(94 days)
When used as a pedicle screw fixation system, the NuVasive Precept Spinal 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)
The Nu Vasive Precent Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-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 of a solid fusion.
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Precept Spinal 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
- Pseudoarthrosis
- Tumor resection and/or
- Failed previous fusion
When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Precept Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the NuVasive Precept Spinal 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 limited to a posterior approach and is intended to be used with autograft and/or allograft.
The NuVasive Precept Spinal System is a pedicle screw system that consists of various screws, lock screws, rods, and associated general instruments. The Precept Spinal System offers a variety of components to suit the individual pathology and anatomical conditions of the patient. The purpose of this 510(k) submission is to introduce a sterile option for the implants and expanded the indications for use to include the treatment of adolescent idiopathic scoliosis.
The provided text is related to a 510(k) premarket notification for the NuVasive® Precept™ Spinal System. This document focuses on demonstrating substantial equivalence to predicate devices based on design, material, function, and performance data from nonclinical testing. It explicitly states that nonclinical testing was performed.
Therefore, the study described does not involve any human-in-the-loop performance, expert ground truth labeling, or a test set of patient data. Consequently, the requested information regarding acceptance criteria for device performance in a clinical setting, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document.
The document details the following performance data, all nonclinical:
1. Acceptance Criteria and Reported Device Performance (Nonclinical Testing):
| Performance Attribute | Acceptance Criteria | Reported Device Performance (as stated in document) |
|---|---|---|
| Static Compression Bending | Per ASTM F1717 | Demonstrated substantial equivalence to predicate device. |
| Static Torsion | Per ASTM F1717 | Demonstrated substantial equivalence to predicate device. |
| Dynamic Compression Bending | Per ASTM F1717 | Demonstrated substantial equivalence to predicate device. |
| Static Tulip Pull-off | Per ASTM F1798 | Demonstrated substantial equivalence to predicate device. |
2. Sample size used for the test set and the data provenance: Not applicable. The provided document details nonclinical, mechanical testing, not a study involving patient data or a test set in the context of AI/algorithm performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant for the nonclinical testing described.
4. Adjudication method for the test set: Not applicable.
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 study was not done. This document describes nonclinical mechanical testing, not a clinical study involving human readers or AI.
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. The device is a spinal implant system, not a software algorithm.
7. The type of ground truth used: Not applicable in the context of clinical/AI studies. For the nonclinical tests, the "ground truth" would be the established engineering standards (ASTM F1717, ASTM F1798) and the performance of the predicate device.
8. The sample size for the training set: Not applicable. There is no training set mentioned as 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.