(98 days)
The 4CIS® VANE Spine System is indicated for temporary or permanent correction or stabilization of the vertebral column from the thoracic to the sacrum and with the aim of helping consolidation or bone fusion, The 4CIS® VANE Spine System is designed for both posterior and anterior fixation procedure.
The 4CIS® VANE Spine System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the 4CIS® VANE Spine System is intended to provide immobilization 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 Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
The 4CIS® VANE Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) linking mechanism.
The 4CIS® VANE Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. 4CIS® VANE Spine System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the 4CIS® VANE Spine System
Here's an analysis of the provided text regarding the acceptance criteria and study for the 4CIS® VANE Spine System:
Based on the provided document, the device's acceptance criteria and the study that proves it meets those criteria are primarily focused on mechanical testing for substantial equivalence to predicate devices.
Here's the breakdown of the information requested:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical equivalence to predicate devices as per ASTM F1717. | "Mechanical testing as listed in APPENDIX 10 that was conducted in accordance with ASTM F1717 demonstrates equivalence to the above predicate devices." |
Note: The document does not specify quantifiable acceptance criteria (e.g., minimum torque, fatigue life cycles, etc.) or specific performance metrics from the study. It only states that the testing demonstrated "equivalence." A complete submission would typically include the specific values tested against and the results obtained.
Study Details
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated. For mechanical testing, this would typically involve a specific number of devices tested for each parameter (e.g., 6 samples per test as per common ASTM standards).
- Data Provenance: Not explicitly stated. Mechanical testing is performed in a laboratory setting, not typically on patient data.
- Retrospective or Prospective: Not applicable, as this is laboratory mechanical testing, not a clinical study.
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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. This device undergoes mechanical testing against engineering standards (ASTM F1717), not clinical evaluation requiring expert interpretation of patient data.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is mechanical testing that measures physical properties against established standards, not a subjective assessment requiring adjudication.
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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:
- No. This is a spinal fixation system, a physical implant. MRMC studies are relevant for AI-powered diagnostic devices, not for mechanical implants.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (implant), not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this study is the performance requirements established by the ASTM F1717 standard for spinal implant constructs, and the performance of the legally marketed predicate devices (Global Spinal Fixation System (K001668) and OPTIMATY, Spinal System (K031585)). The device must perform equivalently to these established standards and predicate devices in mechanical tests.
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The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set is involved.
Summary of available information:
The provided 510(k) summary focuses on the mechanical performance of the 4CIS® VANE Spine System. The primary study mentioned indicates that mechanical testing was conducted in accordance with ASTM F1717, and these tests "demonstrate equivalence to the above predicate devices." This is a common approach for demonstrating substantial equivalence for physical implants where the function and materials are similar to already approved devices. The document does not provide specific numerical results, detailed methodologies, or quantitative acceptance criteria beyond the general statement of "equivalence" to the predicate devices and compliance with the ASTM standard.
§ 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.