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Each BONE GRAFT WASHER is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials (e.g., commercially pure titanium or titanium alloy).

The BONE GRAFT WASHER is used with a 6.5mm low profile screw to provide bone graft stabilization during the development of a solid spinal fusion. Instrumentation is also available to facilitate implantation of the device components.

BONE GRAFT WASHER components are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3. The BONE GRAFT WASHER may also be fabricated from commercially pure titanium described by such standards as ASTM F67 or ISO 5832-2. The implant components may be sold either sterile or non-sterile.

This document is a 510(k) summary for a medical device called the "BONE GRAFT WASHER." It's a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it does not contain acceptance criteria for device performance or a study demonstrating that the device meets those criteria.

Instead, the summary focuses on:

• Description of the device: What it is, what it's made of.
• Intended Use/Indications for Use: What the device is for.
• Substantial Equivalence: A statement that it's equivalent to other accepted devices.

Since the document is a 510(k) summary and not a clinical study report or a detailed performance validation, the specific information requested in your prompt (acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not present within the provided text.

The FDA's finding of "substantial equivalence" in a 510(k) process typically relies on demonstrating that the new device has the same intended use, technological characteristics, and performance (or can be shown to be as safe and effective) as a predicate device, rather than requiring new, extensive clinical trials with pre-defined acceptance criteria for novel device performance. Performance testing might be referenced, but the acceptance criteria and detailed study results as you've requested are not part of this summary.

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