(151 days)
The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/iium), posterior hook fixation (TI-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. scolosis, Scheuermann's Disease), tumor, stenoss, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality Spinal Fixation System is intended to be used with autograft and/or allograft.
In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusionenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fission. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.
When used for posterior non-cervical pediatic patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality® System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The use of the Vitality Spinal Fixation System in skeletally mature patients may include the fixation of the Instinct® JavaTM Spinal Fixation System hooks, Apex Spinal System hooks, or fixation of the Universal Clamp® Spinal Fixation System to the rods of the Vitality Spinal Fixation System. The Vitality Spinal Fixation System may also be used in skeletally immature patients when connected with the Universal Clamp® Spinal Fixation System.
In order to achieve additional levels of fixation in skeletally mature patients, the Vitality Spinal Fixation System may be comected to the Virage® OCT Spinal Fixation System and the Instinct® JavaTM Spinal Fixation System offered by Zimmer Spine, using rod connectors.
The Vitality 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, 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 alloy.
The provided text is a 510(k) summary for the Vitality® Spinal Fixation System. It focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a specific study proving the device meets acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, the "acceptance criteria" discussed here refer to a set of non-clinical, mechanical performance standards.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Mechanical Performance Standards) | Reported Device Performance |
|---|---|
| Bench Testing per ASTM F1717 (Static Torsion) | "assessed and tested appropriately to design controls" |
| Bench Testing per ASTM F1717 (Static and Dynamic Compression Bending) | "assessed and tested appropriately to design controls" |
| Bench Testing per ASTM F1798 (Axial grip strength) | "assessed and tested appropriately to design controls" |
| Bench Testing per ASTM F1798 (Torsional grip strength) | "assessed and tested appropriately to design controls" |
Note: The document states that the testing was conducted "appropriately to design controls; i.e. ASTM Standards," and that the device components "were assessed and tested appropriately to design controls." It does not provide specific numerical results or direct comparisons against pre-defined numerical acceptance criteria for each test. Instead, the conclusion is based on an overall assertion of substantial equivalence to predicate devices based on the type of testing performed and the "same mechanical and functional scientific technology."
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the traditional sense for a clinical study. The "test set" here refers to the physical Vitality® Spinal Fixation System implants that underwent mechanical bench testing. The specific number of implants tested per condition is not provided.
- Data Provenance: The tests are non-clinical bench tests, meaning they were conducted in a laboratory setting. There is no information on the country of origin of the data or whether it was retrospective or prospective, as these terms typically apply to clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For mechanical bench testing, "ground truth" is established by adherence to standardized ASTM testing protocols and engineering principles, not by expert medical consensus.
4. Adjudication method for the test set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies to resolve discrepancies in expert opinions for ground truth establishment. This is a non-clinical, mechanical testing scenario.
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 is a 510(k) submission for a spinal fixation system, not an AI/CADe device that involves human readers or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical spinal implant, not a software algorithm.
7. The type of ground truth used
For the mechanical performance, the "ground truth" is defined by the ASTM standards (ASTM F1717 for Static Torsion, Static and Dynamic Compression Bending, and ASTM F1798 for axial and torsional grip strength). The performance of the device components is compared against the expected performance based on these established engineering standards and, implicitly, against the performance of predicate devices that also comply with these standards.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable (see point 8).
Summary of the Study:
The "study" described in the 510(k) summary is a set of non-clinical bench tests designed to assess the mechanical integrity and performance of the Vitality® Spinal Fixation System implants. These tests were conducted according to established ASTM standards (F1717 and F1798).
The primary purpose of these mechanical performance tests was to demonstrate that the new device has "the same mechanical and functional scientific technology" and "substantially equivalent performance characteristics" to previously cleared predicate devices. The document concludes that the Vitality® Spinal Fixation System is substantially equivalent based on these non-clinical tests and shared technological characteristics, rather than reporting on clinical outcomes or diagnostic accuracy.
§ 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.