(55 days)
The ARx Illiac Spinal Screw System, is intended for posterior pedicle screw fixation of the non-cervical posterior spine (T1 to S2/ilium) in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis . It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
When used as a posterior spine thoracic/lumbar system, the ARx Illiac Spinal Screw System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures and spinal deformity (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (pseudarthrosis), (6) spinal stenosis, (7) spondylolisthesis.
In order to achieve additional levels of fixation in skeletally mature patients, the ARx Illiac Spinal Screw System 5.5/6.0 rod system may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod.
The ARx Illiac Spinal Screw System consists of screws and longitudinal rods intended to provide temporary stabilization and immobilization following surgery to fuse a portion of the thoracic, lumbar, and/or sacral spine. The ARx Illiac Spinal Screw System consists of an assortment of rods and screws. The bone screw, head, and taper lock are assembled together during manufacturing to create the ARX Illiac Spinal Screw System screw assembly component. The ARx Illiac Spinal Screw System implant components are made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 and Cobalt Chrome (Co-28Cr-6Mo) as described by ASTM F1537. Do not use any of the ARx Illiac Spinal Screw System components with the components from any other system or manufacturer.
This document is a 510(k) premarket notification for the "ARx Illiac Spinal Screw System," a medical device used for spinal fixation. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through mechanical performance testing.
Here's the breakdown of the requested information, which can be extracted directly from the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that the testing was performed "to demonstrate substantially equivalent mechanical performance as compared to the Life Spine Arx (K200070)." This implies that the acceptance criteria for the ARx Illiac Spinal Screw System were to meet or exceed the performance of the predicate device (Life Spine Arx, K200070) for each tested parameter. Specific quantitative acceptance criteria are not provided in this summary, but the type of tests performed are mentioned:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet or exceed predicate device performance for: | ARx Illiac Spinal Screw System's performance was |
| - Static Axial Grip (per ASTM F1798) | found to be substantially equivalent to Life Spine Arx |
| - Static Torsional Grip (per ASTM F1798) | (K200070) in the following tests: |
| - Static Flexion-Extension Moment Testing (per ASTM F1798) | - Static Axial Grip |
| - Static Compression Bending (per ASTM F1717) | - Static Torsional Grip |
| - Static Torsion (per ASTM F1717) | - Static Flexion-Extension Moment Testing |
| - Dynamic Compression Bending Testing (per ASTM F1717) | - Static Compression Bending |
| - Static Torsion | |
| - Dynamic Compression Bending Testing |
2. Sample sized used for the test set and the data provenance
The document does not specify the exact sample size used for the mechanical testing (e.g., number of screws, rods, or test constructs). It also does not explicitly state the provenance of the data (country of origin, retrospective or prospective). However, as this is a medical device approval in the U.S., it can be inferred that the testing was conducted to U.S. regulatory standards and likely performed by the manufacturer or a contracted lab. The data is generated from mechanical testing, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The "ground truth" for mechanical testing is established by standardized test methods (ASTM F1717 & F1798) and objective measurements using calibrated equipment, not by human experts interpreting results.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods are typically associated with human interpretation tasks (e.g., medical image reading) where there might be subjectivity or disagreement. Mechanical testing is objective and quantitative.
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
An MRMC comparative effectiveness study was not done. This study focuses on the mechanical performance of a spinal implant, not on the effectiveness of an AI-assisted diagnostic or interpretative tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was not done. This is not an AI algorithm.
7. The type of ground truth used
The ground truth used for this study is mechanical test standards and objective measurements. Specifically, the performance of the ARx Illiac Spinal Screw System was compared directly against the mechanical performance of the predicate device (Life Spine Arx, K200070) as measured by established ASTM standards (ASTM F1717 & F1798).
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of mechanical performance testing for spinal implants. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of device and study.
§ 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.