(472 days)
The ESPINAX CORPECTOMY CAGE is intended for use in skeletally mature patients in the cervical spine (C2-T1) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The DISTRACTANIA CORPECTOMY CAGE is intended for use in skeletally mature patients in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The ESPINAX and DISTRACTANIA CORPECTOMY CAGES are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The ESPINAX and DISTRACTANIA CORPECTOMY CAGES are intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material is optional.
The ARTFX CORPECTOMY CAGE includes product range for cervical and lomber applications.
ESPINAX SPINAL CERVICAL CORPECTOMY CAGE is used in cervical spine (C2- T1)
ESPINAX SPINAL CERVICAL CORPECTOMY CAGE-ANGLED
DISRACTANIA SPINAL LUMBAR CORPECTOMY CAGE
DISRACTANIA SPINAL LUMBAR CORPECTOMY CAGE-ANGLED is used in lumber spine (T1-L5)
ESPINAX SPINAL CERVICAL CORPECTOMY CAGE is used in cervical spine (C2- T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
DISRACTANIA SPINAL LUMBAR CORPECTOMY CAGE is used , in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectorned to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
ARTFX CORPECTOMY CAGE consisting of two parts, can easily be placed between the vertebra are the features to be distraction. Product is available in the cervical and lumbar spine, the upper and lower vertebrae, providing one to one contact with the angled surface. With gear structure with full contact surfaces of vertebrae forming the product surface, providing a tighter grip, eliminating the risk of slipping. Distraction prior to graft area at that provide a locking device which has a single-stage system after distraction.
The ARTFX CORPECTOMY CAGE, vertebral structure is used in cases where a portion or all of the damage. This damages the vertebral structure, tumors, fractures, and infections may occur due to.
The ARTFX CORPECTOMY CAGE is supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to the ISO 5832-2 and ASTM F136 .Various sizes of these components are available.
The provided document is a 510(k) summary for the ArtFx Corpectomy Cages, a medical device. This document does not describe a study involving AI or software performance. Instead, it focuses on the substantial equivalence of the ArtFx Corpectomy Cages to a predicate device based on non-clinical mechanical testing.
Therefore, many of the requested categories related to AI performance, such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, and training set information, are not applicable to the content of this document.
However, I can provide information about the acceptance criteria and the study that proves the device meets those criteria based on the non-clinical testing described.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical terms within this 510(k) summary (e.g., "The device must withstand X N of compression"). However, the summary indicates that non-clinical testing was performed "according to the Guidance for Industry and FDA Staff Spinal System 510(k)s." This implies that the acceptance criteria are adherence to the performance requirements outlined in the specified ASTM standards and FDA guidance for spinal systems.
The reported device performance is that these tests were "performed" and presumably met the requirements of these standards to demonstrate substantial equivalence to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Adherence to ASTM F2077 for dynamic & static compression, shear, and torsion tests | Tests performed according to ASTM F2077. |
| Adherence to ASTM F2267 for subsidence testing | Subsidence test performed according to ASTM F2267. |
| Successful expulsion testing | Expulsion test performed. |
| Overall mechanical performance substantially equivalent to predicate device | Concluded as substantially equivalent to predicate device K192117 based on testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document only mentions "Non-clinical testing including below tests are performed". For mechanical testing of medical devices, the "sample size" typically refers to the number of devices or representative constructs tested for each specific test. This specific number is not explicitly stated in the provided 510(k) summary.
Data Provenance: Not applicable as this is non-clinical mechanical testing, not human data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth establishment with experts is relevant for clinical studies or AI/diagnostic device performance evaluation, not for mechanical device testing.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are relevant for clinical studies or AI/diagnostic device performance evaluation, not for mechanical device testing.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. An MRMC study involves human readers interpreting cases, often with and without AI assistance. This document describes non-clinical mechanical testing of a physical medical device (corpectomy cages) and does not involve AI, human readers, or cases in this context.
6. Standalone Performance Study
Yes, in a sense, the non-clinical tests described (Dynamic Compression, Static Compression, Subsidence, Expulsion tests) represent a "standalone" evaluation of the device's mechanical performance without human interaction during the test itself. The performance is assessed against established engineering standards rather than against human performance.
7. Type of Ground Truth Used
The "ground truth" for this type of testing is established through industry standards and regulatory guidance. The device's performance is compared against the requirements and specifications outlined in the ASTM standards (F2077, F2267) and FDA guidance for spinal systems, which define acceptable mechanical properties and behaviors for such devices.
8. Sample Size for the Training Set
Not applicable. There is no AI or machine learning component mentioned that would require a training set. This is a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.