(152 days)
When used as a pedicle screw fixation system, the NuVasive 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 spinc: (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).
The NuVasive 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 (1.3 to sacrum), with removal of the implants after attainment of a solid fusion.
When used as an anterolateral non-nedicle screw system in the thoracic and lumbar spine. the NuVasive Spinal System is also intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degencration 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 Spinal System consists of a variety of polyaxial screws, fixed angle screws, 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 document describes a 510(k) premarket notification for the NuVasive Spinal System, a medical device. The information provided in the input is insufficient to complete the requested table and details regarding acceptance criteria and a study proving the device meets those criteria.
Here's why and what information is missing:
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Acceptance Criteria and Device Performance: The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It states, "Mechanical testing was presented," but does not provide any specific acceptance criteria (e.g., strength, fatigue life, displacement limits) nor the quantitative results of these tests (the reported device performance). Without this data, a table like the one requested cannot be constructed.
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Study Details (Sample Sizes, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone): The document explicitly states, "Summary of Clinical Tests (Not Applicable)." This means no clinical studies were performed to demonstrate the safety and effectiveness of the device. The 510(k) pathway for this device relies on demonstrating substantial equivalence through mechanical testing and comparison to predicate devices, not clinical performance data from human subjects.
Therefore, the requested information for acceptance criteria and the study that proves the device meets them cannot be extracted from the provided text.
However, I can explain the general context based on the provided document:
General Device Type and Approval Process:
- The NuVasive Spinal System is a spinal implant for fixation and stabilization of spinal segments.
- It's a Class III device (Pedicle Screw Spinal System).
- It was cleared via a 510(k) premarket notification (K033546), signifying that the FDA determined it is "substantially equivalent" to predicate (already legally marketed) devices. This means it has the same intended use, technological characteristics, and raises no new safety or effectiveness concerns as the predicate device(s).
What a 510(k) submission typically entails for this type of device (though specific details are not in the provided text):
For a spinal implant, "acceptance criteria" and "device performance" in a 510(k) submission primarily refer to bench (mechanical) testing designed to ensure the device meets established standards for strength, fatigue, and other relevant mechanical properties to function safely within the human body. These tests are usually conducted in vitro.
- Mechanical Testing: This would typically involve tests like:
- Static Compression/Bending/Torsion: To assess the immediate strength and rigidity of the components.
- Dynamic (Fatigue) Testing: To simulate repetitive loading over time, ensuring the device can withstand physiological stresses without failure (e.g., millions of cycles at specific load levels).
- Pull-out strength: For screws into artificial bone.
- Insertion/Removal torque: For screws.
- Corrosion resistance.
- Material characterization.
Missing Information (Summary):
| Information Category | Status in Provided Text |
|---|---|
| 1. Table of Acceptance Criteria and Reported Device Performance | Not provided. The document states "Mechanical testing was presented" but gives no specific criteria (e.g., minimum load to failure, number of fatigue cycles without fracture) or the quantitative results of these tests. |
| 2. Sample Size (Test Set) and Data Provenance | Not applicable for clinical studies. For mechanical testing, the "sample size" would refer to the number of devices or components tested. This detail is not provided. Data provenance would be the lab where tests were conducted. |
| 3. Number of Experts and Qualifications (Ground Truth for Test Set) | Not applicable for clinical studies. For mechanical testing, "ground truth" is typically established by engineering standards (e.g., ASTM, ISO) and laboratory measurements. No human "experts" in the clinical sense are establishing ground truth for mechanical performance. |
| 4. Adjudication Method (Test Set) | Not applicable. |
| 5. MRMC Comparative Effectiveness Study and Effect Size (Human + AI vs. Human only) | Not applicable. This device is a physical implant, not an AI-assisted diagnostic or treatment planning tool. No human-in-the-loop AI component is mentioned. |
| 6. Standalone Algorithm Performance (without human-in-the-loop) | Not applicable. The device is a physical implant, not an algorithm. |
| 7. Type of Ground Truth Used | Not applicable for clinical studies. For mechanical testing, the "ground truth" would be the objective measurements obtained from laboratory equipment conforming to established engineering standards. |
| 8. Sample Size for Training Set | Not applicable. As "Summary of Clinical Tests (Not Applicable)" explicitly states, no clinical studies were performed. This device is not an AI/ML algorithm that would require a "training set" of data in the common sense. For mechanical testing, there isn't really a "training set"; instead, tests are conducted according to standardized protocols. |
| 9. How Ground Truth for Training Set Was Established | Not applicable. For mechanical testing, the "ground truth" (i.e., whether the device passed or failed a specific test) is established by directly measuring its performance against pre-defined engineering acceptance criteria, typically outlined in relevant ASTM or ISO standards, and comparing it to the performance of the predicate device (or exceeding it) to support substantial equivalence. This is not a "training set" in the AI/ML context. |
§ 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.