(56 days)
VENUS Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use:
- 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, kyphosis, and/or lordosis); .
- tumor;
- stenosis, and
- failed previous fusion (pseudoarthrosis)
The VENUS 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 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, spinal tumor and failed previous fusion (pseudoarthrosis).
This system is comprised of screws, set screws, rods, crosslink and connectors. The components of this system are manufactured of Titanium alloy (Titanium-6Aluminum-4 Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 8.5mm diameters with lengths ranging from 20-150mm.
This document describes the design and testing of the VENUS Spinal Fixation System, a non-cervical spinal fixation device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Static Compression Bending (ASTM F1717-10) | Performance must be equivalent to predicate devices. | The VENUS Spinal Fixation system performs equivalently to the predicates in static compression bending. |
| Static Torsion (ASTM F1717-10) | Performance must be equivalent to predicate devices. | The VENUS Spinal Fixation system performs equivalently to the predicates in static torsion. |
| Dynamic Compression Bending (ASTM F1717-10) | Performance must be equivalent to predicate devices. | The VENUS Spinal Fixation system performs equivalently to the predicates in dynamic compression bending. |
| Gripping-Push Down (ASTM F1798) | Performance must be equivalent to predicate devices. | The VENUS Spinal Fixation system performs equivalently to the predicates in gripping-push down. |
Note: The document explicitly states that the acceptance criterion for all performance tests is "equivalent to the predicates." The specific numerical or qualitative thresholds for this equivalence are not provided in this summary but would be detailed in the full test reports.
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not explicitly stated for each test. The document refers to "bench testing results," implying that multiple samples of the VENUS Spinal Fixation System components were subjected to each test.
- Data Provenance: The tests are "bench testing" conducted by L&K BIOMED, Co., Ltd. The country of origin for the testing would be South Korea, where L&K BIOMED is located. The data is prospective, generated specifically for this 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth of Test Set
This section is not applicable as the provided documentation describes a medical device (spinal fixation system) and its mechanical performance testing, not an AI/diagnostic device that would require expert-established ground truth for a test set. The "ground truth" here is the physical measurement of mechanical properties.
4. Adjudication Method for Test Set
This section is not applicable for the same reasons as point 3. Mechanical test results do not typically involve adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This section is not applicable as the provided documentation describes a medical device (spinal fixation system) and its mechanical performance testing, not an AI or diagnostic device that would involve human readers or MRMC studies.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
This section is not applicable as the provided documentation describes a medical device (spinal fixation system) and its mechanical performance testing, not an AI or algorithm-based device.
7. Type of Ground Truth Used
The ground truth used for performance evaluation is based on standardized mechanical testing results (e.g., measurements of strength, stiffness, and fatigue performance) as per established ASTM standards (F1717-10 and F1798). The "ground truth" performance is then compared to that of legally marketed predicate devices.
8. Sample Size for the Training Set
This section is not applicable as the provided documentation describes a medical device (spinal fixation system) and its mechanical performance testing, not a machine learning or AI device that would have a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 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.