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The Titanium Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion). The process of tibiotalocalcaneal arthrodesis using an intramedullary nail usually involves an ankle arthrotomy, preparation of the joint surfaces, and then placement of the nail through a plantar incision. Screws are placed proximally into the tibia in a standard fashion and, after compression, the nail can be locked distally with screws into the calcaneus and the talus.

The indications for tibiotalocalcaneal arthrodesis include:

1. Avascular necrosis of the talus
2. Failed total ankle arthroplasty
3. Trauma (malunited tibial pilon fracture)
4. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
5. Revision ankle arthrodesis
6. Neuroarthropathy
7. Rheumatoid arthritis
8. Osteoarthritis
9. Pseudoarthrosis

Intramedullary rods made of titanium alloy are used for the same indications as stainless steel intramedullary rods that have been commercially available continually since the 1950s. These devices are to be implanted by insertion into the long bones for fixation of fractures, or the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, or arthrodesis. Transverse screws can be used to further stabilize bone fragments distally and proximally, as needed. A wide variety of titanium intramedullary nails indicated for used in long bones (femur, tibia, fibula, humerus, radius, and ulna were cleared for commercial distribution in Biomet 510(k) premarket notification (K982953).
These ankle arthrodesis nails have the same general intended use (arthrodesis, internal fixation of bone), warnings and precautions as those nails previously cleared in K982953. The standard arthrodesis nails are10, 11, and 12 mm in diameter in 15 mm and 18 cm lengths. Longer lengths will be made upon request (up to 46 cm length). The longer nails will be used to treat patients who may require revision of a previously implanted arthrodesis nail due to tibial fracture. Substantially similar titanium femoral and tibial nails in 8, 9, 10, 11, 12, 13 and 14 mm diameters up to 46 cm in length were previously cleared in K982953.

This device utilizes standard technology that is commonly known by physicians. This technology has been used in commercially available metallic internal fixation devices prior to May 28, 1976. This particular device is a tubular metal rod that is inserted through the talus and into the medullary canal of the tibia to stabilize bone fragments until healing has occurred.

The provided text is a 510(k) premarket notification for a medical device (Titanium Ankle Arthrodesis Nail). It establishes substantial equivalence to a predicate device and outlines the intended use and indications for use. However, it does not include information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance testing documentation.

Medical devices like this intramedullary nail typically demonstrate "acceptance criteria" through various engineering and biocompatibility tests, and often through clinical literature references rather than a single, specific study detailed in a 510(k) summary. The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device.

Therefore, many of the requested fields cannot be directly answered from the provided document.

Here's an attempt to answer based on the available information and general knowledge of 510(k) submissions for similar devices, noting where information is explicitly not present:

1. A table of acceptance criteria and the reported device performance

• Mechanical Properties: Tensile strength, yield strength, fatigue life, torsional strength (meeting ISO standards or equivalent for implantable metals).
• Biocompatibility: Absence of cytotoxicity, sensitization, irritation, genotoxicity, etc., as per ISO 10993 standards.
• Sterility: Demonstrated sterility assurance level (SAL).
• Corrosion Resistance: Meeting standards for implantable titanium alloy.
• Dimensional Accuracy: Conformance to design specifications. | The document states that the device is "substantially equivalent" to predicate devices (Biomet Titanium Intramedullary Nails previously cleared in K982953) and uses "standard technology that is commonly known by physicians." This implies that the device meets the performance and safety profiles of these predicate devices based on the inherent properties of titanium alloy and the established design of intramedullary nails. Specific quantitative performance data is not provided in this summary. |

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable/not provided. This document does not describe a clinical performance study with a distinct "test set" of patients. The substantial equivalence relies on comparison to a predicate device and the known properties of the materials and design.
• Data Provenance: Not applicable/not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/not provided. No clinical "test set" requiring ground truth establishment is described.

4. Adjudication method for the test set

• Not applicable/not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a surgical implant (orthopedic nail), not an AI-powered diagnostic or assistive tool. MRMC studies are for evaluating diagnostic image interpretation by human readers, often with and without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. The "truth" here is established primarily through engineering testing against recognized standards for medical implants and clinical history of similar predicate devices. Outcomes data for a general class of devices (intramedullary nails) in orthopedic surgery would support their effectiveness, but a specific "ground truth" for this device in a study is not mentioned.

8. The sample size for the training set

• Not applicable/not provided. A "training set" is relevant for machine learning algorithms, which this device is not.

9. How the ground truth for the training set was established

• Not applicable/not provided.

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