and who are having the device removed after the development of a solid fusion mass.

The Syzygy Stabilization System consists of posted screws, couplers, and associated surgical instruments. The system is used in conjunction with the Amendia Savannah-T pedicle screw and rod system. The Syzygy posted screws are self-tapping with a cancellous thread design. They are available in cannulated and non-cannulated configurations, in a variety of diameters and lengths. The Syzygy posted screws are attached to the pedicles via couplers (medial and cranial) which accept and secure the longitudinal rods to build a rigid construct. The screws and couplers are manufactured from Ti-6AI-4V (ASTM F136) and are provided non-sterile for singleuse.

This document is a 510(k) premarket notification for the Syzygy Stabilization System, a medical device for spinal stabilization. The document does not describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based device performance evaluation, but rather for a traditional medical device (pedicle screw system).

Therefore, I cannot provide the requested information regarding AI device acceptance criteria and study details. The document focuses on mechanical testing of spinal implants and a cadaveric validation study to demonstrate substantial equivalence to predicate devices, which is typical for a 510(k) submission for this type of hardware.

Specifically, the document states:

• Acceptance Criteria & Device Performance: The document refers to "requirements as established by the test protocol and applicable ASTM standards" for mechanical tests, and "substantially equivalent to the Predicate" for the cadaveric validation study. However, it does not provide a table of numeric acceptance criteria or specific device performance metrics in a way that would be applicable to an AI device.
• Study Types: The studies performed were:
  • Static Axial Compression Bending (ASTM F1717-14)
  • Static Axial Tension Bending (ASTM F1717-14)
  • Static Torsion (ASTM F1717-14)
  • Dynamic Axial Compression Bending (ASTM F1717-14)
  • Dynamic Axial Tension Bending (ASTM F1717-14)
  • A Cadaveric validation study.
• The document does not include information on:
  • Sample size used for a test set (in the context of AI data splits)
  • Data provenance (country of origin, retrospective/prospective)
  • Number or qualifications of experts for ground truth
  • Adjudication method
  • Multi-reader multi-case (MRMC) comparative effectiveness study
  • Standalone algorithm performance
  • Type of ground truth (expert consensus, pathology, outcomes data, etc. in an AI context)
  • Sample size for a training set
  • How ground truth for a training set was established

The information provided pertains to the mechanical and general performance characteristics of a physical spinal implant system, not the performance of an AI or algorithmic medical device.

Ask a specific question about this device