(96 days)
The Revolution™ Spinal Fixation System is intended for pedicle screw fixation of the noncervical posterior spine in order to provide immobilization 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e., fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.
The Intelligent Implant Systems' Revolution™ Spinal Fixation System consists of monoaxial bone screws of various lengths and diameters and a series of connector assemblies for connecting the bone screws. The Revolution™ Bone Screws have a standard thread for interfacing bone and a partially threaded post designed to engage the Revolution™ Connectors. Screws are available in 4.5mm major diameter and lengths from 25mm to 50mm and 5.5mm, 6.5mm, and 7.5mm major diameters and lengths from 25mm to 55mm. All screw diameter sizes except for the 4.5mm are cannulated for use with a 1.4 mm k-wire. To allow the surgeon to determine the height of the connector relative to the bone, screws with extended non-threaded collars are provided. These extended collars effectively provide built in spacers that prevent the bone screw from being driven too deep and control the overall height of the completed assembly. The Revolution™ Connectors are provided in various lengths and are used to connect the pedicle screws and create a rigid structure. To allow for variation in screw placement, each end of the connector allows for angular compensation. One end allows for full polyaxial angulation, similar to a typical polyaxial screw. The other end has a pivoting-slide that allows for angulation in only one plane along the long axis of the Connector while also sliding within an opening in the Connector. As the distance between two screws is always variable, the slide allows the Connector to compensate for this difference, minimizing inventory and eliminating the need to cut spinal rods. In addition, the Connectors have a threaded locking nut built into each end and each nut fits over the top of a bone screw post. These locking nuts are turned clockwise to tighten. A calibrated torque wrench provides the correct setting for locking the nuts on the bone screw post with sufficient force. The system can be unlocked, if necessary, by turning the locking nuts counterclockwise. All implant components of the Revolution™ Spinal Fixation System are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.
This FDA 510(k) summary describes a spinal fixation system, not a device with AI components. Therefore, the questions related to AI performance, ground truth, experts, and training/test sets are not applicable.
The document focuses on the Revolution™ Spinal Fixation System, a mechanical implant. For such a device, acceptance criteria and testing revolve around its physical properties, material compatibility, and structural integrity under simulated physiological conditions.
Here's an analysis of the provided information, addressing the applicable questions and indicating when a question is not relevant to this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the testing was conducted "according to methods defined in ASTM F 1798-13, 'Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants', and ASTM F 1717-14, 'Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model'."
Since specific numerical acceptance criteria (e.g., minimum strength in Newtons) are not explicitly stated in this summary, the table below will reflect the type of tests performed and the general conclusion given in the document. The implicit acceptance criterion is that the device meets the requirements of these ASTM standards and performs comparably to predicate devices.
| Acceptance Criterion (Implicit based on ASTM standards) | Reported Device Performance |
|---|---|
| ASTM F1798-13 Tests: | (Implied to meet standard, comparable to predicate) |
| Static Flexion-Extension Strength | Comparable to published values on plate and rod systems |
| Axial Gripping Strength | Comparable to published values on plate and rod systems |
| Static A-P Pullout Strength | Comparable to published values on plate and rod systems |
| ASTM F1717-14 Tests: | (Implied to meet standard, comparable to predicate) |
| Static Compression Bending | Comparable to published values on plate and rod systems |
| Static Torsional Bending | Comparable to published values on plate and rod systems |
| Dynamic Compression Bending | Comparable to published values on plate and rod systems |
| Material Compatibility: | Complies with ASTM F-136. |
| Material: Ti-6Al-4V ELI |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size used for the test set" in terms of patient data, as this is a mechanical device. Instead, it refers to mechanical testing. The sample size for mechanical testing (i.e., the number of devices or components tested) is not explicitly stated in this summary. The data provenance is mechanical testing conducted in a laboratory setting to validate the device's physical properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is not an AI/diagnostic system. Ground truth in this context refers to the physical properties measured against established engineering standards (ASTM).
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically for clinical studies or AI algorithm outputs where multiple human reviewers assess data. Here, the "truth" is determined by standardized mechanical testing procedures.
5. 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 mechanical spinal fixation system, not an AI or diagnostic device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device does not involve an algorithm.
7. The Type of Ground Truth Used
For this mechanical device, the "ground truth" is defined by established engineering and material standards, specifically:
- ASTM F 1798-13: "Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants"
- ASTM F 1717-14: "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model"
- ASTM F-136: Standard for the Ti-6Al-4V ELI material.
The device's performance is compared against the requirements and typical performance values for devices conforming to these standards.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not have a "training set" in the context of AI.
§ 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.