Search Results

The Stryker Spine THOR™ Anterior Plating System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach below the bifurcation of the great vessels.

The Styker Spine THOR™ Anterior Plating System is intended for use in the lumbar and lumbosacral spine (L1-S1). THOR™ Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

• Degenerative disc disease (defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies);
• Pseudoarthrosis; .
• Spondylolysis; .
• Spondylolisthesis; .
• Trauma (i.e., fracture or dislocation); .
• Deformities (i.e., scoliosis or lordosis)
• Spinal Stenosis; and
• Failed Previous Fusion. ●

The Stryker Spine THORTM Anterior Plating System is designed for anterior and anterolateral stabilization of the lumbar and lumbosacral spine (L1-S1). The system consists of a variety of plates and bone screws manufactured from Titanium alloy. The plates have an anatomical shape design and are preassembled with rings to accommodate the insertion of bone screws.

The Stryker Spine THOR™ Anterior Plating System is a spinal fixation device, not an AI/ML powered device, therefore the information requested is not applicable in the context of AI/ML software. The provided text describes a 510(k) premarket notification for a medical device (spinal plating system), which is a physical implant, not a software algorithm. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to mechanical and biocompatibility testing against established standards and comparison to predicate devices, not performance metrics like accuracy, sensitivity, or specificity for an AI model.

Therefore, I cannot extract the requested AI/ML specific information from the provided document.

However, I can provide a summary of the provided information as it pertains to the device's regulatory review:

Summary of the Stryker Spine THOR™ Anterior Plating System 510(k) Submission:

The submission focuses on demonstrating substantial equivalence to predicate devices based on:

• Technological Characteristics: Mechanical performance (in compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004) and material biocompatibility.
• Intended Use: The device is designed for anterior and anterolateral stabilization of the lumbar and lumbosacral spine (L1-S1) in skeletally mature patients for various conditions (Degenerative disc disease, Pseudoarthrosis, Spondylolysis, Spondylolisthesis, Trauma, Deformities, Spinal Stenosis, and Failed Previous Fusion).

Key Information from the Document (non-AI/ML):

• Device Name: Stryker Spine THOR™ Anterior Plating System
• Classification Name and Number: Spinal Intervertebral Body Fixation Orthosis, 21 CFR 888.3060
• Product Code: KWQ
• Predicate Devices:
  • Synthes Anterior Tension Band System: 510(k) #K022791
  • Stryker Spine CENTAUR Spinal System: 510(k) #K994347, #K001844
  • Stryker Spine Xia Stainless Steel System: 510(k) #K012870
• Device Description: Consists of various plates and bone screws made from Titanium alloy, anatomically shaped, and preassembled with rings for screw insertion.
• Summary of Technological Characteristics (Study Information):
  • Testing was performed in compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004.
  • Demonstrated equivalent mechanical performance characteristics to Stryker Spine CENTAUR Spinal System and Stryker Spine Xia Stainless Steel System.
  • Demonstrated equivalent material biocompatibility to the Stryker Spine CENTAUR Spinal System.
  • Equivalent to the Synthes Anterior Tension Band System with respect to intended use.
• FDA Decision: Substantial Equivalence (K073437)

The document does not describe an AI/ML algorithm and therefore cannot provide data on sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, or standalone algorithm performance.

Ask a specific question about this device