(90 days)
The TRIWAY® TTC Arthrodesis System is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include:
- Post-traumatic and degenerative arthritis involving both ankle and subtalar joints
- Rheumatoid arthritis with severe deformity
- Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
- Revision of failed total ankle arthroplasty with subtalar intrusion
- Talar deficiency conditions, including avascular necrosis (requiring a tibiocalcaneal arthrodesis)
- Neuroarthropathy or neuromuscular deformity or other neuromuscular disease with severe deformity of the ankle, including Charcot foot
- Severe pilon fractures with trauma to the subtalar joint
- Malunited tibial pilon fractures
The addition of an IBS™ 6.5mm compression screw through the subtalar joint and through the nail is required.
The TRIWAY® Tibiotalocalcaneal (TTC) Arthrodesis System is composed of an angulated nail available in several sizes and different screws for bony fixation. Rigid fixation is achieved by screws.
An instrument set is available for the bone preparation, screw sizing and insertion of the TRIWAY® TTC Arthrodesis System. A specific targeting device is available for the positioning and the insertion of the different cotter screws and the I.B.S® 6.5mm compression screw, which is inserted in an oblique way to provide additional compression throughout the nail, between the calcaneus and the talus.
Sizes:
The TRIWAY® Arthrodesis Nail is available in several sizes, with left and right versions (diameter 10, 11, 12mm, lengths from 160mm to 250mm).
Cotter screws are available in 5.0mm diameter, with length ranging from 25 to 110mm by 5mm increment.
Material: The TRIWAY® TTC Arthrodesis System implants (nail and screws) are manufactured from Ti6Al4V, as per ISO 5832-1 and ASTM F136.
Single use: The TRIWAY® TTC Arthrodesis System is designed for single use only.
Sterilization: The TRIWAY® TTC Arthrodesis System is supplied sterile, using gamma irradiation.
The provided text is a 510(k) premarket notification for a medical device (TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System) and discusses its substantial equivalence to predicate devices, focusing on mechanical performance and material properties. It does not describe an AI medical device or a study involving human readers or expert ground truth for image interpretation. Therefore, I cannot extract the information required by your requests, as those particulars relate to the evaluation of AI-powered diagnostic or assistive devices.
The document discusses:
- Device description: An intramedullary fixation rod system for tibiotalocalcaneal arthrodesis.
- Material: Ti6Al4V, as per ISO 5832-1 and ASTM F136.
- Sterilization: Gamma irradiation, supplied sterile.
- Performance testing: "Performance testing of the TRIWAY® TTC Arthrodesis System was assessed through mechanical bench testing performed by an independent test laboratory. Testing performed included static and dynamic bending tests on TRIWAY® TTC Arthrodesis System. The results indicate that the TRIWAY® TTC Arthrodesis System met the acceptance criteria."
- Pyrogen testing: Limulus Amebocyte Lysate (LAL) test in accordance with ANSI/AAMI ST72:2011.
It does not contain information about:
- Acceptance criteria for an AI device.
- Device performance metrics like accuracy, sensitivity, or specificity for an AI.
- Sample sizes for test or training sets for an AI.
- Data provenance (country, retrospective/prospective) for an AI.
- Number of experts or their qualifications for establishing ground truth for AI.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Types of ground truth (e.g., pathology, outcomes data) for an AI training set.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.