(108 days)
The VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The VADER® one Pedicle System MIS is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The LightMore® Pedicle System 6.0 is indicated to provide the surgeon with an open approach for posterior spinal surgery.
The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are posterior pedicle systems manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight and J-rods. The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 can be used for single or multiple level fixations in the non-cervical spine.
This document is a 510(k) summary for the VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0, which are spinal implant devices. It describes the device, its indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. However, it does not contain the information required to answer the specific questions about acceptance criteria and a study that proves the device meets those criteria, especially in the context of an AI/ML device.
The provided text focuses on the regulatory clearance process for a medical device (pedicle screw system), which primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices through material, design, function, and performance testing (e.g., mechanical tests like ASTM F543, F1717, F1798, and biocompatibility).
Here's why the requested information cannot be extracted from this document:
- No mention of AI/ML: The document describes a physical medical device (pedicle screw system) and its mechanical and biocompatibility testing. There is no indication that this device is an AI/ML diagnostic or therapeutic tool with performance metrics like sensitivity, specificity, or accuracy.
- Performance testing is for mechanical equivalence, not diagnostic accuracy: The "Performance Testing Summary" lists standards like ASTM F543 (screw testing) and ASTM F1717 (pedicle screw system testing). These are industry standards for evaluating the mechanical properties and structural integrity of spinal implants. They are not metrics for evaluating the performance of a diagnostic or predictive algorithm.
- "Clinical Data" is mentioned but not detailed: While "Clinical Data" is listed as one of the performance tests, no details are provided about what this data entails, how it was collected, what endpoints were measured, or if it relates to a study proving performance against acceptance criteria for an AI/ML system. In the context of a pedicle screw system, clinical data would typically refer to observational studies or clinical trials assessing patient outcomes, fusion rates, complication rates, etc., which are different from a study proving algorithm performance.
- No acceptance criteria for AI/ML performance: Given the nature of the device, there are no acceptance criteria defined for metrics such as sensitivity, specificity, AUC, or accuracy, which would be relevant for an AI/ML device's performance.
Therefore, since the device described is a physical medical implant and not an AI/ML-driven diagnostic/therapeutic tool, the questions about acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, and standalone performance for an AI/ML device are not applicable to this document.
§ 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.