(170 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. This 510(k) is to introduce sterile packaged implants to the Reline System.
This document is a 510(k) premarket notification decision letter and summary from the FDA for a medical device (NuVasive Reline System), which is a pedicle screw spinal system.
The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than on a traditional study with acceptance criteria and performance metrics for a novel AI/software medical device. As such, many of the requested elements for AI/software studies are not applicable or cannot be extracted from this document.
Here's an attempt to address the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
This document does not present acceptance criteria or reported device performance in the manner typically used for software or AI medical devices (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence through design, materials, and function testing for a mechanical implant.
The performance data mentioned is related to sterilization and packaging validation, which are pass/fail criteria.
| Acceptance Criteria (for the new packaging and sterilization) | Reported Device Performance |
|---|---|
| Gamma sterilization validated | Validated |
| Sterile packaging validated | Validated |
| Integrity of sterile barrier over time validated | Validated |
| Bacterial endotoxin testing passed | Passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The performance data discussed here relates to physical and biological testing of the device and its packaging, not data analysis for an AI or software component. There is no "test set" of patients or data in the context of AI evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/software device evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/software device evaluation.
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 implant, not an AI-assisted diagnostic or treatment planning system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This product is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the sterilization and packaging validation, the "ground truth" would be established by standard microbiological and material science testing protocols and industry best practices for medical device sterilization and sterile barrier integrity.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
§ 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.