(56 days)
The Mega 5.5 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 autogeneous bone graft, having implants attached to the lumbar and sacral spine (1.3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the Mega 5.5 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 (pseudoarthrosis).
The MEGA5.5 Spine System is a top-loading multiple component, posterior spinal fixation systems which consists of pedicle screws (mono, long-arm, multi-axial long-arm screw), rods, locking bolt, and a transverse linking mechanism (cross-link). The M EGA5.5 Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The MEGA5.5 Spine System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-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 5.5 Spine System.
The provided text describes a 510(k) premarket notification for the "MEGA 5.5 Spine System," which is a pedicle screw spinal fixation system. The study described is mechanical testing to demonstrate the substantial equivalence of the device to legally marketed predicate devices.
Here's an analysis of the provided information relative to your requested categories:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in a table format. Instead, it states that the mechanical testing "demonstrates equivalence to the above predicate devices." This implies that the performance of the MEGA 5.5 Spine System met or exceeded the performance of the predicate devices under the specified ASTM standard.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to predicate devices based on ASTM F 1717 standards. | Demonstrated equivalence through static and dynamic comprehension bending, static tension bending, and static torsion. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size (e.g., number of screws, rods tested) for the mechanical testing. It also does not provide details on data provenance like country of origin or whether the data was retrospective or prospective, as mechanical testing is typically performed in a lab setting rather than with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This category is not applicable. For mechanical testing of a spinal implant, "ground truth" as it relates to clinical or imaging expert assessment is not established. The ground truth is determined by the physical properties and performance metrics measured according to the ASTM standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This category is not applicable to mechanical testing. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or assessment, not for direct physical testing of device components.
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
No, an MRMC comparative effectiveness study was not done. This device is a physical spinal implant, not an AI software B medical device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone (algorithm only) performance study was not done. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this study is defined by the objective measurements and engineering standards outlined in ASTM F 1717 for spinal implant mechanical testing. It relies on physical measurements and compliance with established engineering specifications rather than expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This category is not applicable. Mechanical testing of a physical implant does not involve a "training set" in the context of machine learning or AI models. There is no algorithm being trained.
9. How the ground truth for the training set was established
This category is not applicable for the same reason as above; there is no training set for mechanical testing.
§ 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.