(62 days)
When used as a pedicle screw fixation system, the NuVasive® Reline® System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Degenerative spondylolisthesis with objective evidence of neurologic impairment
- Fracture
- Dislocation
- Scoliosis
- Kyphosis
- Spinal tumor and/or
- Failed previous fusion (pseudoarthrosis)
When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the NuVasive Reline System is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is linited to a posterior approach and is intended to be used with autograft and/or allograft.
The NuVasive Reline 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 System is also intended for the following indications:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Spinal stenosis
- Spondylolisthesis
- Spinal deformities
- Fracture
- Pseudoarthosis
- Tumor resection and/or
- Failed previous fusion
In order to achieve additional levels of fixation, the Reline System rods may be connected to the Armada System.
The NuVasive Reline System is a pedicle screw system that consists of a variety 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. The purpose of this 510(k) is to add new fenestrated screws, and larger diameter uniplanar screw components to the Reline System.
The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.
Here's an analysis of the provided text regarding the NuVasive® Reline® System, focusing on acceptance criteria and study details.
Based on the provided FDA 510(k) summary for the NuVasive® Reline® System (K160989), the device is a pedicle screw spinal system. The submission is for an update to an existing system, specifically adding "new fenestrated screws, and larger diameter uniplanar screw components" to the Reline System.
Crucially, this document describes a submission for a Class III Medical Device seeking substantial equivalence (510(k) clearance) to predicate devices. For this type of submission, the primary aim is to demonstrate that the new device or modified components are as safe and effective as a legally marketed predicate device. This is typically achieved through nonclinical (benchtop) testing rather than human clinical trials that establish explicit acceptance criteria based on performance endpoints like sensitivity, specificity, or reader improvement.
Therefore, the structure of the acceptance criteria and study details will differ significantly from what would be expected for, for example, a diagnostic AI device requiring clinical validation with human subjects.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a pedicle screw system, the "acceptance criteria" are not reported as clinical performance metrics (like accuracy for a diagnostic device) but rather as compliance with specific ASTM standards for mechanical testing to demonstrate substantial equivalence. The "reported device performance" is that the device meets these standards relative to the predicate.
| Acceptance Criteria Category | Specific Acceptance Criteria (based on ASTM Standards) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Static Compression Bending per ASTM F1717-09 | Results demonstrate substantial equivalence to the predicate. |
| Static Torsion per ASTM F1717-09 | (Implies that the device performed comparably or better than predicate within the specified standards) | |
| Dynamic Compression Bending per ASTM F1717-09 | ||
| Static Tulip Pull-off (Screw-head to Rod connection) per ASTM F1798-13 | ||
| Design & Materials | Engineering Rationales (supporting design and material choices as equivalent) | Results demonstrate substantial equivalence to the predicate. |
Note: The specific numerical thresholds or performance ranges for "acceptance" within each ASTM standard are not detailed in this summary document but would be part of the full testing report submitted to the FDA. The summary states that the results "demonstrate that the subject NuVasive Reline System is substantially equivalent to the predicate."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of this 510(k) summary as it describes mechanical benchtop testing, not human-subject or patient data for a "test set." The "sample size" would refer to the number of devices or components tested for each mechanical test. This detail is not provided in the summary but would be in the full test reports.
- Data Provenance: Not applicable for mechanical benchtop testing. The tests are conducted in a laboratory setting. There is no mention of country of origin for data or whether it's retrospective/prospective clinical data because a clinical study of this nature was not performed for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For mechanical testing of pedicle screw systems, "ground truth" is established by the specified ASTM standards and objective physical measurements rather than expert consensus on clinical findings.
- Qualifications of Experts: Not applicable. The "experts" involved would be engineers and lab technicians experienced in conducting and interpreting mechanical tests according to ASTM standards.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring adjudication of findings by experts was conducted.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data. The NuVasive Reline System is an implantable surgical hardware device.
- Effect Size of Human Readers Improvement: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance Study: No, this is not applicable. The device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the nonclinical performance data, the "ground truth" is defined by the established and recognized industry standards (ASTM F1717 and ASTM F1798) for spinal implant mechanical testing. Compliance with these standards, and demonstration of substantial equivalence to predicate devices, forms the basis of the acceptable performance.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This refers to training data for machine learning algorithms, which is not relevant for this device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. No training set for an algorithm was used.
Summary of Device and Approval Context:
The NuVasive® Reline® System is a Class III Pedicle Screw Spinal System. The 510(k) (K160989) detailed here is for modifications to an already cleared system (predicate device Reline System K143689). The specific modifications are the addition of "new fenestrated screws, and larger diameter uniplanar screw components."
The approval process for this type of device, especially for modifications seeking substantial equivalence, primarily relies on benchtop mechanical testing to demonstrate that the new components meet established safety and performance standards (ASTM) and are comparable to predicate devices in terms of design, materials, and function. The document explicitly states: "Nonclinical testing was performed to demonstrate that the subject NuVasive Reline System is substantially equivalent to the predicate 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.