(28 days)
The MANTIS® Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disc disease (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.
This Special 510(k) submission is intended to introduce a line extension to the MANTIS Spinal System, which entails additional diameter size cannulated polyaxial screw components as well as additional straight rod components in a variety of lengths. Modifications were made to the existing MANTIS Spinal System (K061813) to render the new components. The MANTIS Spinal System will include cannulated polyaxial screw, pre-bent rod and straight rod components that can be used via either a percutaneous surgical approach or a standard open approach.
The provided text does not describe the acceptance criteria or a study that proves a device meets such criteria. Instead, it is a 510(k) summary for a spinal fixation system, focusing on its substantial equivalence to predicate devices and its intended use.
Therefore, I cannot provide the requested information in the format specified because the necessary details are not present in the given input.
The document discusses:
- Proprietary Name: MANTIS® Spinal System
- Common Name: Spinal Fixation Appliances
- Regulatory Class: Class III
- Device Product Code: 87 MNH, 87 MNI, 87 NKB
- Predicate Devices: Stryker Spine MANTIS Spinal System (K061813), Stryker Spine Xia® Titanium Spinal System (K013823, K043473, K002858, K060361), and Stryker Spine Osteonics Spinal System (K951725).
- Description of Device Modification: Line extension including additional diameter size cannulated polyaxial screw components and additional straight rod components.
- Intended Use: Posterior, non-cervical pedicle fixation for indications such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion.
- Technological Comparison: States that the additional screw and rod components have equivalent mechanical properties to the predicate devices and are made from the same materials.
Missing Information:
The document does not contain any information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method for a test set.
- Multi-reader, multi-case (MRMC) comparative effectiveness study or effect size.
- Standalone (algorithm only) performance study.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
This is a regulatory submission aimed at demonstrating substantial equivalence based on material and mechanical properties compared to already cleared devices, not a study evaluating performance against specific acceptance criteria for a new feature or algorithm.
§ 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.