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The r3 Tibial Implants of the Kinos Total Ankle System are indicated for revision total ankle arthroplasty. The Kinos Total Ankle System is intended for cement use only.

The subject line extension to the Kinos Total Ankle System are implant and instrument components designed to preserve motion in patients with ankle arthritis or previously failed ankle surgery. The device is a fixed bearing and semi-constrained implant construct, intended for replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury. The subject device provides limited mobility to a patient by restoring alignment of the articulating surfaces, reducing pain, and providing flexion-extension movement within the ankle joint. The tibial and talar implants are intended to be used with bone cement. The subject Kinos Total Ankle System consists of three implant components - a tibial implant affixed to the tibia, a bearing implant assembled to the tibial implant and a talar implant affixed to the talus. The tibial implant and bearing implant, assembled intraoperatively, function together and articulate with the talar implant to create a fixed bearing prosthesis, replacing the articulating surface of the tibiotalar joint. The extension includes tibial segments which are assembled intraoperatively to the tibial base plate to enhance tibial fixation height in the tibia.

The provided document is an FDA 510(k) clearance letter for the Kinos Total Ankle System. This document focuses on the substantial equivalence of a new device (a line extension) to a previously cleared predicate device, rather than the performance of an AI/ML device.

Therefore, the information required to answer the prompt (acceptance criteria, study details for AI/ML device performance, sample sizes, expert involvement, ground truth, etc.) is not present in this document.

The document details the device's classification, indications for use, and a summary of performance testing primarily related to mechanical properties of the implant (e.g., fatigue testing, bone stability, assembly tests, porous surface characterization). This is typical for a medical device clearance that is a physical implant, not a software or AI/ML diagnostic tool.

In summary, this document does not contain the information requested in your prompt regarding AI/ML device acceptance criteria and performance study details.

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The Arthrex DualCompression Hindfoot Fusion Nail Implant System is intended to facilitate tibiotalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after turnor resection. These include neuroosteoarthropathy (Charcot's Foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, osteoarthritis, rheumatoid arthritis, and pseudoarthrosis.

The Arthrex DualCompression Hindfoot Fusion Nail Implant System is comprised of the Arthrex DualCompression Hindfoot Fusion Nails, Interlocking Screws, Cable and End Caps. The Arthrex DualCompression Hindfoot Nail is available in 10.5, 11.5 and 12.5 mm diameters and lengths of 180, 210, 240 and 300 mm. The Interlocking Screws are fully threaded, headed or headless, self-tapping, solid, low profile screws. The screw family is 5.0 mm in diameter and ranges from 20 mm to 120 mm in length (in 2 or 5 mm increments). The End Caps are designed to prevent bone in growth in the distal portion of the Nail implant for ease of removal. The end cap family ranges from 1 to 11 mm in length for various countersinking depths.

The Arthrex DualCompression Hindfoot Fusion Nails are manufactured from Titanium Alloy (Ti-6AL-4V conforming to ASTM F136), Superelastic Nitinol (conforming to ASTM F2063) and Polyetheretherketone (PEEK)(conforming to ASTM F2026). The Arthrex DualCompression Hindfoot Nail is sold sterile and is single-use. The Interlocking Screws and End Caps are manufactured from Titanium Alloy (Ti-6AL-4V conforming to ASTM F136). The Interlocking Screws and End Caps are sold non-sterile and are single-use.

This is a 510(k) summary for a medical device called the "Arthrex DualCompression Hindfoot Fusion Nail Implant System." It is not a study that demonstrates the performance of an AI/ML powered device. Therefore, I cannot provide the detailed information requested regarding acceptance criteria, study design, and ground truth establishment for such a device.

However, I can extract information related to the performance data and the comparison made for this specific device in its 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a traditional 510(k) for a hardware implant, the "acceptance criteria" are based on demonstrating substantial equivalence to existing predicate devices. Performance is assessed through mechanical and biocompatibility testing, not through clinical accuracy metrics for AI. The table below summarizes the types of tests performed and the general conclusion regarding equivalence. Specific numerical acceptance criteria values are not provided in this summary, but the conclusion states that the device performs "equivalent to the predicate devices" or meets "pyrogen limit specifications."

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

• Test Set (for mechanical & physical testing): The document does not specify the exact number of samples (test articles) used for each mechanical, material, or biocompatibility test. It only states that "testing was conducted."
• Data Provenance: The tests are laboratory-based and conducted in accordance with recognized ASTM and ISO standards. The data provenance is these standardized laboratory test environments. It is not patient data.

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

This information is not applicable. For a hardware implant, "ground truth" typically refers to established physical properties and biological responses, measured in a laboratory setting or specified by standards. It does not involve expert interpretation of medical images or clinical outcomes in the same way an AI device would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable for the type of testing described (mechanical, material, biocompatibility). Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies, particularly for AI devices where human expert consensus is needed.

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:

This is not applicable. No MRMC comparative effectiveness study was performed as this is a hardware implant, not an AI-powered diagnostic or assistive tool.

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

This is not applicable as the device is a physical implant, not an algorithm.

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

The "ground truth" for this device's evaluation is primarily established by:

• Standardized Test Methods: Adherence to established ASTM and ISO standards (e.g., for mechanical properties, biocompatibility, and MRI safety).
• Engineering Analyses: Internal analyses by Arthrex to conclude acceptability of certain parameters (e.g., torque values).
• Predicate Device Performance: The underlying assumption that if the new device performs equivalently to previously cleared predicate devices in these tests, it is safe and effective.

8. The sample size for the training set:

This is not applicable. The device is a physical implant, not a machine learning model that requires a training set.

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

This is not applicable for the same reason mentioned in point 8.

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