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The Responsive Arthroscopy Thunderbolt System is intended for soft tissue to bone fixation for the following indications:

Shoulder: Bankart lesion repair, SLAP lesion repairs, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps Tenodesis

Foot and Ankle: Medial/lateral repair and reconstruction, Mid-and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair, Ankle Syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures

Elbow: Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment

Knee: ACL/PCL repair/reconstruction, ACL/PCL patellar bone-tendon-bone grafts, Double-Tunnel ACL reconstruction, Extracapsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement. Joint capsule closure

Hand and Wrist. Collateral ligament repair. Scapholunate ligament reconstruction. Tendon transfers in phalanx. Volar plate reconstruction

Hip: Acetabular labral repair

The Responsive Arthroscopy Thunderbolt System is a knotless system for the fixation of soft tissue to bone. The system includes a suture-button implant assembly made of Ti-6Al-4V ELI per ASTM F136 and ultra high molecular weight polyethylene, an implantable two holed plate made of Ti-6Al-4V EU per ASTM F136, and instrumentation including drills and drivers. The implants and single-use instruments are provided sterile, and the reusable instruments are non-sterile and are to be sterilized by the end user.

This FDA 510(k) summary for the Responsive Arthroscopy Thunderbolt System does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML powered medical device.

The document describes a traditional medical device (a suture-button implant system) for soft tissue to bone fixation. The performance testing mentioned is for the physical characteristics of this implant, not for an AI algorithm's diagnostic or predictive capabilities.

Therefore, I cannot extract the requested information regarding AI/ML device performance, sample sizes, ground truth, expert qualifications, adjudication, or MRMC studies from this text. The "Performance Testing" section lists typical tests for an implantable medical device, such as static and cyclic pullout force, suture characterization, biocompatibility, sterility, packaging, shelf-life, and pyrogenicity. These are not relevant to the acceptance criteria for an AI/ML system's diagnostic or prognostic performance.

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