(218 days)
The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 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.
In addition, the Fortex Pedicle Screw System is 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 purpose of this 510(k) submission is to add rods made of a different material to the Fortex Pedicle Screw System. The modified system has the same intended use and fundamental scientific technology as the previously-cleared Fortex Pedicle Screw System.
Both the modified and predicate Fortex Pedicle Screw System consist of various screws, rods, and cross bar connectors that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion.
The components of the predicate Fortex.Pedicle Screw System are fabricated from medical grade titanium alloy per ASTM F136. The modified system includes components fabricated from medical grade cobalt chrome alloy per ASTM F1537, in addition to the titanium components. As documented within this premarket notification, the addition of cobalt chrome alloy rods does not raise new issues of safety or effectiveness. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.
The provided text describes a 510(k) submission for the Fortex Pedicle Screw System, specifically focusing on the addition of rods made from a different material (cobalt chrome alloy). The submission aims to demonstrate substantial equivalence to a predicate device.
Crucially, this document does not contain information about acceptance criteria for a device performance study in the way you've outlined, nor does it detail a study that proves the device meets such criteria in terms of clinical outcomes or diagnostic accuracy.
Instead, the performance data presented is for non-clinical mechanical testing to demonstrate the structural integrity and comparability of the modified device components.
Here's a breakdown based on the information available and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Note: This table reflects mechanical performance, not clinical or diagnostic performance criteria as typically found in studies for AI/diagnostic devices.
| Acceptance Criterion (Mechanical) | Reported Device Performance (Summary) |
|---|---|
| Static Axial Compression Bending per ASTM F1717 | Similar to predicate system |
| Dynamic Axial Compression Bending per ASTM F1717 | Similar to predicate system |
| Static Torsion Tests per ASTM F1717 | Similar to predicate system |
| Functioning as intended | Modified device functioned as intended |
| Substantial equivalence to predicate devices (mechanical properties) | Observed test results demonstrate substantial equivalence to predicate devices |
Information Not Found in the Provided Text:
The following points are pertinent to studies of diagnostic or AI-driven medical devices, but are not applicable to this 510(k) submission, which focuses on a change in material for a spinal implant system. Therefore, the requested information for these points is not available in the provided text.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. The "test set" here refers to physical components for mechanical testing, not patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. Ground truth for mechanical testing is based on engineering standards and measurements, not expert consensus on medical images or diagnoses.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable to mechanical testing.
- 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 spinal implant, not an AI or diagnostic device designed to assist human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a spinal implant, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" is derived from the physical properties and performance metrics defined by ASTM F1717 standards.
- The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study (Mechanical Testing):
The study involved non-clinical performance testing of the Fortex Pedicle Screw System. This included static and dynamic axial compression bending and static torsion tests. The tests were conducted according to ASTM F1717 standards. The performance of the modified system (with cobalt chrome alloy rods) was compared to the predicate system. The results demonstrated that the modified device functioned as intended and showed substantial equivalence in mechanical properties to the predicate devices. The purpose was to demonstrate that adding a new material (cobalt chrome alloy) for the rods does not introduce new safety or effectiveness concerns, and that its mechanical performance is comparable to an already cleared device.
§ 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.