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The Alpha Mirage® Top Tightening Spinal System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Alpha Mirage® Top Tightening Spinal System are dependent in part on the configuration of the assembled device and the method of attachment to the spine and are listed in Indications for Use Statement.

It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.

1. The Alpha Mirage® Top Tightening Spinal System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
   a. Patients having fractures of the thoracic and lumbar spine.
   b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
2. The Alpha Mirage® Top Tightening Spinal System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
3. In addition, the Alpha Mirage® Top Tightening Spinal System, when used as a pedicle screw fixation system is intended for:
   a. Patients receiving only autogenous bone graft.
   b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
4. The Alpha Mirage® Top Tightening Spinal System, when used as a laminar hook and bone screw system is intended for:
   a. Patients having fractures of thoracic and lumbar spine.
   b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

The Alpha Mirage® Top Tightening Spinal System is a spinal fixation system comprised of various types and sizes of components that are implanted via a posterior surgical approach and assembled to create a spinal construct. Like most other posterior spinal fixation systems, the Alpha Miraqe® Top Tightening Spinal System is comprised of 1) bone screws and hooks for attachment to the spine, 2) longitudinal rods that are attached to the bone screws and hooks directly/indirectly by means of lateral connectors, and that transmit loads across the pathologic segments of the spine, and 3) optional transverse connecting elements that link the two longitudinal rods for added construct stability.

The purpose of this 510(k) is to provide for commercially pure titanium rods, which allows surgeons to manipulate the rod prior to implantation without compromising the structural strength of the construct.

The provided text describes a 510(k) summary for the Alpha Mirage® Top Tightening Spinal System. It details the device's description, intended use, indications for use, and a comparison to a predicate device. The primary purpose of this 510(k) is to introduce commercially pure titanium rods as part of the system.

However, the document does not describe an AI/ML device, nor does it contain information relevant to AI/ML acceptance criteria or studies. Instead, it discusses the substantial equivalence of device components (titanium rods) to previously cleared components through mechanical and dynamic testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies that prove an AI/ML device meets them based on the provided text. The document is for a traditional medical device (spinal fixation system) and its performance data refers to mechanical and biocompatibility testing, not AI/ML model performance.

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It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.

1. The Alpha Mirage® Top Tightening Spinal System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
   a. Patients having fractures of the thoracic and lumbar spine.
   b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, deqenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
2. The Alpha Mirage® Top Tightening Spinal System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumore and failed previous fusion (pseudoarthrosis).
3. In addition, the Alpha Mirage® Top Tightening Spinal System, when used as a pedicle screw fixation system is intended for:
   a. Patients receiving only autogenous bone graft.
   b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
4. The Alpha Mirage® Top Tightening Spinal System, when used as a laminar hook and bone screw system is intended for:
   a. Patients having fractures of thoracic and lumbar spine.
   b. Patients having thoracolumbar deformity (i.e., idioscoliosis, · neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

The Alpha Mirage® Top Tightening Spinal System is a spinal fixation system comprised of various types and sizes of components that are implanted via a posterior surgical approach and assembled to create a spinal construct. Like most other posterior spinal fixation systems, the Alpha Mirage® Top Tightening Spinal System is comprised of 1) bone screws and hooks for attachment to the spine, 2) longitudinal rods that are attached to the bone screws and hooks directly/indirectly by means of lateral connectors, and that transmit loads across the pathologic segments of the spine, and 3) optional transverse connecting elements that link the two longitudinal rods for added construct stability.

The provided text is a 510(k) summary for a medical device (spinal system) and letters from the FDA. It does not contain information about the acceptance criteria or a study proving the device meets those criteria, particularly in the context of AI/software performance or diagnostic accuracy.

The "Performance Data" section ([1] on page 2) explicitly states: "Mechanical and dynamic testing of the Alpha Mirage® Top Tightening Spinal System constructs was performed as described in 510(k) applications K951846 and K930515. The test results demonstrated that the mechanical performance and biocompatibility characteristics are at least comparable to, if not better than, those of the predicate device."

This indicates that the "performance data" refers to mechanical and biocompatibility testing for a physical spinal implant system, not a software device or AI algorithm with performance metrics like sensitivity, specificity, or AUC. The FDA letter ([2] on page 2) also classifies the device under regulations for physical spinal fixation devices, not software as a medical device.

Therefore, I cannot provide the requested information. The document does not describe:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or software function.
2. Sample size used for a test set, data provenance, ground truth establishment, or expert involvement for AI/software evaluation.
3. Any information about MRMC comparative effectiveness studies or standalone algorithm performance.

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