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510(k) Data Aggregation
(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.
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(53 days)
The REVERE® or BEACON™ Stabilization System, when used as a posterior 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 the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, pseudoarthrosis and failed previous fusion.
In addition, the REVERE® or BEACON™ Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used as a posterior non-pedicle screw fixation system, the REVERE® or BEACON™ Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.
When used as an anterolateral thoracolumbar system, the REVERE® or BEACON™ Stabilization System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
CoCr Rods consist of 5.5mm and 6.35mm rods manufactured from cobalt chromium molybdenum alloy. REVERE® and BEACON™ Stabilization System implants mate with these 5.5mm and 6.35mm diameter rods. The REVERE® and BEACON™ implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. CoCr Rods are composed of cobalt chromium-molybdenum alloy as specified in F1537.
Here's an analysis of the provided 510(k) summary for the CoCr Rods, focusing on acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance | Comments |
|---|---|---|---|
| Mechanical Performance | Compression-bending | Tested in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. | The document states testing was conducted in accordance with the guidance, implying the results met the criteria outlined in that guidance. Specific numerical results or pass/fail thresholds are not provided in this summary. |
| Mechanical Performance | Torsion | Tested in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. | Similar to compression-bending, this indicates compliance with the guidance, but specific quantitative results are absent. |
| Material | Biocompatibility | Composed of cobalt chromium-molybdenum alloy as specified in F1537. | This implies adherence to a recognized standard for surgical implant materials, which covers biocompatibility. No separate test results are presented. |
| Substantial Equivalence | Technical Characteristics | Similar to predicate devices. | The submission asserts similarity without specific details. |
| Substantial Equivalence | Material | Similar to predicate devices (CoCr-Mo alloy). | Directly mentioned in the device description. |
| Substantial Equivalence | Performance | Similar to predicate devices (based on mechanical testing). | Implied by the statement of "substantial equivalence" supported by mechanical testing. |
| Substantial Equivalence | Intended Use | Similar to predicate devices. | The stated indications for use are largely consistent with typical spinal stabilization systems. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document describes mechanical testing of the CoCr Rods. For such testing, the "sample size" refers to the number of physical rods and corresponding components subjected to the mechanical tests.
- Sample Size: The document does not explicitly state the number of rods or components used in the compression-bending and torsion tests.
- Data Provenance: The data provenance is pre-clinical mechanical testing, conducted by the manufacturer, Globus Medical Inc. There is no information suggesting external lab testing or geographical origin of the samples beyond the manufacturer's location in Audubon, PA. This is not clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to this submission. The "ground truth" in this context is established by engineering standards and physical measurements from mechanical stress tests, not by expert clinical consensus. There are no experts involved in establishing a "ground truth" for clinical outcomes in this 510(k) submission.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods are used in clinical studies or expert reviews to resolve discrepancies in observations or diagnoses. Mechanical testing results are objective measurements against predefined engineering standards.
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
This question is not applicable. This 510(k) submission is for a medical device (spinal rods) and not for an AI/CAD (Computer-Aided Detection) system. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable, as this is not an AI/CAD device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on established engineering standards and material specifications.
- For mechanical testing (compression-bending, torsion), the ground truth is defined by the failure criteria outlined in the referenced FDA Guidance document ("Guidance for Spinal System 510(k)s", May 3, 2004), as well as the inherent mechanical properties of the material.
- For material composition, the ground truth is adherence to ASTM F1537 (Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloys for Surgical Implants).
8. The sample size for the training set
This question is not applicable. There is no AI algorithm being trained, so there is no training set.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set.
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