(54 days)
The EXPEDIUM™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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 in skeletally mature patients.
The MOSS MIAMI™ Spine System is a pedicle screw system 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 the 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 MOSS MIAMI™ Spine Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The MOSS MIAMI™ Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). The EXPEDIUM™ Spine System 5.5mm Commercially Pure Titanium Rods may be used with mating titanium alloy components of the MOSS MIAMI™ Spine System which can accept a 5.5 mm diameter rod.
The MONARCH™ Spine System is a pedicle screw system 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neuroloqical impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The MONARCH™ Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autoqenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The MONARCH™ Spine System is also a hook and sacralliliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). The MONARCH™ Spine System when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine. The MONARCH™ Spine System Dual Rod Connectors can be used to connect MONARCH Spine System Rods to rods of other DePuy Spine 4.75mm, 5.5mm, and 6.35mm diameter rod systems. The EXPEDIUM™ Spine System 5.5mm Commercially Pure Titanium Rods may be used with mating titanium alloy components of the MONARCH™ Spine System which can accept a 5.5 mm diameter rod.
The EXPEDIUM™ Spine System Commercially Pure Titanium Spinal Rods are 5.5mm diameter rods available in various lengths. The rods are designed for use with previously cleared titanium alloy components of the EXPEDIUM™ Spine System, MOSS MIAMI™ Spinal System, and MONARCH™ Spine System which can accept a 5.5mm spinal rod, including monoaxial and polyaxial screws, hooks, and connectors. The rods will be labeled as components of the EXPEDIUM™ Spine System.
The Commercially Pure Titanium Rods are 5.5mm diameter spinal rods available in various lengths. The rods are designed for use with previously cleared titanium alloy components of the MOSS MIAMI™ Spinal System which can accept a 5.5mm spinal rod, including screws, hooks, and connectors.
The Commercially Pure Titanium Rods are 5.5mm diameter spinal rods available in various lengths. The rods are designed for use with previously cleared titanium alloy components of the MONARCH™ Spinal System which can accept a 5.5mm spinal rod, including screws, hooks, and connectors.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EXPEDIUM™ Spine System 5.5mm Commercially Pure Titanium Spinal Rods:
Based on the provided 510(k) summary, the device is a medical implant (spinal rods), and the "acceptance criteria" and "study" are related to biomechanical performance rather than diagnostic accuracy or AI performance. Therefore, many of the requested fields (like sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, and training set details) are not applicable in this context.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biomechanical characteristics (Implied) | Biomechanical test data were submitted to characterize the EXPEDIUM™ Spine System 5.5mm Commercially Pure Titanium Spinal Rods. (This implies that the device met pre-defined biomechanical standards or was demonstrated to be equivalent to predicate devices based on these tests, though the specific criteria and results are not detailed in the summary.) The materials used conform to ASTM F-67 (Grade 3 commercially pure titanium), which is a material standard. |
Study Details (Biomechanical Performance)
- Sample size used for the test set and the data provenance: Not explicitly stated. Biomechanical testing typically involves a set number of samples for various tests (e.g., fatigue, static bending), but the exact numbers are not detailed in this summary. The data provenance would be from laboratory testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For biomechanical testing of an implant, the "ground truth" is defined by standardized test methods (e.g., ASTM standards) and engineering principles, not expert medical consensus.
- Adjudication method for the test set: Not applicable. Biomechanical tests rely on objective measurement and predetermined pass/fail criteria based on engineering standards.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a biomechanical study, not a diagnostic imaging or AI-assisted clinical study.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a biomechanical study, not related to an algorithm's performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this type of device (spinal rods) is based on engineering standards and established biomechanical properties (e.g., strength, stiffness, fatigue resistance) as determined through laboratory testing against predicate devices and relevant ASTM standards.
- The sample size for the training set: Not applicable. This is not an AI/machine learning study, so there is no "training set."
- How the ground truth for the training set was established: Not applicable.
Summary of what the document indicates regarding the study:
The 510(k) summary states, "Biomechanical test data were submitted to characterize the EXPEDIUM™ Spine System 5.5mm Commercially Pure Titanium Spinal Rod." This indicates that laboratory tests were performed to evaluate the physical and mechanical properties of the spinal rods. These tests would have been designed to ensure the rods meet the necessary performance requirements for their intended use and demonstrate substantial equivalence to the predicate devices (EXPEDIUM™ Spine System, MOSS MIAMI™ Spinal System, MONARCH™ Spine System). The material conformance to ASTM F-67 is also a key part of the characterization. The acceptance criteria would likely be implicit in demonstrating equivalent biomechanical performance to the predicate devices as per FDA guidance for spinal systems.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.