(26 days)
When intended for pedicle screw fixation from T1-S1, the InCompass Spinal Fixation 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 (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and failed previous fusion.
As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established.
When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity), degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.
When intended for anterolateral screw, rod and or cable fixation of the T6-L5 spine the indications are degenerative discase (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, deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor and failed previous fusion
After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.
The use of posterior spinal instrumentation in children has been reported in the literature. The InCompass Spinal Fixation System may be used for non-pedicle posterior use in this patient group.
The Spinal Concepts, Inc. InCompass Spinal Fixation System consists of various hooks, screws, rods and connectors and is intended to provide temporary stabilization following surgery to fuse the spine. This system includes open styled hooks and screws, which allow the surgeon to use a top loading technique for dropping the spinal rod down to the fixation components. Closed styled implants are also provided. Offset connectors are included to provide both offset between the screw and rod and also and reduce the effort needed to contour the spinal rod. Crosslinks are provided to increase rotational stiffness to longer constructs. Two sizes of spinal rods are included with this system. Screws are provided in both fixed angle and polyaxial design.
This 510(k) covers the addition of polyaxial screws in The InCompass system.
The provided document describes the "InCompass Spinal Fixation System, with Polyaxial Screws" and focuses on the mechanical testing performed to demonstrate its safety and effectiveness. However, it does not detail a study involving human readers, AI assistance, or an algorithm-only standalone performance evaluation. Instead, the study described is a mechanical test conducted on the device itself.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meet all functional requirements | Static and fatigue data provided |
| Conform to ASTM 1717 | Testing conducted in accordance with ASTM 1717 |
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for the mechanical tests. It only states that "static and fatigue data were provided." The data provenance is not mentioned beyond the fact that the tests were conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device is based on standardized mechanical testing (ASTM 1717) rather than expert human interpretation of medical data.
4. Adjudication method for the test set
Not applicable. The "adjudication method" usually refers to how disagreements are resolved among experts establishing ground truth in medical imaging studies. This document describes 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
No MRMC comparative effectiveness study was done. This document focuses on the mechanical properties of a spinal fixation system, not a diagnostic or AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical spinal fixation system, not an algorithm.
7. The type of ground truth used
The ground truth used was the performance standards outlined in ASTM 1717 for spinal instrumentation, specifically its static and fatigue properties.
8. The sample size for the training set
Not applicable. This is a physical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a mechanical device.
Summary of the Study:
The study conducted to prove the device meets acceptance criteria was a series of mechanical tests performed in accordance with ASTM 1717. These tests evaluated the static and fatigue properties of the InCompass Spinal Fixation System, including the newly added polyaxial screws. The intent was to demonstrate that the device met all functional requirements. The document does not provide specific quantitative results of these tests or the number of samples tested, but states that the data was provided to the FDA. The basis for substantial equivalence was that the modified system (with polyaxial screws) maintained the same fit, form, function, intended use, and fundamental scientific technology as the predicate device.
§ 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.