(63 days)
The MEGA Spine 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 MEGA Spine 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, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
The MEGA Spine System is a top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, locking bolt, and a cross(transverse) linking mechanism.
The MEGA Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The MEGA Spine System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to the ASTM F136. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the MEGA Spine System.
The provided document is a 510(k) summary for the MEGA Spine System, a medical device for spinal fixation. It describes the device, its indications for use, and its substantial equivalence to predicate devices based on mechanical testing. However, it does not contain the specific information required to complete the table and answer the study-related questions as it is not a study report on device performance but a premarket notification for regulatory approval.
Based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Mechanical testing as listed in APPENDIX 9 that was conducted in accordance with ASTM F1717 demonstrates equivalence to the above listed predicate devices." However, it does not provide the specific acceptance criteria or the reported device performance metrics. Therefore, this table cannot be filled with the requested level of detail.
| Acceptance Criteria (e.g., Specific Mechanical Strength, Durability Thresholds) | Reported Device Performance (e.g., Achieved Mechanical Strength, Durability Cycles) | Met/Not Met (Based on Predicate Equivalence) |
|---|---|---|
| Not specified in the provided document. | Not specified in the provided document. | Stated as equivalent to predicate devices. |
Missing Information for Complete Answer:
The following information is not present in the provided 510(k) summary:
- Sample size used for the test set and the data provenance: This document does not detail specific sample sizes for mechanical testing or the origin of any data (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This document is about mechanical testing of a medical device, not a performance study involving human interpretation or ground truth establishment by experts.
- Adjudication method for the test set: Not applicable for mechanical testing.
- 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 device is not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical spinal implant, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for mechanical testing. The "ground truth" would be the ASTM standard and predicate device performance.
- The sample size for the training set: Not applicable to this type of device and study.
- How the ground truth for the training set was established: Not applicable to this type of device and study.
§ 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.