(95 days)
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine. The components in the Solanas Posterior Stabilization System can be linked to the components in the Zodiac Polyaxial Spinal Fixation System offered by Alphatec Spine using the Axial Rod Connectors, Parallel Rod Connectors or Transitional Rods
- l Degenerative disk disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
- 트 Spondylolisthesis
- . Spinal Stenosis
- 트 Fracture/Dislocation
- Atlanto/Axial fracture with instability
- 트 Revision of previous cervical spine surgery
- 트 Tumors
The SOLANAS III™ Posterior Stabilization System is a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
Acceptance Criteria and Device Performance for SOLANAS™ Posterior Stabilization System
Based on the provided 510(k) summary for the SOLANAS™ Posterior Stabilization System, the device's acceptance criteria and the study proving its performance are primarily based on substantial equivalence through mechanical and dynamic testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance similar to legally marketed predicate devices. | Mechanical and dynamic testing of the posterior stabilization system was performed. The test results demonstrate that the mechanical performance of the SOLANAS III™ Posterior Stabilization System is substantially equivalent to the predicate devices (K052201). |
| Dynamic performance similar to legally marketed predicate devices. | Mechanical and dynamic testing of the posterior stabilization system was performed. The test results demonstrate that the mechanical performance of the SOLANAS III™ Posterior Stabilization System is substantially equivalent to the predicate devices (K052201). |
| Meeting established standards for spinal fixation systems. | (Implicit in substantial equivalence and FDA clearance process, but specific standard numbers are not detailed in the provided text.) |
| Biocompatibility (implied for implantable devices). | (Implicit in substantial equivalence and FDA clearance process, but specific test results are not detailed in the provided text.) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for the "mechanical and dynamic testing." The data provenance is also not explicitly stated beyond the fact that testing was performed. However, for mechanical and dynamic testing of medical devices in a regulatory submission, these tests are typically conducted in a laboratory setting, not with human or animal subjects, and thus "country of origin of the data" or "retrospective/prospective" wouldn't apply in the same way as clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of information is not applicable to the provided performance data. Mechanical and dynamic testing of spinal implants typically involves engineering and material science experts, not medical experts establishing ground truth in the diagnostic sense. The "ground truth" for these tests would be established by validated test methods and established engineering specifications.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (e.g., 2+1, 3+1) is not applicable to mechanical and dynamic testing of devices. Adjudication methods are used in clinical trials or studies where human interpretation or consensus is required to establish an outcome or ground truth.
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. The device described is a spinal fixation system (hardware); it is not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.
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 device is a physical implant, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the mechanical and dynamic testing would have been established by recognized engineering standards and validated test methodologies used to assess the strength, durability, and functional performance of spinal fixation systems. The comparison is made against the performance of legally marketed predicate devices, implying that the predicate devices also met these types of engineering "ground truths."
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this type of device. Training sets are used in machine learning or AI algorithm development. This device's performance is established through physical testing, not algorithmic learning.
9. How the Ground Truth for the Training Set was Established
As noted above, the concept of a "training set" and its associated "ground truth" is not applicable to this medical 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.