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The Tenon Medical Catamaran SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including:

• Sacroiliac joint disruptions and degenerative sacroiliitis
• To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The Catamaran SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The Catamaran SI Joint Fusion System was developed as a less invasive alternative to traditional open posterior surgical SI Joint fusion. The system consists of the Catamaran SI Joint Fixation Implant (Ti6A1-4V ELI Titanium alloy / ASTM F136) included in a reusable System Tray containing: Access, Drill and Delivery, Bone Graft Packing, and Extraction Instruments. The Catamaran SI Joint Fixation Implants are designed in various widths and lengths, and allow autologous bone graft material placement in the barrels of the implant to support SI Joint fixation and fusion. The Instrument Set includes Class II single use and reusable surgical instruments designed to facilitate placement of the implant within the sacroiliac joint using an inferior-posterior surgical approach. The implants and associated instruments are provided clean and non-sterile and are designed for steam sterilization prior to use.

This document is a 510(k) Premarket Notification from the FDA regarding the Tenon Medical CATAMARAN™ SI Joint Fusion System. Based on the provided text, the submission does not include any study data relating to the performance of an AI/ML medical device.

The central point of this 510(k) submission is a change in the Indications for Use for an already cleared device. The text explicitly states:

• "The sole purpose of this submission is to modify the indications for use." ([Page 5])
• "No clinical or non-clinical performance testing was necessary to support the change in indications for use proposed." ([Page 5])

Therefore, I cannot extract the information required by your request about acceptance criteria and a study proving a device meets them, as this document concerns a change to an existing device's labeling and did not involve new performance testing.

If you have a document related to an AI/ML device approval that includes performance study data, please provide that.

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