(139 days)
The Rexious Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for 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); tumor; pseudoarthrosis; and failed previous fusion. The Rexious Hook System can be used in conjunction with the Rexious Spinal Fixation System.
The Rexious Hook System is a top-loading posterior spinal fixation system which consists of hooks, rods, set screws, connectors and a transverse link system. The Rexious Hook System implant components are fabricated from titanium alloy (Ti6A14V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. The Rexious Hook System can be used in the posterior plane providing unilateral modes of fixation. The Rexious Hook System design allows adjustment in both the sagittal and coronal planes permitting hook placement according to the best possible anatomic location and orientation.
The Rexious Hook System's acceptance criteria and the study proving it meets these criteria are outlined below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Test Standard) | Reported Device Performance |
|---|---|
| Static Compression Bending (ASTM F1717) | Characterized |
| Static Tension (ASTM F1717) | Characterized |
| Static Torsion (ASTM F1717) | Characterized |
| Dynamic Compression Tests (ASTM F1717) | Characterized |
Note: The document states that these tests were "submitted to characterize the subject Rexious Hook System components." This implies that the device successfully met the performance benchmarks outlined in the ASTM F1717 standard for these specific tests, as the FDA granted substantial equivalence.
2. Sample Size and Data Provenance for Test Set
The provided text describes performance testing conducted according to ASTM F1717. However, it does not specify explicit sample sizes for these tests. The data provenance is not explicitly stated as 'retrospective' or 'prospective,' but given that it involved characterizing device components in a laboratory setting per ASTM standards, it is inherently a controlled, prospective engineering study. The study was conducted by DIO Medical Co., Ltd. in South Korea.
3. Number of Experts and Qualifications for Ground Truth
This type of submission (510(k) for a medical device like a spinal fixation system) does not typically involve the establishment of ground truth by clinical experts in the same way an AI/ML model study would. The acceptance criteria are based on engineering performance standards (ASTM F1717), which are evaluated through physical testing, not expert consensus on clinical data. Therefore, this section is not applicable.
4. Adjudication Method for Test Set
As the evaluation is based on objective physical performance tests against established standards (ASTM F1717), there is no adjudication method in the context of clinical expert review. The results are quantitative measurements interpreted against the ASTM F1717 standard's requirements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was conducted or reported in the provided documentation. This type of study is more relevant for diagnostic devices or AI algorithms that assist human interpretation, not for mechanical implantable devices.
6. Standalone Performance Study (Algorithm Only)
This point is not applicable. The Rexious Hook System is a physical medical device, not a software algorithm, so a "standalone (algorithm only)" study is not relevant. The performance studies conducted were on the physical device components.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is defined by the objective, quantifiable material and mechanical properties and performance criteria outlined in the ASTM F1717 standard (e.g., static compression bending, static tension, static torsion, and dynamic compression). These standards serve as the benchmark for the device's acceptable performance.
8. Sample Size for Training Set
There is no "training set" in the context of an AI/ML algorithm for this device. The development process would involve engineering design, material selection, and iterative physical prototyping and testing, not a data training set.
9. How Ground Truth for Training Set was Established
As there is no training set, this question is not applicable. The device's design and manufacturing are based on established engineering principles and materials science, with performance verified against industry standards like ASTM F1717.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.