(44 days)
The T2® Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:
- Post-traumatic or primary Arthrosis
- Previously infected arthrosis (second degree)
- Revision of Failed Ankle Arthrodesis
- Failed Total Ankle Replacement
- Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis)
- Neuroarthropathy or Neuromuscular Deformity or other neuromuscular disease with severe deformity or instability of the ankle
- Rheumatoid Arthritis with severe deformity such as rheumatoid hindfoot
- Ostheoartritis
- Nonunions or Pseudarthrosis of hindfoot and distal tibia
- Malunited tibial pilon fracture
- Charcot foot
- Severe endstage degenerative arthritis
- Severe defects after tumor resection
- Pantalar arthrodesis
This 510(k) submission is a line extension to the T2® Nailing System to add an ankle arthrodesis nail and additional accessories to the system. The nails are inserted using an opened or closed technique and can be locked in static, dynamic or compression mode. The T2® Ankle Nails and accessories are intended for sungle use only.
The provided text is a 510(k) summary for the T2® Ankle Arthrodesis Nail. It details the device's identification, description, intended use, and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study demonstrating the device meets such criteria.
The document states: "Testing demonstrated comparable mechanical strength to the predicate devices." However, it does not provide specifics about what that testing entailed, any quantitative acceptance criteria for mechanical strength, or the results of that testing.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study effect size.
- Standalone performance study details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This information is typically found in detailed testing reports, clinical study summaries, or engineering verification and validation documents, which are not included in this 510(k) summary. The 510(k) summary is designed to demonstrate substantial equivalence, not to provide a full report of all testing and acceptance criteria.
§ 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.