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TREND II Spinal Fixation System - STEP Series is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1-Sacrum/Ilium) 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)
• Degenerative Spondylolisthesis with objective evidence of neurologic impairment
• Fractures
• Dislocation
• Scoliosis
• Kyphosis
• Spinal tumor
• Failed previous fusion (pseudarthrosis)

TREND II Spinal Fixation System- STEP Series includes cannulated screw, non-cannulated screw, rod, set screw, hook, and transverse link. Different types or sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The system components are manufactured from Ti6Al4V based which complies with ASTM F136 /ISO 5832-3.

This document is a 510(k) premarket notification from the FDA, focusing on the substantial equivalence of "TREND II Spinal Fixation System- STEP Series" to predicate devices. It does not describe an AI medical device or a study involving human-in-the-loop or standalone AI performance. Therefore, I cannot extract the information required to answer your prompt regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI device.

The document primarily discusses:

• Device Type: Thoracolumbosacral pedicle screw system (a traditional medical implant, not AI)
• Regulatory Class: Class II
• Product Code: NKB
• Indications for Use: Spinal immobilization and stabilization for various conditions (e.g., degenerative disc disease, fractures, scoliosis)
• Predicate Devices: Comparison to "Paonan" Armstrong Posterior Spinal Fixation System (K161225) and MYKRES Spinal System (K051704).
• Performance Data: Mechanical testing (static/dynamic axial compression bending, static torsion, pullout test) to demonstrate substantial equivalence, referring to ASTM F1717 and ASTM F543. These are engineering performance tests for physical implants, not AI algorithm performance.

Therefore, it is impossible to provide the requested information about acceptance criteria and an AI study from this document.

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The MYKRES Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis, with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis),

The MYKRES Spinal System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients undergoing fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.

When used as an anterior, noncervical screw fixation system, the MYKRES Spinal System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, or failed fusion (pseudarthrosis).

The subject of this submission is the addition of new system components to facilitate use of the MYKRES Spinal System for anterior noncervical spinal fixation and the addition of such an indication to the statement of intended use. The MYKRES Spinal System, consisting of rods, screws, hooks, connectors and washers, was cleared under K051704 for posterior noncervical spinal fixation. Three new components are available for use in various combinations with certain components previously cleared for posterior spinal fixation

This 510(k) submission (K071074) for the MYKRES Spinal System is a medical device submission, not an AI/ML device submission. Therefore, the provided content is focused on demonstrating substantial equivalence to predicate devices based on design principles and indications for use, rather than presenting acceptance criteria and study results for device performance in the context of AI/ML.

The provided document does not contain information about:

• Acceptance criteria in terms of performance metrics (like sensitivity, specificity, AUC)
• A specific study proving the device meets performance criteria, as would be expected for an AI/ML device (e.g., a clinical trial comparing AI vs. human readers)
• Sample sizes for test sets or training sets
• Data provenance
• Number/qualifications of experts
• Adjudication methods
• MRMC comparative effectiveness studies
• Standalone performance studies
• Type of ground truth used

Instead, the submission focuses on:

• Intended Use: Expanding the indications for use to include anterior noncervical spinal fixation.
• Device Description: Adding new system components to facilitate anterior noncervical spinal fixation.
• Equivalence to Marketed Product: Demonstrating substantial equivalence to:
  • The previously cleared MYKRES Spinal System (K051704) for posterior noncervical spinal fixation.
  • Other predicate devices like the CD Horizon® Spinal System (K032265), Kaneda SR Anterior Spinal System (K971248, K974757), and Xia Spine System (K984251) in terms of indications and design principles.

In summary, this document is a regulatory submission for a traditional medical device, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML-specific performance metrics is not available in the provided text.

Ask a specific question about this device