(68 days)
The Facilis™ Spinal System is intended for posterior, non-cervical fixation to provide immobilization 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 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, and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion. The Facilis™ Spinal System is to be used with autograft and/or allograft.
The Facilis™ Spinal System is a system that is indicated for multiple types of spinal fusion procedures (please see Section IV). All components are made from titanium alloy Titanium-6 Aluminum-4 Vanadium (Ti-6AL-4V), a biocompatible material which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, hooks and accessory connection components. The Facilis™ Spinal Systems are supplied "Non-Steriled" and must be sterilized before use.
This document describes the Facilis™ Spinal System, a medical device, and its acceptance criteria as proven by a study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing | All testing results passed acceptance criteria in accordance with ASTM F1717 and ASTM F1798. |
| Substantial Equivalence to Predicate Device | The device demonstrates substantial equivalence to the predicate device (Facilis™ Spinal System K161231) based on shared operating principles, fundamental scientific technology, materials, shelf life, packaging, and manufacturing process, with additional component types. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes mechanical testing performed for the device. The "test set" in this context refers to the physical samples of the Facilis™ Spinal System components used for these mechanical durability tests.
- Sample Size: Not explicitly stated as a number of devices or components. It refers to "the subject Facilis Spinal System with its components and the predicate devices."
- Data Provenance: The tests were conducted according to established ASTM standards (F1717 and F1798), implying laboratory-based testing rather than clinical data from human patients. The origin of the specific tested devices is not specified beyond being the subject device and predicate devices. This would be considered prospective data generation for the purpose of demonstrating mechanical performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable to a mechanical performance study. "Ground truth" established by experts typically refers to clinical diagnoses or interpretations. For mechanical testing, the "ground truth" is defined by the physical properties and performance limits set forth in the ASTM standards.
4. Adjudication Method for the Test Set
This information is not applicable to a mechanical performance study. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving expert consensus on diagnoses or interpretations. For mechanical testing, the results are objectively measured against predefined criteria in the ASTM standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, which is not the subject of this medical device submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone performance study was not done. This submission is for a physical medical device (spinal system), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the mechanical testing was the acceptance criteria established by recognized industry standards (ASTM F1717 and ASTM F1798). These standards define the mechanical properties and performance requirements for spinal implant systems. The devices were tested to ensure they met these predefined physical and mechanical thresholds.
8. The Sample Size for the Training Set
This information is not applicable. This is a submission for a physical medical device. The concept of a "training set" is relevant for AI/machine learning models, not for traditional medical devices undergoing mechanical performance testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
§ 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.