(115 days)
The Revolution™ Spinal Fixation System is intended for pedicle screw fixation of the noncervical, posterior spine in order 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: (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 previously cleared 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 standard (one level) 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. 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. To allow for multiple level fusions, four additional components were added to the system (K160216): 1) Transition Bone Screws, 2) Transition Connectors, 3) Two-Post Connectors, and 4) Two-Post Bone Screws. These components provide two connector attachment posts with a single bone screw, which allows the attachment of two connectors (one superior, one inferior) to a single level of the spine. In the case of the Transition Connector, the Transition Bone Screw includes a connector attachment post. This 510(k) submission adds two types of components to the system: 1) Two-Level Connectors, and 2) Two-Level Bone Screws. These components, when utilized with the previously cleared, standard Revolution™ connectors and standard bone screws, allow stabilization of two levels of the spine. These new Two-Level components allow fusion of two spinal levels when the patient's inter-pedicular distances are very short, by allowing attachment of two connector interfaces to a single bone screw. Like the previously cleared Revolution™ bone screws, the Two-Level Bone Screws are available in diameters of 4.5 mm - 7.5 mm, and in lengths from 25 mm to 55 mm. All screw diameter sizes except for the 4.5mm are cannulated for use with a 1.4 mm k-wire. The Two-Level Bone Screws have a standard thread for interfacing bone and a partially threaded post designed to engage a standard (one level) connector and a Two-Level Connector. The Two-Level Connector uses the same technology (the pivoting-slide and the spherical bearing), and has a stepped central plate. The step in the plate allows two connectors to stack on top of each other, thus requiring less horizontal space to attach two connectors. All implant components of the Revolution™ Spinal Fixation System, including the additional components, are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.
This document refers to the Revolution™ Spinal Fixation System which is a medical device, and therefore the "device performance" mentioned in the request refers to the structural and mechanical performance of the system rather than diagnostic accuracy.
Here's a breakdown of the requested information based on the provided text, focusing on the mechanical performance as that's what was evaluated for this device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM F1798-13: Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants | The testing revealed that the mechanical properties of the additional Two-Level components are comparable to existing Revolution™ Spinal Fixation System components and to published values for rod systems. |
| ASTM F1717-15: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model (Including Static Compression Bending, Static Torsional Bending, and Dynamic Compression Bending) | The testing revealed that the mechanical properties of the additional Two-Level components are comparable to existing Revolution™ Spinal Fixation System components and to published values for rod systems. |
| Pyrogenicity requirements | Pyrogen testing of Revolution Spinal System components has shown that the implants conform to pyrogen requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of devices tested) for the mechanical performance tests. It mentions "testing was conducted" but no specific count of components or systems tested.
- Data Provenance: Retrospective, as the testing was conducted on samples of the device to demonstrate their properties. The origin of the data is from the manufacturer's internal testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable for this type of device and study. The ground truth for mechanical testing is established by recognized international standards (ASTM F1798-13 and ASTM F1717-15), not human expert consensus on images or outcomes.
4. Adjudication Method for the Test Set
Not applicable. Mechanical testing results are objective measurements against defined standard criteria, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is for evaluating observer performance, typically in diagnostic imaging, which is not relevant for this spinal fixation system, whose performance is determined by mechanical properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm or software. Its performance is entirely standalone in terms of its mechanical function without human interpretation.
7. The Type of Ground Truth Used
The ground truth used for evaluating the device's performance was the established criteria and methodologies outlined in the ASTM F1798-13 and ASTM F1717-15 standards, along with pyrogenicity requirements. These standards define the expected static and dynamic mechanical properties (e.g., strength, bending, torsional resistance) for spinal implants.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a physical medical 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.