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The Stryker Spine AVS PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS PL PEEK Spacers are to be implanted via posterior approach.

The AVS PL PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

This Special 510(k) premarket notification is intended to introduce the following design changes to the 0° AVSTM PL PEEK Spacers: The ogival shaped nose of the implant has been changed to a tapered design to facilitate insertion. The threaded hole on the front side of the implant has been omitted as it is not needed to remove the implant and field feedback confirms it would likely not be used. In the smaller heights, the back sided threaded hole has been adapted to remain consistent with the existing instruments (i.e., the two Inserters), and the back side of the spacer has been tapered in the frontal plane to match the geometry of the vertebral endplates and the two flat surfaces have been increased to improve connection with the Inserters. Note that the AVS PL PEEK Spacers are also referred to as AVS Plus.

I'm sorry, but based on the provided text, I cannot describe the acceptance criteria or a study proving the device meets them. The document is primarily a "Special 510(k) Summary of Safety and Effectiveness" for modifications to an existing spinal implant system, not a detailed study report with specific performance metrics and acceptance criteria.

Here's why the requested information cannot be extracted:

• Acceptance Criteria and Reported Device Performance: The document states that "Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed for the AVS PL PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems." However, it does not provide a table of specific acceptance criteria (e.g., minimum compression strength, fatigue life) or the numerical 'reported device performance' values for these criteria. It only indicates that the device met the requirements for substantial equivalence.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): None of these details are present in the provided text. The document is a regulatory submission summary, not a scientific paper detailing the methodology and results of specific tests with a test set. It mentions "mechanical testing results" but does not elaborate on the specifics of these tests as would be required to answer your questions.
• Training Set Information: Similarly, there is no mention of a training set, how its ground truth was established, or its sample size. This type of information is relevant for AI/machine learning models, which are not described as being part of this device or its evaluation. This device is a physical intervertebral body fusion device.

In summary, the provided text confirms that certain tests were conducted to demonstrate substantial equivalence to a predicate device, but it lacks the granular detail about acceptance criteria, performance metrics, and study methodologies that you are requesting.

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