(106 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 only allows the placement of 5.5 mm titanium rods. The TiLock cannulated polyaxial screws may be implanted via a minimally invasive technique. Manual instrumentation for implantation of the system 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 provided document describes the Genesys Spine TiLock Pedicle Screw System and its 510(k) submission for substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the context of device performance as one might expect for a diagnostic or AI-driven medical device.
Instead, the "acceptance criteria" for this type of medical device (a pedicle screw system) are typically met through demonstrating substantial equivalence to legally marketed predicate devices, primarily through mechanical testing. The document states that "Mechanical test results demonstrate that the minor differences do not impact device performance as compared to the predicate."
Here's a breakdown of the requested information based on the provided text, noting where specific details are not applicable or not present for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static axial compression bending testing in accordance with ASTM F1717-04 | "The following non-clinical tests were conducted, the results of which demonstrate that the Genesys Spine Tillock Pedicle Screw System is substantially equivalent to the predicate(s): - Static and dynamic axial compression bending testing, conducted in accordance with ASTM F1717-04" |
| Dynamic axial compression bending testing in accordance with ASTM F1717-04 | "The following non-clinical tests were conducted, the results of which demonstrate that the Genesys Spine Tillock Pedicle Screw System is substantially equivalent to the predicate(s): - Static and dynamic axial compression bending testing, conducted in accordance with ASTM F1717-04" |
| Static torsion testing in accordance with ASTM F1717-04 | "The following non-clinical tests were conducted, the results of which demonstrate that the Genesys Spine Tillock Pedicle Screw System is substantially equivalent to the predicate(s): - Static torsion testing, conducted in accordance with ASTM F1717-04" |
| Substantial Equivalence to Predicate Devices (Interpore Cross Synergy Polyaxial (K984578), DePuy Spine Expedium (K081252, K041801), DePuy Spine Moss Miami (K955348), DePuv Spine VSP Spine System (K984350), US Surgical Rogozinski Spinal Rod System (K983904)) | "The Genesys Spine TiLock System was determined to be substantially equivalent to the following predicate systems... The subject and predicate device share the same intended use and material of manufacture. The subject and predicate device have similar technological characteristics and the minor differences do not raise any new issues of safety and effectiveness." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of human data. For mechanical testing, the "sample size" refers to the number of test articles (pedicle screws) subjected to the tests. This specific number is not provided in the document.
- Data Provenance: The data provenance is from non-clinical mechanical testing, performed in a lab setting, not from human clinical studies or retrospective/prospective data collection from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is cleared based on mechanical performance tests against established ASTM standards and comparison to predicate devices, not on diagnostic accuracy requiring expert ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication process is described for this type of device submission.
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 medical implant (pedicle screw system), not an AI-driven diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth for Mechanical Performance: The "ground truth" or reference for mechanical performance is established by the specifications and pass/fail criteria defined within the ASTM F1717-04 standard for spinal implant constructs, and by comparison to the performance of the predicate devices. Mechanical properties like stiffness, fatigue strength, and torsional resistance are measured against these standards and previous devices.
8. The sample size for the training set
- Not applicable. This device does not involve machine learning or a training set.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve machine learning or a training set.
§ 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.