Search Results

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.

Ask a specific question about this device

The Tenon Medical CATAMARAN™ SI Joint Fusion System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.

The CATAMARAN SI Joint Fusion System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis. 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 sacroillac joint using an inferiorposterior surgical approach. The implants and associated instruments are provided clean and non-sterile and are designed for steam sterilization prior to use.

The provided text is a 510(k) summary for a medical device (CATAMARAN™ SI Joint Fusion System) and does not contain information about studies evaluating an AI/ML-driven device, particularly regarding acceptance criteria, sample sizes for test/training sets, expert involvement, or MRMC studies.

Therefore, it is impossible to describe "the acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML performance from the provided document. The document primarily focuses on demonstrating substantial equivalence to a predicate device, and the "study" mentioned pertains to MR compatibility testing, not clinical performance or AI/ML algorithm validation.

The "Design Verification Standards Testing" section (page 5) lists ASTM standards for MR compatibility assessment. This is a crucial part of the device's validation but doesn't involve the kind of performance metrics or expert reviews associated with AI/ML diagnostic or prognostic tools.

The prompt's request for information on "acceptance criteria and the study that proves the device meets the acceptance criteria" (specifically for an AI/ML device), along with details like "sample size used for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "ground truth type," and "training set details," cannot be addressed using the provided text.

Ask a specific question about this device