(55 days)
When used as a pedicle screw fixation system, the NuVasive® 4.5-5.0 System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Degenerative spondylolisthesis with objective evidence of neurologic impairment 3. Fracture 4. Dislocation 5. Scoliosis 6. Kyphosis 7. Spinal tumor and/or 8. Failed previous fusion (pseudoarthrosis) The NuVasive Reline 4.5-5.0 System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion. When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Reline 4.5-5.0 System is also intended for the following indications: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Spinal stenosis 3. Spondylolisthesis 4. Spinal deformities 5. Fracture 6. Pseudoarthosis 7. Tumor resection and/or 8. Failed previous fusion When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline 4.5-5.0 System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the NuVasive Reline 4.5-5.0 System is intended to treat pediatic patients diagnosed with the following conditions: spondylolysis, and fracture caused by turnor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft. In order to achieve additional levels of fixation, the NuVasive Reline 4.5-5.0 System rods may be connected to the Reline System.
The NuVasive Reline 4.5-5.0 System is a pedicle screw system that consists of a varietv screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.
This document is a 510(k) premarket notification for the NuVasive Reline 4.5-5.0 System, a pedicle screw system. It states that the device is substantially equivalent to legally marketed predicate devices. The information provided focuses on demonstrating this equivalence through non-clinical performance testing rather than clinical studies or AI-driven performance.
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1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Result) |
|---|---|
| Static Compression Bending (per ASTM F1717) | Results demonstrate that the subject device is substantially equivalent to the predicate. |
| Static Torsion (per ASTM F1717) | Results demonstrate that the subject device is substantially equivalent to the predicate. |
| Dynamic Compression Bending (per ASTM F1717) | Results demonstrate that the subject device is substantially equivalent to the predicate. |
| Static Tulip Pull-off (per ASTM F1798) | Results demonstrate that the subject device is substantially equivalent to the predicate. |
| Design, Labeling/Intended Use, Material Composition, Function | The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison. |
Important Note: The document confirms that "demonstrate that the subject NuVasive Reline 4.5-5.0 System is substantially equivalent to the predicate device." However, it does not provide specific numerical values for the acceptance criteria (e.g., minimum bending strength in Nm) or the numerical performance results of the NuVasive Reline 4.5-5.0 System or its predicate for direct comparison. It only states that the results show substantial equivalence.
2. Sample Size Used for the Test Set and the Data Provenance
The study described is non-clinical performance testing of a physical medical device (pedicle screw system), not an AI/software device involving data sets, patients, or human readers. Therefore:
- Sample Size for Test Set: This information is not provided as the tests are for mechanical properties of the device components. The ASTM standards typically specify the number of samples required for each test.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this involves mechanical testing of physical implants, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth, in the context of expert consensus, is relevant for AI/diagnostic devices interpreting medical images or patient data. This is a physical device subject to mechanical engineering standards.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. Adjudication methods are used to resolve disagreements among human experts in clinical studies, not for non-clinical mechanical testing.
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 the testing of a physical medical implant (pedicle screw system), not an AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This document focuses on the mechanical properties and substantial equivalence of a physical medical device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this type of device is defined by the ASTM standards (ASTM F1717 and ASTM F1798) themselves, which specify the test methodologies and, implicitly, the expected performance characteristics for pedicle screw systems. Substantial equivalence is determined by comparing the new device's performance to that of a legally marketed predicate device under these standardized test conditions.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of mechanical testing for substantial equivalence of a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no training set, there's no ground truth for it to be established.
§ 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.