(134 days)
The ANAX™ 5.5 SPINAL SYSTEM is a posterior, non cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:
- · Spondylolisthesis (Grade 3 and 4)
- · Degenerative spondylolisthesis with objective evidence of neurological impairment
- · Trauma (i.e., fracture or dislocation)
- · Spinal stenosis
- · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- · Pseudoarthrosis
- · Failed previous fusion
The ANAX™ 5.5 Spinal System is a top-loading multiple component, posterior spinal fixation system and minimally invasive surgery system which consist of pedicle screws, rods, set screws, connectors and a transverse (cross) linking mechanism. The ANAX™ 5.5 Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The ANAX™ 5.5 Spinal System components are supplied non-sterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537). All pedicle screws have self-tapping function in ANAX™ 5.5 Spinal System The double lead thread is applied to the all pedicle screws to shorten the operation time. ANAX™ 5.5 Spinal System with CoCr rods may be used to provide immobilization and stabilization of spinal segment when the rigid system is need. (Recommendation: trauma or deformities) The product life time of ANAX™ 5.5 Spinal System is 2 years based on mechanical test result. The purpose of this submission is to add uniplanar screws and connectors to the ANAX™ 5.5 Spinal System.
The FDA 510(k) summary for the ANAX™ 5.5 Spinal System (K231737) indicates that the device's performance was evaluated through mechanical testing to demonstrate substantial equivalence to its predicate devices. Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the mechanical performance of the ANAX™ 5.5 Spinal System "met the acceptance criteria which have been established from the predicate device." However, the specific quantitative acceptance criteria values (e.g., specific load values, deflection limits, or number of cycles) are not explicitly provided in the excerpt. Similarly, the reported quantitative device performance data is also not presented in the document. The summary only states that the device "met all acceptance criteria."
| Test Performed | Acceptance Criteria (Not explicitly stated, but "established from predicate device") | Reported Device Performance (Not explicitly stated, but "met all acceptance criteria") |
|---|---|---|
| Static compression bending test (ASTM F1717) | Based on predicate device (e.g., K173524, K162189, K143417, K132101) | Met acceptance criteria |
| Static torsion test (ASTM F1717) | Based on predicate device (e.g., K173524, K162189, K143417, K132101) | Met acceptance criteria |
| Compression bending fatigue test (ASTM F1717) | Based on predicate device (e.g., K173524, K162189, K143417, K132101) | Met acceptance criteria |
| Axial gripping capacity test (ASTM F1798) | Based on predicate device (e.g., K173524, K162189, K143417, K132101) | Met acceptance criteria |
| Axial torque gripping capacity test (ASTM F1798) | Based on predicate device (e.g., K173524, K162189, K143417, K132101) | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size (number of devices, components) used for each mechanical test. Mechanical tests typically involve multiple samples to ensure repeatability and statistical significance, but the exact numbers are not mentioned in this summary.
Data Provenance: The tests are described as "mechanical strength evaluation" and "performance testing" conducted to compare the proposed device with predicate devices. This is not clinical data, but rather laboratory-based engineering test data. The document does not specify the country of origin for the testing itself, but the manufacturer is based in Korea (Innosys Co., Ltd., Uijeongbu-si, Gyeonggi-do, Korea). These are not retrospective or prospective studies in the clinical sense, but rather benchtop studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable in the context of this 510(k) submission. The "ground truth" for mechanical performance is established by validated international standards (ASTM F1717, ASTM F1798) and comparison to previously cleared predicate devices, not by human expert consensus on clinical findings. Therefore, no experts were used to establish a "ground truth" in the way clinical diagnostic studies would.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or evaluators in clinical studies. Mechanical testing involves objective measurements against predefined criteria, not subjective interpretation requiring adjudication among experts.
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
This question is not applicable. The ANAX™ 5.5 Spinal System is a physical medical device (spinal fixation system), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
For the mechanical tests, the "ground truth" is defined by the specifications and performance characteristics of the predicate devices and the requirements outlined in the relevant ASTM standards (ASTM F1717 and ASTM F1798). The goal was to demonstrate that the proposed device performs equivalently to the predicate devices and meets established engineering standards for spinal fixation systems.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of mechanical testing for a physical implant. Training sets are typically used for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this type of device.
§ 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.