(75 days)
When used as a pedicle screw fixation system, the Nu Vasive 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: (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).
When used for posterior non-cervical screw fixation in pediatric patients, the 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: spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma. Pediatic pedicle screw fixation is limited 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: (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.
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 expand the indications for use to include treatment of adolescent idiopathic scoliosis.
This document is a 510(k) premarket notification for the NuVasive Reline System. It is a submission to the FDA for a medical device, which means it addresses substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a study. Therefore, most of the information requested in your prompt regarding acceptance criteria and a study to prove performance is not applicable to this type of document.
The document primarily focuses on establishing substantial equivalence based on design, intended use, materials, and technological characteristics compared to existing cleared devices, not on presenting novel performance data from an independent study specifically for this device.
Here's a breakdown based on the provided text, indicating why certain requested information is not available:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document does not present acceptance criteria for a new device's performance nor does it report specific performance outcomes from a study on the NuVasive Reline System itself. It asserts substantial equivalence to predicate devices, meaning it is expected to perform comparably to already cleared devices.
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. No new performance testing or clinical studies are reported for the NuVasive Reline System in this submission. Therefore, there is no "test set" or associated data described.
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. As no new performance testing data is presented, there is no "ground truth" establishment process for a test set described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Again, no test set or performance evaluation requiring adjudication is presented in this document.
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 device is a spinal fixation system (pedicle screw system), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a hardware medical device, not an algorithm or software. "Standalone performance" in the context of an algorithm is not relevant here.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. No new clinical or performance data requiring ground truth is presented for the NuVasive Reline System. The "ground truth" in this context refers to the established safety and effectiveness of the predicate devices to which the NuVasive Reline System is compared.
8. The sample size for the training set
- Not Applicable. As this is a hardware device submission, not an AI/ML algorithm, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. There is no training set for this device.
Summary from the document relevant to performance/equivalence:
- G. Performance Data: "No new performance testing was performed. Comparison to the predicate devices was provided to support substantial equivalence."
- H. Conclusions: "The subject NuVasive Reline System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use."
The document states that substantial equivalence was demonstrated through comparison in areas including design, labeling/intended use, material composition, and function to its predicate devices (Arsenal Spinal Fixation System K133221 and GSB Global Spinal Balance System K132014), not through new performance studies specific to the NuVasive Reline System.
§ 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.