(264 days)
FORTIFY® and FORTIFY® Integrated Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5). FORTIFY® Spacers (titanium) are also intended for use in the cervical spine (C2-T1). All FORTIFY® TPS coated spacers are indicated for the same use as non-coated PEEK versions.
When used in the cervical spine (C2-T1), FORTIFY® devices (titanium) are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal tissues in cervical degenerative disorders. These spacers are 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 turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
When used in the thoracolumbar spine (T1-L5), FORTIFY® Integrated devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to turnor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.
These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.
FORTIFY® Corpectomy Spacers are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The spacers include a central core and endplates, which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and the endplates can be preoperatively or intraoperatively assembled to best fit individual requirements. Each spacer has an axial hole to allow autogenous bone graft or allograft comprised of cancellous or corticocancellous bone graft to be packed inside of the spacer. Protrusions (teeth) on the superior and inferior surface grips the endplate of the adjacent vertebrae to resist expulsion. FORTIFY® Variable Angle endplates provide adjustable lordosis/kyphosis.
The provided text is a 510(k) summary for a medical device called "FORTIFY® Corpectomy Spacers." This document is focused on demonstrating the substantial equivalence of a new version of the device (with variable angle endplates) to previously cleared predicate devices.
It's crucial to understand that a 510(k) submission for a spinal implant device like this is primarily based on demonstrating mechanical and material equivalence to a predicate device, not on clinical performance metrics or AI algorithm validation. The questions you've asked (about acceptance criteria, AI performance studies, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, etc.) are typical for the validation of Artificial Intelligence/Machine Learning (AI/ML) based medical devices, especially those involved in image analysis or diagnostic support.
Therefore, based on the provided text, I cannot answer your specific questions related to AI/ML device validation. The information provided by the FDA for this particular 510(k) focuses on the mechanical and material aspects of the physical implant.
Here's a breakdown of why your specific questions cannot be answered from this document:
- No AI Component: The device described, FORTIFY® Corpectomy Spacers, is a physical spinal implant. It does not appear to involve any AI/ML components for image analysis, diagnosis, or treatment planning.
- Performance Data Type: The "Performance Data" section explicitly states: "Mechanical testing (static and dynamic compression, static and dynamic torsion, and expulsion) was conducted in accordance with ASTM F2077 and 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004. Performance data demonstrate substantial equivalence to the predicate device. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011." This confirms the performance data is related to the physical properties and biocompatibility of the implant, not to the performance of an AI algorithm.
- Focus on Substantial Equivalence: The entire submission's purpose is to show "substantial equivalence" to existing physical devices, meaning it works similarly, has similar indications, and performs mechanically as well as the predicate. This is a common pathway for new versions of existing medical devices and does not typically involve clinical trials or AI validation studies.
In summary, the provided document is for a traditional physical medical device and therefore does not contain the information requested about AI acceptance criteria and validation studies.
If you have a document describing an AI/ML medical device, please provide that, and I would be able to address your questions.
§ 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.