(62 days)
The OsseoScrew™ System (for use with the Zodiac™ Spinal Fixation System and Illico™ MIS Posterior Fixation System) is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The OsseoScrew is a pedicle screw system that consists of pedicle screws and associated general instruments. Implant components are available in a variety of sizes to suit the individual pathology and anatomical conditions of the patient.
The subject cannulated polyaxial pedicle screws are in diameters of 6.5mm and 7.5mm with lengths ranging from 40 to 55mm. The OsseoScrew is designed to connect to 5.5mm diameter rods and the associated components contained within the Zodiac Spinal Fixation System and the Illico MIS Posterior Spinal Fixation Systems.
The Alphatec Spine OsseoScrew System is an implantable pedicle screw device whose core is manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and the expandable screw shank is manufactured from CP2 Titanium conforming to ASTM F67 which are both industry recognized standards.
The provided text is a 510(k) summary for the Alphatec Spine, Inc. OsseoScrew System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance data and engineering analysis. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information related to human performance, ground truth establishment, or sample sizes beyond the general statement that "Clinical data on the subject device has been provided to support a substantial equivalence determination."
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information regarding sample sizes for training/test sets, data provenance, expert adjudication, MRMC studies, or standalone algorithm performance, as these details are not present in the provided document.
The document focuses on demonstrating substantial equivalence through:
- Technological Comparison: Comparing intended use, indications for use, design, function, and technology to predicate devices.
- Performance Data and Engineering Analysis: Mentioning static shank torsion, static shank tensile, dynamic shank bending, dynamic construct compression, and static construct compression testing.
- Clinical Data: Stating that clinical data was provided to support substantial equivalence.
Without further information about the specific "Clinical data" and "Performance data" mentioned, it's impossible to
address most of your questions.
§ 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.