(83 days)
The Arsenal Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion 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; pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congental scoliosis. Additionally, the Arsenal Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatic pedicle screw fixation is limited to a posterior approach.
The Arsenal Spinal Fixation System is intended to be used with autograft and/or allograft.
The Arsenal Spinal Fixation System is a posterior, non-cervical, spinal fixation system consisting of a variety of shapes and sizes of rods, screws, bridges and connectors to provide temporary internal fixation and stabilization during bone graft healing as an adjunct to fusion of the thoracic, lumbar and sacral spine.
The purpose of this Traditional 510(k) Premarket Notification is to add deformity implants to the currently marketed Arsenal Spinal Fixation System and expand the current pediatric indication of the Arsenal System to include treatment of progressive spinal deformities.
The provided text is a 510(k) premarket notification summary for the Alphatec Spine, Arsenal Spinal Fixation System. This document is a regulatory filing for a medical device and does not describe the acceptance criteria or a study proving the device meets performance claims related to diagnostic accuracy or clinical outcomes.
Instead, it focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that their device is as safe and effective as a legally marketed device that FDA has already approved. The "performance data" mentioned refers to mechanical and engineering tests, not clinical studies in the typical sense of evaluating diagnostic performance or clinical improvement in patients.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, or MRMC studies. The document simply does not contain this type of information.
The only "performance data" mentioned is:
- ASTM F1717 Static Compression Bending Test
- Dynamic Compression Bending Test
- Static Torsion Tests
- ASTM F1798 Static Flexion-Extension Moment (My) and Axial Gripping Capacity (FX)
- Axial & Maximum Angle Screw Body Pulloff Testing
These are biomechanical tests to assess the physical properties and strength of the spinal fixation system components. The "acceptance criteria" for these tests would typically be compliance with the standards (e.g., passing limits defined in the ASTM standards), but the specific numerical criteria and results are not provided in this summary.
In summary, the provided document does not contain the information required to populate the requested table and details about a study demonstrating device performance in a clinical or diagnostic context.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.