(18 days)
The Vital® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.
These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vital Spinal Fixation System is intended to be used with autograft and/or allograft.
In addition, the Vital Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vital System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vital System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The use of the Vital® Spinal Fixation System in skeletally mature patients may include the fixation of the Instinct® Java™ Spinal Fixation System hooks, APEX Spinal System™ hooks, or fixation of the Universal Clamp® Spinal Fixation System to the Vital® Spinal Fixation System. The Vital® Spinal Fixation System may also be used in skeletally immature patients when connected with the Universal Clamp Spinal Fixation System.
To achieve additional levels of fixation in skeletally mature patients, the Vital® Spinal Fixation System may be connected to the Virage® OCT Spinal Fixation System and the Instinct Java Spinal Fixation System offered by Zimmer Biomet Spine, using rod connectors.
The Vital® Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, hooks and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient's anatomy. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred.
The system also includes instrumentation for insertion, securing and removal of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical grade cobalt chromium allov. Implants made from medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct.
Vital® MIS System is a percutaneous screw delivery system that is an extension of the Vital® System. The predicate Vital implants consist of a variety of spinals rods and pedicle screws that are modified under the MIS line extension to feature cannulated screws (extended and nonextended tab) and modified spinal rods (bullet nose, connection, curvature). The system includes a variety of instrumentation which are also compatible with Vital and Vital MIS implant offerings in the Vital® System and allow for a minimalized, percutaneous, or mini-open surgical approach, extending MIS capabilities to the cannulated implants of the wider Vital System.
This is a 510(k) summary for the Vital Spinal Fixation System, which is a spinal implant system, not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, experts, and comparative effectiveness studies that are typically associated with AI/ML device evaluations is not present in this document.
The document discusses the substantial equivalence of the new Vital® Spinal Fixation System to a predicate device (Vital® System K230116). The assessment focuses on mechanical and material aspects, not algorithmic performance.
Here's a breakdown of the specific information that can and cannot be provided from the given text:
1. A table of acceptance criteria and the reported device performance
- This document does not specify quantitative acceptance criteria or detailed performance metrics in the way an AI/ML device submission would. Instead, it states that the "Vital® System's indications for use, intended use, design, materials, and performance assessments are substantially equivalent to the currently marketed Vital® System and do not impact the safety and effectiveness of the system." This suggests that the acceptance criteria are met by demonstrating equivalence to the predicate device, likely through bench testing (mechanical and material properties) which are not detailed here.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as this is not an AI/ML device. There is no mention of a "test set" in the context of data for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this is not an AI/ML device. "Ground truth" in this context would relate to the physical properties and performance of the device, established through engineering and biomechanical testing, rather than expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not an AI/ML device.
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 as this is not an AI/ML device. No human-in-the-loop AI assistance is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For a spinal fixation system, "ground truth" for demonstrating safety and effectiveness would typically be established through biomechanical testing, material characterization, and potentially animal or cadaveric studies to ensure the device meets specified engineering standards for strength, fatigue, corrosion, and biocompatibility. The document infers these types of assessments were done to show "substantial equivalence" to the predicate, but does not detail them.
8. The sample size for the training set
- Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI/ML device.
§ 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.