(39 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 treatment of 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 NuVasive® Precept™ Spinal 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 Nu Vasive 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
- Pseudoarthosis
- Tumor resection and/or
- Failed previous fusion
The NuVasive Precept Spinal System consists of a variety of polyaxial screws, reduction screws, offset connectors, rods, locking nuts, and transverse connectors. Implant components 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 for the modification to a component used in the assembly of tulip to screw shanks of polyaxial screws. The system as a whole remains unchanged compared to the predicate (K102514).
The NuVasive® Precept™ Spinal System is a medical device, and the provided text describes its 510(k) summary for premarket notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy in a clinical study with acceptance criteria and statistical analysis as would be typical for a new drug or high-risk medical device.
Therefore, many of the requested elements for a study proving device meets acceptance criteria are not applicable in this context, as a clinical study with human subjects, ground truth, and expert adjudication was not conducted for this 510(k) submission. Instead, the device's performance was evaluated through non-clinical (mechanical) testing.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from predicate or standard) | Reported Device Performance (NuVasive Precept™ Spinal System) |
|---|---|
| Mechanical Testing: | |
| Static and dynamic flexion-extension moment | Met or exceeded the performance of the predicate devices based on ASTM F1798. |
| Tulip pull-off | Met or exceeded the performance of the predicate devices. |
| Tension-torsion | Met or exceeded the performance of the predicate devices. |
| Orbital Tension | Met or exceeded the performance of the predicate devices. |
| Overall Equivalence: | |
| Substantial equivalence to predicate devices | Demonstrated through comparison in design, intended use, material composition, function, and range of sizes. System as a whole remains unchanged compared to the predicate (K102514). |
Note: The specific numerical acceptance criteria (e.g., maximum force, displacement limits) for each mechanical test are not explicitly detailed in the provided summary, only that the device "met or exceeded" the performance of predicate devices or relevant standards (ASTM F1798).
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in the document. For mechanical testing, this would refer to the number of individual components or assembled systems tested.
- Data Provenance: The tests were nonclinical (mechanical) and conducted by NuVasive, Inc. at their facilities, likely in the USA (San Diego, California).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This was a non-clinical, mechanical testing submission. There was no "ground truth" to be established by experts in the context of clinical interpretation or diagnosis. The "ground truth" for mechanical testing is typically defined by engineering standards and specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. As this was mechanical testing, no human adjudication of clinical outcomes or interpretations was performed.
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. No MRMC or clinical comparative effectiveness study involving human readers or AI assistance was performed. This submission is for a physical spinal implant system, not a diagnostic imaging or AI-driven decision support tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This relates to AI/algorithm performance. The NuVasive® Precept™ Spinal System is a physical medical device (pedicle screw system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Mechanical Testing Standards: For the mechanical tests (static/dynamic flexion-extension, tulip pull-off, tension-torsion, orbital tension), the "ground truth" or reference for performance is established by industry standards (e.g., ASTM F1798) and the performance of the predicate devices. The goal was to show that the modified device's performance was equivalent to or better than these established benchmarks.
8. The sample size for the training set
- Not applicable. There was no "training set" as this was a non-clinical mechanical testing for a spinal implant, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. As there was no training set, this question does not apply.
§ 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.