(325 days)
The Eminent Spine 3D Titanium Pedicle Screw System is designed to provide immobilization and stabilization to the thoracic, lumbar and sacral spinal segments as an adjunct to fusion. The system is intended for posterior, pedicle fixation in skeletally mature patients for the treatment of the following acute and chronic instabilities or deformities: severe spondylolisthesis (grades 3 or 4) of the L5-S1 vertebrae, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis and failed previous fusion.
The Eminent Spine 3D Titanium Pedicle Screw System consists of rods, polyaxial screws with set caps, and cross connectors with lock screws. Rods are 5.5mm in diameter and are available either straight or pre-contoured. Straight and pre-contoured rods are each offered in lengths ranging from 40mm to 600mm in various increments. The radius of curvature of the pre-contoured rods is 154mm throughout the entire series. Cannulated polyaxial screws are available in 6.0mm, 6.5mm, 7.0mm, 7.5mm, and 8.0mm diameters and in lengths ranging from 40mm to 60mm in 5mm increments. Set caps are used to fasten the rod and screw. Cross connectors are available in 3 length ranges: 32mm-42mm, 42mm-58mm, and 58mm-74mm. Cross connectors lock screws are used to fasten the cross connector together and fasten across the rods.
All components are manufactured from Ti6Al4V ELI. The screw is made specifically from Ti6Al4V ELI per ASTM F3001 and the tulip, set cap, rod, and cross link systems are made specifically from Ti6Al4V ELI per ASTM F136. The devices are sold non-sterile.
The provided document is an FDA 510(k) clearance letter for a medical device, the "Eminent Spine 3D Titanium Pedicle Screw System." This letter is a regulatory document, not a clinical study report.
Therefore, none of the information requested about acceptance criteria and study proving device performance (points 1-9) can be found in this document.
The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance. This equivalence is primarily demonstrated through mechanical testing (listed on page 6) and comparison of technological characteristics (page 6), rather than clinical performance studies involving human subjects or AI algorithms.
Specifically, the document mentions:
- Mechanical Testing:
- Static torsion, static compression bending, and dynamic compression bending according to ASTM F1717
- Torsional strength, driving torque, and axial pullout according to ASTM F543
- Static cantilever bending according to ASTM F2193
- Dynamic cantilever bending modified from ASTM F2193
- Conclusion: "The results support the substantial equivalence of the subject device compared to predicate devices."
This type of submission typically relies on non-clinical data (e.g., bench testing) to demonstrate that the new device performs as safely and effectively as a legally marketed predicate device, and does not usually include the detailed clinical study data points requested (such as sample size for test/training sets, expert adjudication, MRMC studies, or AI algorithm performance).
In summary, the provided text does not contain the information necessary to address the specific questions about acceptance criteria and clinical study performance for human readers or AI, as it pertains to a mechanical medical device cleared through substantial equivalence based on bench testing.
§ 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.