(87 days)
When intended to promote fusion of the occipitocervical spine, the cervical spine, and the thoracic spine, (Occiput-T3), the TRAVERSE™ OCT Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Occipitocervical Plate/Rod/Occipital Screws/Hooks: The occipitocervical plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine. The use of the occipitocervical plates and rods requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.
Hooks: The hooks are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Multi-Axial Screws/Connectors: The use of multi-axial screws is limited to placement of TI-T3. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS® Cable used with the TRAVERSE™ OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.
The TRAVERSE™ OCT Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the occipital, cervical and/or upper thoracic spine. The TRAVERSE™ OCT Spinal Fixation System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws, plates and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both systems for labeling limitations. The TRAVERSE™ OCT Spinal Fixation System is fabricated from medical grade titanium alloy. Never use titanium alloy with stainless steel in the same construct. The TRAVERSE™ OCT Spinal Fixation System also includes a retaining ring for the multi-axial screws made of Shape Memory Alloy (Nitinol-NiTi). Shape Memory Alloy is compatible with titanium alloy. The offset connectors and multi-axial screw saddle contain elastomeric stakes made of silicone adhesive, and the occipital plates contain nickel-cobalt-chromium-molybdenum alloy coil springs. These materials are commonly used in implantable medical devices. Do not use with stainless steel.
Here's an analysis of the provided text regarding the TRAVERSE™ OCT Spinal Fixation System, focusing on acceptance criteria and study details.
Based on the provided text, the TRAVERSE™ OCT Spinal Fixation System is a mechanical device, not a diagnostic AI system or image-based device. Therefore, the concepts of "acceptance criteria" and "study" as typically applied to AI/diagnostic devices (e.g., performance metrics like sensitivity/specificity, ground truth, expert adjudication, MRMC studies, standalone performance) do not directly apply in this context.
Instead, for such a device, "acceptance criteria" relate to mechanical and material performance standards, and the "study" demonstrating this involves mechanical testing to show substantial equivalence to predicate devices.
Here's how to interpret the request in the context of this device:
Acceptance Criteria and Study for TRAVERSE™ OCT Spinal Fixation System
Given that the TRAVERSE™ OCT Spinal Fixation System is a spinal fixation system, the "acceptance criteria" and "study" described in the 510(k) summary are related to its mechanical performance and material compatibility, rather than diagnostic accuracy. The study aims to demonstrate substantial equivalence to existing, legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category/Metric | Reported Device Performance |
|---|---|
| Premarket Requirement | Substantial Equivalence to legally marketed devices. |
| Mechanical Performance | Equivalent to or better than the testing performed for the VERTEX® Reconstruction System's occipital components. |
| Material Compatibility | Fabricated from medical grade titanium alloy. Retaining ring made of Shape Memory Alloy (Nitinol-NiTi), compatible with titanium alloy. Offset connectors and multi-axial screw saddle contain elastomeric stakes made of silicone adhesive. Occipital plates contain nickel-cobalt-chromium-molybdenum alloy coil springs. Material compatibility (titanium alloy with stainless steel, etc.) implicitly meets internal standards. |
| Biocompatibility | Materials commonly used in implantable medical devices. |
| Indications for Use (Safety & Efficacy) | Demonstrated by substantial equivalence to predicate device with established clinical use for indicated conditions (DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors). |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set: Not applicable in the traditional sense for a mechanical device. The "test set" here refers to the actual TRAVERSE™ OCT Spinal Fixation System components and the predicate devices (VERTEX® Reconstruction System components) used for comparative mechanical testing. The specific number of components or samples tested is not specified in the provided summary.
- Data Provenance: The mechanical testing data would be generated in a lab setting, likely by the manufacturer (Medtronic Sofamor Danek USA). There is no mention of country of origin for patient data as this is not a clinical study. It's a retrospective comparison to an existing predicate device's performance data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. For a mechanical device, "ground truth" is established through engineering specifications, material standards, and validated mechanical testing protocols, not by expert medical consensus on images or clinical outcomes. The "experts" would be materials scientists and mechanical engineers.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of diagnostic data. For mechanical testing, results are typically quantitative and compared against predefined performance thresholds or predicate device data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not done. MRMC studies are used to evaluate the impact of a diagnostic tool on human reader performance. This device is a surgical implant, not a diagnostic tool that involves human interpretation of cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This concept pertains to the performance of an AI algorithm in isolation. The TRAVERSE™ OCT Spinal Fixation System is a physical implant, not an algorithm.
7. The Type of Ground Truth Used:
- For this mechanical device, the "ground truth" is based on:
- Validated Mechanical Testing Standards: Industry-accepted standards for spinal implant performance (e.g., fatigue, static strength, push-out, pull-out tests).
- Predicate Device Performance Data: Established performance characteristics of the legally marketed VERTEX® Reconstruction System.
- Material Specifications: Compliance with medical-grade material standards (e.g., titanium alloy properties).
8. The Sample Size for the Training Set:
- Not applicable. This device does not involve machine learning or an "algorithm" with a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no training set for an algorithm, there is no ground truth establishment for it.
Summary of the Study (Mechanical Substantial Equivalence Study):
The core "study" described in the 510(k) summary is a mechanical testing comparative study.
- Objective: To demonstrate that the TRAVERSE™ OCT Spinal Fixation System is substantially equivalent to other commercially available posterior occipitocervical fixation systems and pre-enactment devices, specifically citing the VERTEX® Reconstruction System (K052402, K052734) as a predicate.
- Methodology: "Mechanical testing was provided." This typically involves laboratory tests conducted on the device components (rods, hooks, screws, plates, connectors) to evaluate their mechanical properties under various simulated physiological loads (e.g., static strength, fatigue, pull-out resistance).
- Results: "The results of the testing performed for the TRAVERSE™ OCT Spinal Fixation System occipital components were equivalent to or better than the testing performed for the VERTEX® Reconstruction System occipital components." This statement directly addresses the acceptance criterion of substantial equivalence based on mechanical performance.
In essence, for this specific medical device, the "acceptance criteria" are met by demonstrating that its physical and mechanical properties are either the same as, or superior to, those of a legally marketed, predicate device, thereby ensuring it is as safe and effective for its intended use.
§ 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.