(55 days)
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.