(132 days)
The VENUS BASIC Spinal Fixation 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 VENUS BASIC Spinal Fixation System is 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 Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
The VENUS BASIC Spinal Fixation 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 VENUS BASIC Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. VENUS BASIC Spinal Fixation System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the VENUS BASIC Spinal Fixation System
Here's a breakdown of the acceptance criteria and study information for the VENUS BASIC Spinal Fixation System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Static Test (ASTM F1717-04) | Equivalence to predicate devices | Demonstrated equivalence to predicate devices. |
| Mechanical Performance | Dynamic (Fatigue) Test (ASTM F1717-04) | Equivalence to predicate devices | Demonstrated equivalence to predicate devices. |
Note: The provided document primarily focuses on demonstrating substantive equivalence through mechanical testing, rather than setting specific numerical performance thresholds for the device itself. The acceptance criteria are implicitly met by demonstrating that its mechanical properties are comparable to legally marketed predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data or human evaluations. The performance data presented refers to mechanical testing.
- Sample Size for Mechanical Testing: Not explicitly stated in terms of number of devices or components. It's generally understood that mechanical tests adhering to ASTM standards involve a sufficient number of samples to ensure statistically sound results, but the exact count is not provided.
- Data Provenance: The mechanical testing was conducted in accordance with ASTM F1717-04. This is a recognized international standard for spinal implant testing. The tests would likely have been performed in a laboratory setting, presumably by or for the manufacturer (Implanova Co.,Ltd. / L&K BIOMED Co., Ltd. in Republic of Korea). The data is generated prospectively for the purpose of regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this 510(k) submission. The "ground truth" here is established through physical mechanical testing according to an engineering standard (ASTM F1717-04), not through expert clinical interpretation or consensus.
4. Adjudication Method for the Test Set
This information is not applicable as the "test set" refers to mechanical testing, not a clinical study involving human readers/evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (spinal fixation system) and relies on mechanical testing to demonstrate substantial equivalence, not clinical effectiveness studies with human readers interpreting results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical pedicle screw spinal fixation system, not an algorithm or AI software. Therefore, there is no "standalone performance" of an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating the device's performance is based on objective measurements derived from mechanical testing protocols (ASTM F1717-04). This standard sets forth the methods for evaluating static and fatigue properties of spinal implant constructs, and the reported equivalence to predicate devices serves as the truth for regulatory purposes.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this device, as it is a physical implant and not an AI/ML model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
§ 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.