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The OrthADAPT® Bioimplant (Surgical Mesh) is intended to be used for implantation to reinforce soft tissue including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and other reconstructive procedures.

The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

OrthADAPT® is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair,

OrthADAPT® is intended for one-time use only.

The OrthADAPT Bioimplant is a decellularized, equine pericardium. The OrthADAPT Bioimplant has been crosslinked and exposed to a liquid chemical sterilant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use.

The provided text is a 510(k) summary for the OrthADAPT® Bioimplant, a surgical mesh. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text.

The 510(k) summary clearly states:
"Supplier qualification activities, receiving controls, and design verification testing demonstrate that the modified OrthADAPT Bioimplant device is equivalent to the predicate device in terms of design, performance and intended use."

This indicates that the device was deemed "substantially equivalent" based on a comparison to an already cleared device (K043388), rather than through a new clinical or performance study with defined acceptance criteria for a novel device.

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