(150 days)
The REVERE® Stabilization System, when used as a posterior 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: deqenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
In addition, the REVERE® Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or illum with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used as a posterior non-pedicle screw fixation system, the REVERE® Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudoarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.
When used as an anterolateral thoracolumbar system, the REVERE® Stabilization System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
The REVERE® Stabilization System consists of rods, hooks, monoaxial screws, uniplanar screws, polyaxial screws; reduction screws, locking caps, t-connectors, offset housing clamps, head offset connectors, trans-iliac connectors, sacral plates, staples, and associated manual surgical instruments. Screws and rods are available in a variety of sizes to accommodate individual patient anatomy. REVERE® implants mate with 5.5mm diameter rods; REVERE® 6.35 implants mate with 6.35mm diameter rods. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and t-connectors are intended for posterior use only. Staples are intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod, trans iliac connectors and sacral plates.
The most common use of this screw, hook, and rod system in the posterior thoracolumbar and sacral spine is two rods, each positioned and attached lateral to the spinous process via pedicle screws and/or lamina, pedicle or transverse process hooks.
The most common use of this screw, hook, and rod system in the anterior thoracolumbar spine is one rod, positioned and attached to the vertebral bodies via monoaxial screws through an appropriate size staple.
Screws and hooks attach to the rods using a locking cap with an inner set screw. The size and number of screws are dependent on the length and location of the rod. Screws are inserted into a pedicle of the thoracolumbar and/or sacral spine. The type and number of hooks are also dependent on the location in the spine needing correction and/or stabilization. Hooks are attached to the laminae, pedicles, or transverse process of the posterior spine.
T-connectors are modular components designed to connect the two rods of a construct and act as a structural cross member. The rod-clamping set screws secure the t-connectors to the rods. Additional set screws secure the adjustable cross members at the desired length. T-connectors from the PROTEX® system may be used with 6.5mm, 6.0mm or 5.5mm rod systems. REVERE® tconnectors may only be used with 5.5mm rods; REVERE® 6.35 t-connectors may only be used with 6.35mm rods. Additional connectors may be used to connect two rods, and are also secured using set screws.
REVERE® hooks and t-connectors, and 5.5mm diameter rods may be used with the BEACON® Stabilization System.
REVERE® screws and locking caps may be used with the TRANSITION® Stabilization System. Specifically, REVERE® polyaxial (solid, cannulated and dual outer diameter) screws and monoaxial screws 6.5mm diameter and larger, and 35mm length and larger, may be used with the TRANSITION® implant assemblies.
The rods are composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, Chroman mory and F138 and F138. All other REVERE® implants are composed of titanium alloy or stainless steel, as specified in ASTM F136, F1295, F67 and F138. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium-molybdenum alloy implants.
This document, K103072, pertains to a 510(k) premarket notification for the "REVERE® Sacral Plates" by Globus Medical Inc. It is a submission to add these sacral plates to the existing REVERE® Stabilization System.
The information provided focuses on the mechanical testing of the device to demonstrate substantial equivalence to predicate devices, rather than a study proving clinical effectiveness based on performance criteria like accuracy, sensitivity, or specificity that would involve human subjects or expert assessment.
Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set details) are not applicable in this context, as this is a device clearance based on engineering and performance testing.
Here's a breakdown of the available information:
Acceptance Criteria and Device Performance (K103072: REVERE® Sacral Plates)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance and Compliance |
|---|---|---|
| Mechanical Performance | - Static and Dynamic Compression (in accordance with ASTM F1717) | - Mechanical testing (static and dynamic compression) was conducted. |
| - Static Torsional testing (in accordance with ASTM F1717) | - Mechanical testing (static torsional) was conducted. | |
| - Compliance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 | - Testing was conducted in accordance with this guidance document. | |
| Substantial Equivalence | - Technical characteristics similar to predicate device(s). | - The REVERE® Sacral Plate implants are similar to the predicate REVERE® Stabilization System implants with respect to technical characteristics. |
| - Performance similar to predicate device(s). | - Performance data demonstrate substantial equivalence to the predicate device. | |
| - Intended use similar to predicate device(s). | - The REVERE® Sacral Plate implants are similar to the predicate REVERE® Stabilization System implants with respect to intended use. The submission supports substantial equivalence to the predicate device(s). | |
| Materials | - Rods composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel (as specified in ASTM) | - Rods are composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F67 and F138. |
| - All other implants composed of titanium alloy or stainless steel (as specified in ASTM) | - All other REVERE® implants are composed of titanium alloy or stainless steel, as specified in ASTM F136, F1295, F67 and F138. | |
| - Avoidance of galvanic corrosion risk (stainless steel not connected to titanium, titanium alloy, or cobalt chromium-molybdenum alloy) | - Statement indicating this risk and the requirement that "stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium-molybdenum alloy implants." This is a design/usage constraint, not a test result. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not applicable in the context of mechanical testing. The testing would have involved a sufficient number of device samples (parts/components) to satisfy the requirements of the ASTM standards, but this is not typically reported as a "sample size" in the way it is for clinical or AI performance studies.
- Data Provenance: Not applicable. The data is derived from in vitro mechanical testing performed in a laboratory setting, not from human subjects or clinical data from a specific country or time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This submission relies on engineering standards (ASTM F1717) and FDA guidance for spinal systems. "Ground truth" in the sense of expert consensus on clinical findings is not relevant here. The "ground truth" is defined by the physical properties and performance parameters specified in the engineering standards.
4. Adjudication Method for the Test Set
- Not applicable. There was no human expert adjudication of performance data in the clinical or image analysis sense. Compliance is determined by whether the engineering test results meet the predefined thresholds of the ASTM standards and FDA guidance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not a study assessing human reader performance with or without AI assistance. It's a mechanical performance study for a medical implant device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This is not an algorithmic or AI-based device. Performance is assessed through mechanical testing of the physical implant components.
7. The Type of Ground Truth Used
- Engineering Standards and Predicate Device Performance. The "ground truth" for the REVERE® Sacral Plates is the established performance benchmarks set by the ASTM F1717 standard and the performance characteristics of the legally marketed predicate devices (REVERE® Stabilization System K061202, K091782, K093294). The device must perform comparably or better according to these established engineering and safety standards.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no "training set" or corresponding ground truth for an AI system.
§ 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.