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The Zavation ALIF System is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Zavation ALIF System is to be filled with autogenous bone graft material.

The Zavation ALIF System spacer and plate assembly are an integrated for stand-alone use when used with screws. When used with anchors only the recessed plate may be used, and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.

Hyperlordotic interbody devices (>20 dogrees) must be used with supplemental fixation (c.g. posterior fixation) that has been cleared by the FDA for the use in the lumbar spine.

The Zavation ALIF System includes a spacer, plate, screws, and anchors. The spacer component is assembled to an interbody plate and implanted anteriorly. The spacer components are available in a variety of materials, depths, widths, and heights. The plate component includes three or four holes for inserting bone screws or anchors. The plate component also includes a lock at each hole. The bone screws are available in a variety of diameters and lengths. The anchors are available in a variety of lengths. The interbody plate components are available in a variety of heights.

The provided text does not contain information about acceptance criteria and the study that proves a device meets them in the context of an AI-powered medical device. Instead, it is a 510(k) premarket notification summary for the Zavation ALIF System, which is an intervertebral body fusion device (a physical implant) and not an AI device.

Therefore, I cannot extract the requested information like expert qualifications, adjudication methods, MRMC studies, or training/test set details, as these are specific to the evaluation of AI/ML-based medical devices.

The document discusses the mechanical performance of the physical implant against ASTM standards, but not the performance of an AI algorithm. If you have a document describing an AI device's performance study, please provide it.

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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.

Ask a specific question about this device