(167 days)
The Mega Plus 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 disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
The Mega Plus Spine System is a top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws (multi-axial, multi-axial long-arm, mono and long-arm), iliac screws, rods, locking bolts, cross-links and connectors. The Mega Plus Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Mega Plus 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 Plus Spine System.
This document is a 510(k) summary for the "Mega Plus Spine System," a medical device intended for spinal fusion. The FDA has determined it is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the provided information, focusing on the absence of information rather than its presence, as this is a mechanical device, not an AI/software device.
1. Table of acceptance criteria and the reported device performance
The document lists performance tests conducted for the Mega Plus Spine System, all based on ASTM standards. However, it does not explicitly state specific quantitative acceptance criteria or detailed numerical results for these tests. It only makes a general concluding statement about the sufficiency of the device's strength.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (e.g., minimum load, cycles) | Static compression bending per ASTM F1717-15: "results...show that the strength of the Mega Plus Spine System is sufficient for its intended use" |
| Not explicitly stated (e.g., minimum load, cycles) | Static tension bending per ASTM F1717-15: "results...show that the strength of the Mega Plus Spine System is sufficient for its intended use" |
| Not explicitly stated (e.g., minimum torque, cycles) | Static torsion per ASTM F1717-15: "results...show that the strength of the Mega Plus Spine System is sufficient for its intended use" |
| Not explicitly stated (e.g., minimum load, cycles) | Dynamic axial compression bending fatigue per ASTM F1717-15: "results...show that the strength of the Mega Plus Spine System is sufficient for its intended use" |
| Not explicitly stated (e.g., specific component failure thresholds) | Component testing per ASTM F1798-13: "results...show that the strength of the Mega Plus Spine System is sufficient for its intended use" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample size for any of the performance tests.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. It only mentions that BK MEDITECH Co., Ltd. is based in the Republic of Korea.
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 question is not applicable to this document. The Mega Plus Spine System is a mechanical spinal implant, not a diagnostic or AI device that requires expert-established ground truth from medical imaging or clinical assessment for its performance evaluation (beyond internal engineering validation). The "ground truth" for this type of device is its mechanical integrity and compliance with engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as there is no mention of human observation or assessment of the performance data that would require an adjudication method. The performance data seems to be derived from objective mechanical testing.
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. The Mega Plus Spine System is a mechanical implant, not an AI-assisted diagnostic tool or an imaging device. Therefore, MRMC comparative effectiveness studies involving human readers and AI assistance are irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The Mega Plus Spine System is a mechanical implant; there is no algorithm or software component that operates in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by conformance to recognized engineering and material standards (ASTM F1717-15 and ASTM F1798-13) and the mechanical properties of its constituent materials (titanium alloy Ti-6Al-4V ELI). These standards implicitly define what constitutes acceptable mechanical performance for spinal fixation devices.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of mechanical device testing for a spinal implant. Training sets are relevant for machine learning algorithms or AI models.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 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.