(29 days)
The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System are 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 autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System are 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 (pseudarthrosis).
The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System are a toploading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) linking mechanism.
The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion, 4CIS® SOLAR Spine System and 4C1S® APOLLON Spine System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System:
Based on the provided document, the device described is a pedicle screw spinal fixation system, which is a mechanical implant rather than an AI/software device. Therefore, the questions related to AI device performance (MRMC studies, standalone algorithm performance, AI data provenance, number of experts for ground truth, etc.) are not applicable to this submission.
The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, especially for additional sizes and shapes of an existing system. The primary method for proving this equivalence for a mechanical device like this is through mechanical testing.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical soundness in accordance with ASTM F1717 | Mechanical testing demonstrates equivalence to the predicate device and indicates that the products are as mechanically sound as the predicate device. |
Study Information (Relevant to a Mechanical Device Submission)
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated as a numerical sample size for a "test set" in the context of clinical trials or data-driven AI. Instead, the "test set" refers to the specific components (additional poly-axial pedicle screw sizes, additional rod sizes, additional insertion set instruments) that were subjected to mechanical testing. The number of these specific components tested is not quantified in this summary.
- Data Provenance: The data comes from mechanical testing conducted in accordance with ASTM F1717. The location of the testing is not specified, but the sponsor is Solco Biomedical Co., Ltd. in the Republic of Korea. It is not "retrospective" or "prospective" in the sense of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For mechanical testing, "ground truth" is typically established by the specifications and standards (e.g., ASTM F1717) themselves, and the results are objectively measured. Expert consensus in the context of clinical interpretation or diagnosis of images is not relevant here.
4. Adjudication method for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human review of data, particularly in clinical studies or image interpretation. For mechanical testing, the results are derived from physical measurements and comparisons to predefined thresholds/standards.
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. This is a mechanical device, not an AI or software device. MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a mechanical device. Standalone algorithm performance is not relevant.
7. The type of ground truth used:
- For mechanical devices and equivalence claims based on mechanical testing, the "ground truth" is typically the established limits and performance characteristics of the predicate device and the requirements outlined in the relevant ASTM standards (ASTM F1717). The device's performance is measured against these objective, quantifiable standards.
8. The sample size for the training set:
- Not Applicable. This is a mechanical device. There is no concept of a "training set" in the context of an algorithm's development for this type of submission.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI algorithm for this mechanical device, this question is not relevant.
§ 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.