(303 days)
The Aaxter A3 Posterior Spinal System is intended for posterior pedicle and non-pedicle fixation in the non-cervical spine as an adjunct to fusion in skeletally mature patients for the following indication: spondylolisthesis (Grade 3 and 4), of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft having implants attainment to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.
In addition, the Aaxter A3 Posterior Spinal System is 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 of the vertebral body
· Dislocation
· Scoliosis
· Kyphosis
· Spinal tumor
The Aaxter A3 Posterior Spinal System is a posterior spinal system which is a top loading multiple components, posterior pedicle and hook fixation system intended to provide segmental stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.
The Aaxter A3 Posterior Spinal System consists of variety of rods, hooks, screws, and cross links used to build a spinal construct for stabilization and promotion of spinal fusion in the thoracic-lumbar and sacral regions.
The Aaxter A3 Posterior Spinal System implant system components are supplied non-sterile for single use and are made from medical titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. Specialized instruments made from surgical grade stainless steel are used for all the operations of the Aaxter A3 Posterior Spinal System.
Here's a breakdown of the acceptance criteria and study information for the Aaxter A3 Posterior Spinal System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criterion | Device Performance |
---|---|
Mechanical Performance: | |
Static Compression Bending (per ASTM F1717) | Substantially equivalent to legally marketed predicate devices. |
Static Torsion (per ASTM F1717) | Substantially equivalent to legally marketed predicate devices. |
Dynamic Compression Bending (per ASTM F1717) | Substantially equivalent to legally marketed predicate devices. |
Pullout Testing (per ASTM F1798) | Substantially equivalent to legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the exact sample sizes (e.g., number of test constructs, individual screws, rods) for each mechanical test. It only states that these tests were performed according to ASTM standards.
The data provenance is not explicitly mentioned. Given it's a regulatory submission from a company in Taiwan (Aaxter Co., Ltd), the testing was likely conducted in a lab affiliated with the company or a certified testing facility, potentially within Taiwan or another country capable of performing the specified ASTM tests. This was a retrospective evaluation as it was part of a 510(k) submission, confirming the device's substantial equivalence to existing devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device submission. The "ground truth" for a mechanical orthopedic implant like the Aaxter A3 Posterior Spinal System is established through adherence to recognized international standards (ASTM F1717 and ASTM F1798) and comparison to predicate devices, rather than expert clinical consensus or pathological review of patient data. The "ground truth" here is the performance metrics defined by the standards and the performance of previously cleared devices.
4. Adjudication Method (for the test set)
This information is not applicable. Mechanical tests against standards do not typically involve adjudication in the human expert sense. The results are objective measurements compared against specified criteria and predicate device data.
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 used for diagnostic algorithms or imaging interpretation, not for mechanical orthopedic implants.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This information is not applicable. This device is a physical pedicle screw spinal system and does not involve algorithms or AI.
7. The Type of Ground Truth Used
The "ground truth" for the performance data in this submission is the mechanical performance standards (ASTM F1717 and ASTM F1798) and the performance characteristics of legally marketed predicate devices. The goal was to demonstrate "substantial equivalence" to these benchmarks.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not an AI or algorithm-based system that requires a "training set" in the machine learning sense. The design and manufacturing processes are informed by engineering principles and material science, not data training.
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.