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To provide fixation to bone of the tibial and/or femoral end of a bone-patellar tendon-bone graft or other soft tissue graft material used to reconstruct the ACL and/or PCL in an intraarticular procedure of the knee.

The Soft Tissue Suture Washer is a titanium alloy (Ti-6A1-4V) three-hole suture washer that is intended to be used with cancellous or cortical bone screws. This suture washer is designed to prevent migration of screw head into the bone and provide an anchoring site for sutures.

The provided document K991135 is a 510(k) Pre-Market Notification for a medical device called the "Soft Tissue Suture Washer." This document focuses on demonstrating substantial equivalence to a previously cleared device, rather than presenting a study that proves the device meets specific acceptance criteria through performance testing.

Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving device performance.

Instead, the submission states:

• Substantial Equivalence Basis: "The determination of substantial equivalence for this device was based on a detailed device description, and conformance with voluntary performance standard ASTM F136."
• Predicate Device: The Soft Tissue Suture Washer is substantially equivalent to the current DePuy OrthoTech Soft Tissues Suture Washer (K910229).

This means that the device's acceptability is based on its similarity to a device already on the market (the predicate device) and its compliance with a consensus standard (ASTM F136) which likely covers mechanical properties or material specifications for such devices. The document does not describe a clinical study or a performance study with defined acceptance criteria and statistical analysis as is typical for demonstrating efficacy or safety in other types of submissions.

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