(151 days)
The Spinal Innovations REVOLUTION ™ Spinal Fixation System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the LS-S1 joint; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of a solid fusion mass. When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.
The Spinal Innovations REVOLUTION ™ Spinal Fixation System is a pedicle screw system 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).
When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the Spinal Innovations REVOLUTION ™ Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degencration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the Spinal Innovations REVOLUTION ™ Spinal Fixation System are intended for sacral/iliac attachment only. Hooks and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. The levels of use for hook and sacral screw fixation of this system are TI to the sacrum.
The Spinal Innovations REVOLUTION ™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes fixed and polyaxial screws of varying diameters and lengths, and hooks in varying designs and lengths, curved and straight rods and transverse connectors.
Here's a breakdown of the acceptance criteria and study information for the Spinal Innovations REVOLUTION™ Spinal Fixation System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biomechanical Performance | Interconnection testing of individual system components | Per ASTM F 1798-97 | "The testing results of the various system components show that the data compares directly to predicate testing and meets or exceeds only predicate device data standards." |
| Biomechanical Performance | Static flexion/extension testing | Not explicitly stated, implied by comparison to predicate devices | "The testing results of the various system components show that the data compares directly to predicate testing and meets or exceeds only predicate device data standards." |
| Biomechanical Performance | Fatigue flexion/extension testing | Not explicitly stated, implied by comparison to predicate devices | "The testing results of the various system components show that the data compares directly to predicate testing and meets or exceeds only predicate device data standards." |
| Overall Equivalence | Material, Design, and Function | Substantially equivalent to predicate devices | "The Spinal Innovations REVOLUTION™ Spinal Fixation System is substantially equivalent in material, design and function to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "various system components" being tested, implying a range of components were subjected to the biomechanical tests.
- Data Provenance: Not explicitly stated. However, given that it's a 510(k) submission for a spinal fixation system, the testing would be conducted in a laboratory setting, likely in the country of origin of the manufacturer (Tennessee, USA). The study is prospective in the sense that the device was manufactured and then tested to demonstrate its performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable to this type of study. The ground truth for this device's acceptance is established through objective, quantitative biomechanical testing against established ASTM standards and comparison to predicate devices, not through expert consensus on qualitative data.
4. Adjudication Method for the Test Set
- Not applicable. See point 3. Biomechanical testing results are objective measurements and do not require adjudication in the same way clinical or imaging studies might.
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
- No, an MRMC comparative effectiveness study was not done. This document describes a biomechanical performance study of a physical medical device (spinal fixation system), not an AI-powered diagnostic or assistive tool for human readers.
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 a software algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- The ground truth used for this device's acceptance is based on objective biomechanical measurements and established engineering standards (ASTM F 1798-97). The device's performance is compared directly against the performance of legally marketed predicate devices, implying that their established performance serves as the "ground truth" for what is considered safe and effective in this context.
8. The Sample Size for the Training Set
- Not applicable. This is a biomechanical study, not a machine learning study. There is no "training set" in the context of device performance testing through physical measurements.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
§ 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.