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The Arthrex DynaNite K-Wire is indicated for fixation of osteotomies and reconstruction of the lesser toes following correction procedure for hammertoe.

The Arthrex DynaNite K-Wire is a double tipped, unthreaded implantable Nickel Titanium (Nitinol) K-Wire consisting of two regions: a longer, superelastic end and a shorter, malleable end to allow fixation of bone fragments while being able to deform the protruding end. The Arthrex DynaNite K-Wire family ranges from 0.86 mm to 2.5 mm in diameter and is 5.91 inches in length. The Arthrex DynaNite K-Wire is sold sterile and is single-use.

This document, K200068, is a 510(k) premarket notification for the Arthrex DynaNite K-Wire. It's important to understand that a 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than providing the detailed clinical trial data and acceptance criteria typically associated with de novo classifications or PMA applications for novel devices or high-risk devices.

Therefore, the document describes engineering and biocompatibility testing to demonstrate performance and safety, not an AI model that requires a "study that proves the device meets acceptance criteria" in terms of performance metrics like sensitivity, specificity, or human reader improvement.

Based on the provided text, here's what can be extracted and how it differs from a typical AI/software as a medical device (SaMD) study:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" here are based on meeting performance requirements comparable to the predicate device and established standards for metallic bone fixation fasteners, and ensuring biocompatibility.

2. Sample Size Used for the Test Set and Data Provenance:

• For the mechanical tests related to performance (tensile, bend, fatigue), the sample sizes are not explicitly stated but would be the number of test articles (K-wires) subjected to each specific test. These are in-vitro (lab-based) tests, not human data.
• For biocompatibility tests, sample sizes are implied to be sufficient for the specific biological tests (e.g., cell cultures for cytotoxicity, animal models for implantation/systemic toxicity, or specific chemical analyses). These are also in-vitro or in-vivo (animal model) tests, not human data.
• Data Provenance: The data comes from the manufacturer's internal testing as part of their design verification and validation process, conducted according to recognized ASTM and ISO standards. It is prospective in the sense that the tests were specifically performed for this submission, using newly manufactured devices. It is not patient data from a specific country.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This section is not applicable to this type of device and submission. "Ground truth" in the context of an AI/SaMD diagnostic device typically refers to clinical diagnosis or pathology verified by multiple expert readers. For a medical device like a K-wire, "ground truth" is established by adherence to engineering standards, material science principles, and biocompatibility guidelines. The "experts" are the engineers, material scientists, and toxicologists who conducted and interpreted these tests.

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical trial data involving image interpretation or clinical outcomes where there might be inter-reader variability. For engineering and biocompatibility testing, success or failure is determined by whether the device meets predefined pass/fail criteria for each test according to the relevant standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This is not applicable. MRMC studies are used to evaluate the impact of an AI algorithm on human reader performance for diagnostic tasks. The Arthrex DynaNite K-Wire is a physical implantable device, not a diagnostic AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

This is not applicable. This concept applies to AI algorithms. The K-wire's "performance" is its physical and biological properties.

7. Type of Ground Truth Used:

As explained above, the "ground truth" is defined by:

• Engineering standards: ASTM and ISO specifications for mechanical properties (e.g., required tensile strength, fatigue life).
• Biocompatibility standards: ISO 10993 series and USP for biological safety (e.g., acceptable cytotoxicity limits, pyrogen limits).
• Predicate device performance: The performance of the predicate device (K132895: WMT Implantable K-Wires) serves as a benchmark for demonstrating substantial equivalence for mechanical properties.

8. Sample Size for the Training Set:

This is not applicable. "Training set" refers to data used to train machine learning models. This device does not involve machine learning.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable.

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The Trident Fusion Implant has the following Indications for Use: Fixation of osteotomies and reconstruction of the lesser toes and lesser fingers following correction procedures for hammertoe, claw toe, mallet toe, and other deformities of the feet and hands.

The Vilex Trident Fusion Implant is a single-piece cannulated bone screw intended for the fixation of PIP joints in lesser toes and digits. The device is offered straight or with a 10° bend at the joint. It is available in either stainless steel or titanium.

The provided text is a 510(k) Summary for the Vilex Trident™ Fusion Implant. This document is a premarket notification to the FDA, demonstrating that a new device is as safe and effective as a legally marketed predicate device.

It does not contain information about acceptance criteria, device performance, or human study results. The document focuses on establishing substantial equivalence based on indications for use, material, sizes, shapes, and technological characteristics compared to predicate devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding studies with human participants, expert ground truth, sample sizes, or MRMC studies, as none of this information is present in the provided text.

The closest information to "device performance" is the statement repeated under "Technological Characteristics" and "Substantial Equivalence" that: "The technological characteristics for the Trident Fusion Implant are the same as the characteristics of the predicate devices." and "The design features of the Trident Fusion Implant are substantially equivalent to the design features of other predicate devices previously cleared for market." This implies that its performance is expected to be similar to legally marketed devices.

The document states that "The safety and effectiveness of the Trident Fusion Implant are adequately supported by the substantial equivalence information, material information and analysis data provided within this Premarket Notification." However, the details of this "analysis data" proving safety and effectiveness are not included in the provided text.

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