(387 days)
The ART2 Spinal Fixation System is a pedicle screw system 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).
As a pedicle screw system ART2 Spinal Fixation System is indicated for the treatment of severe spondylolisthesis (Grades 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.
The ART2 Spinal Fixation System has been developed with the objective of providing the surgeon with an adaptable pedicle screw system in order to carry out posterior pedicle screw fixation of the spine simply, quickly and effectively. It is a modification of the ART Pedicle Screw system (K033150).
The system consists of a variety of color coded top loading pedicle screws. The pedicle screws are available in various lengths and diameters. The screw is connected to the rod connector. Two sizes of connectors are available, short and long. The long is used in cases of spondylolisthesis where the short connector would not be able to engage the rod. The rods are available in multiple lengths.
The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136.
The provided document describes the ART2 Spinal Fixation System, a pedicle screw system. The acceptance criteria and the study proving it meets these criteria are outlined in the "Summary of Nonclinical Tests" section.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Study | Acceptance Criteria (from ASTM Standards) | Reported Device Performance |
|---|---|---|
| Static and dynamic compression | Met criteria laid out in ASTM F1717 | "The acceptance criteria was/were met." (Implies the ART2 system performed comparably or better than the predicate devices and passed the ASTM F1717 requirements) |
| Static torsion | Met criteria laid out in ASTM F1717 | "The acceptance criteria was/were met." (Implies the ART2 system performed comparably or better than the predicate devices and passed the ASTM F1717 requirements) |
| Static Axial Slippage | Met criteria laid out in ASTM F1798 | "The acceptance criteria was/were met." (Implies the ART2 system performed comparably or better than the predicate devices and passed the ASTM F1798 requirements) |
| Static Torsional Slippage | Met criteria laid out in ASTM F1798 | "The acceptance criteria was/were met." (Implies the ART2 system performed comparably or better than the predicate devices and passed the ASTM F1798 requirements) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of devices or tests performed) for each specific test or the data provenance (country of origin, retrospective/prospective). It only mentions what tests were conducted and that the acceptance criteria were met. For non-clinical, mechanical testing like this, the "test set" would refer to the number of devices or components subjected to each test type. The data provenance would be from laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a submission for a spinal fixation system, which involves mechanical safety and performance testing, not diagnostic or interpretive tasks where expert ground truth would be established from patient data. The "ground truth" here is compliance with established ASTM (American Society for Testing and Materials) standards for medical devices.
4. Adjudication Method for the Test Set
Not applicable. As this is mechanical testing against an engineering standard, there is no human adjudication process involved. The results are quantitative measurements compared against predefined thresholds in the ASTM standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study with human readers was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is a medical device (spinal fixation system) for surgical implantation, not a software algorithm that operates without human intervention. The testing described is mechanical, material, and functional testing of the physical device.
7. Type of Ground Truth Used
The ground truth used for performance validation is based on established engineering and material standards, specifically:
- ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model)
- ASTM F1798 (Standard Test Method for Static and Dynamic Axial Compression-Shear, Torsion, and Combined Loading Fatigue Tests of Spinal Intervertebral Body Fusion Devices)
These standards define methods and acceptance criteria for mechanical properties of spinal implants.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or machine learning model. Therefore, there is no "training set" in the context of data for model development. The design and manufacturing process would involve extensive engineering and material science, but not in the way of a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model. The "ground truth" for the device's design and functionality would be based on biomechanical principles, material science, clinical requirements for spinal stabilization, and previous generations of similar devices (the predicate devices).
§ 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.