(217 days)
The TiLock Pedicle Screw 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 thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Genesys Spine TiLock Pedicle Screw System is comprised of polyaxial screws (standard and cannulated) and monoaxial screws in various lengths and diameters, lock plugs, cross-links, tulips and rods in various lengths. The Til.ock System allows the placement of either 5.5mm titanium or 5.5mm cobalt chromium rods. The TiLock cannulated polyaxial screws may be implanted via a minimally invasive technique. Manual instrumentation for implantation of the svstem is available for both conventional and minimally invasive procedures. The minimally invasive procedure is performed using k-wire and fluoroscopy, which allows the implanting surgeon to employ two smaller incisions rather than a longer midline incision.
The subject device is the result of modifications to the existing Genesys Spine TiLock rod system which resulted in the inclusion of a 5.5mm straight and prebent cobalt chromium rod to the system. The subject device shares the same intended use and fundamental scientific technology as the predicate device.
The Genesys Spine TiLock Pedicle Screw System is a medical device. Here's a breakdown of the information regarding its acceptance criteria and supporting studies:
1. Acceptance Criteria and Reported Device Performance
The provided document describes the device's substantial equivalence to predicate devices, rather than establishing specific quantitative performance acceptance criteria for diagnostic output. The primary "acceptance criteria" here is demonstrated substantial equivalence in terms of mechanical and material properties, meaning the modified device performs similarly to or better than previously approved devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical properties (e.g., strength, durability, fatigue resistance) | Test results demonstrate that the TiLock System is substantially equivalent to the predicate device. Finite element and material property analysis as well as design verification results demonstrate that the proposed device is substantially equivalent to the predicate device. |
| Material composition for biocompatibility and performance | "material property analysis" demonstrating substantial equivalence to predicate device. Inclusion of a 5.5mm straight and prebent cobalt chromium rod, implying material properties are comparable or superior to predicate's rod materials. |
| Intended Use | Shares the same intended use as the predicate device. |
| Fundamental Scientific Technology | Shares the same fundamental scientific technology as the predicate device. |
2. Sample Size and Data Provenance for Test Set
- Test Set Sample Size: Not explicitly stated as a distinct "test set" in the context of typical AI algorithm evaluation. The evaluation is based on design verification results, finite element analysis, and material property analysis. These generally do not involve a "sample size" of patient data or images in the same way. Instead, they refer to the number of simulations, physical tests, or material samples analyzed. The document does not specify these numbers.
- Data Provenance: Not applicable in the context of this type of device submission. The evaluation is non-clinical, focusing on engineering and material properties, not patient data.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts: Not applicable. Ground truth, in this context, refers to established engineering standards, material science principles, and mechanical testing protocols.
- Qualifications of Experts: Not explicitly stated. However, it's inferred that the "design verification results" and "finite element and material property analysis" were conducted by qualified engineers and material scientists.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable. The evaluation relies on objective engineering and material testing, not subjective human assessment needing adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This device is a pedicle screw system, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done: No. This device is a physical medical implant, not an algorithm.
7. Type of Ground Truth Used
- Ground Truth Type:
- Engineering Standards and Specifications: Mechanical strength, fatigue limits, material compatibility, and overall design integrity according to established biomechanical and medical device standards.
- Predicate Device Performance: The primary ground truth is the performance characteristics of the legally marketed predicate devices, to which the new device is compared for substantial equivalence.
8. Sample Size for Training Set
- Training Set Sample Size: Not applicable. This device is not an AI algorithm that requires a "training set" of data.
9. How Ground Truth for Training Set was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study that proves the Genesys Spine TiLock Pedicle Screw System meets its (implied) acceptance criteria is a non-clinical engineering and material science evaluation. This evaluation aimed to demonstrate substantial equivalence to existing predicate devices.
The key components of this study were:
- Finite Element Analysis (FEA): This is a computational method used to predict how a product reacts to real-world forces, heat, vibration, fluid flow, and other physical effects. It simulates the mechanical behavior of the pedicle screw system under various loads and conditions to ensure its structural integrity.
- Material Property Analysis: This involves characterizing the mechanical, chemical, and physical properties of the materials used in the device (e.g., titanium, cobalt chromium). This ensures the materials meet required standards for strength, biocompatibility, and durability.
- Design Verification Results: This encompasses a range of tests and analyses to confirm that the device design meets its intended specifications and functions as expected. This could include bench testing for mechanical performance, dimensional analysis, and other forms of verification.
Conclusion: The regulatory submission states that these non-clinical performance data (finite element, material property analysis, and design verification results) were sufficient to demonstrate that the Genesys Spine TiLock Pedicle Screw System is substantially equivalent to its predicate devices. This means that, based on these engineering and material science studies, the device is considered as safe and effective as other devices already legally marketed for the same intended use. No clinical studies were deemed necessary for this particular submission.
§ 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.