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The Vy Spine™ VyWasher™ Buttress System is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

The Vy Spine™ VyWasher™ Buttress System is a temporary implant used to prevent bone graft extrusion. The Vy Spine™ VyWasher™ Buttress System consists of washers and bone screws. The Vy Spine™ VyWasher™ Buttress System is also intended to provide stabilization and augment development of a solid spinal fusion. The Vy Spine™ VyWasher™ Buttress System fixates to the anterior portion of the thoracolumbar vertebral body. The construct may be employed alone, or with other anterior, anterolateral, or posterior spinal systems made of compatible materials.

This FDA 510(k) summary does not contain the information required to answer your request. The document describes a spinal fixation orthosis (Vy Spine™ VyWasher™ Buttress System) which is a physical medical device, not a device that relies on algorithms or AI for performance.

Therefore, the following information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for software-based medical devices or AI algorithms, are not present in this submission:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers' improvement with AI vs. without AI assistance.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Instead, this document focuses on establishing substantial equivalence for a physical implantable device based on material, design, sizes, intended use, and biocompatibility compared to predicate devices, along with non-clinical testing (which would typically involve mechanical or material strength testing, not clinical performance against ground truth).

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