(409 days)
The THUNDERBOLT™ Minimally Invasive and LANCER™ Open Pedicle Screw Systems are 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: degenerative disc disease (DDD: defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used in a posterior percutaneous approach with MIS instrumentation, the THUNDERBOLT™ System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; deformities; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion.
The THUNDERBOLT™ and LANCER™ Pedicle Screw System is an implant device made from titanium alloy TI 6Al 4V-ELI. It is to be implanted from the posterior approach. The screws are available in diameters from 4.5-9.5mm and in lengths from 25-110mm. Rods are available in 5.5mm diameter in lengths from 30-440mm and in an array of configurations including, straight and pre-lordosed configurations. Rods are available in both titanium alloy Ti 6Al 4V-ELI and Cobalt Chrome alloy Co-28Cr-6Mo. The system includes set screws, pedicle screws, cross connectors and rods along with the associated instrumentation to complete the procedure and implant construct.
The provided document is a 510(k) summary for a medical device (THUNDERBOLT™ and LANCER™ Pedicle Screw Systems) and is primarily focused on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting detailed performance studies against specific criteria.
Therefore, most of the information requested cannot be extracted from this document, as it does not contain the level of detail regarding clinical trials, acceptance criteria, ground truth establishment, or human reader studies.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not explicitly stated as pass/fail criteria from a clinical trial in this document. The "Performance Standards" section refers to ASTM standards for mechanical testing, which implies the device must meet the requirements of these standards.
- Reported Device Performance: The document states: "The tests included static axial compression bending, static torsion and dynamic axial compression bending. The test results are substantially equivalent to those of the predicate devices." No specific numerical performance metrics are provided.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet ASTM F1717 standards (static axial compression bending, static torsion, dynamic axial compression bending) | Test results are "substantially equivalent" to predicate devices. |
| Meet ASTM F1798 standards | Test results are "substantially equivalent" to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document. This document details in-vitro mechanical testing, not clinical data with human subjects or a test set of patient data.
- Data Provenance: The document only mentions that "Performance testing was completed by an independent laboratory." No details on geographic origin or retrospective/prospective nature are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document describes a 510(k) submission for a physical medical implant (pedicle screw system), which relies on mechanical performance testing rather than expert-derived ground truth for image analysis or diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human readers or a diagnostic algorithm that would require adjudication.
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 document is for a medical implant, not an AI/diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For mechanical testing, the "ground truth" would be the physical properties and performance characteristics as measured by the specified ASTM standards. These are objective measures rather than expert consensus or pathology.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, and the document focuses on mechanical testing, not a machine learning model with a training set.
9. How the ground truth for the training set was established:
- Not applicable. Similar to point 8, there is no training set mentioned or implied in the context of this device and testing.
§ 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.