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• Intracapsular fractures of the femoral neck
• Intertrochanteric fractures of the femur
• Tibial plateau fractures
• Fractures of the dorsal pelvic ring
• Pelvic sacroiliac joint disruption
• Ankle arthrodesis
• Other indications where cancellous screws are currently used and a guided system may be beneficial

The Dyna Locking Cannulated Screw™ consists of various sizes of cannulated screws and washers. Cannulated screws are designed to be inserted over guide pins and provide several potential benefits over standard screws especially the precision with which they can be placed. Guide pins can be used for provisional fracture fixation, facilitating accurate fracture reduction before definitive fixation with screws. In addition, the guide pins can be placed percutaneously with potential benefits of decreased surgical morbidity. A washer may be used as an extension of the cannulated screw where the cortical bone is soft or thin. All implants of Dyna Locking Cannulated Screw™ are single use device, supplied non-sterile and manufactured from titanium alloy(Ti-6AI-4V ELI) in accordance with ASTM F136. Specialized instruments made from surgical grade stainless steel are available for the instrumentation and removal of the Dyna Locking Cannulated Screw™.

This looks like a 510(k) premarket notification for a medical device called the "Dyna Locking Cannulated Screw™". This document is a submission to the FDA (Food and Drug Administration) to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Let's break down the information to answer your request.

Important Note: The provided document is a 510(k) summary and the FDA's clearance letter. It does not contain information about an AI/ML device, nor does it describe acceptance criteria in the context of AI performance metrics (like sensitivity, specificity, AUC). Instead, it demonstrates substantial equivalence to predicate devices primarily through design, material, and mechanical performance comparison. Therefore, many of your requested points related to AI device evaluation (e.g., ground truth, MRMC study, human-in-the-loop performance, training set) are not applicable to this type of submission.

I will answer the questions based on the information available in the provided 510(k) document, clarifying when a question is not applicable to this type of device.

Description of Acceptance Criteria and the Study that Proves the Device Meets Acceptance Criteria

This 510(k) submission for the "Dyna Locking Cannulated Screw™" is based on demonstrating substantial equivalence to existing predicate devices, rather than meeting specific performance acceptance criteria for an AI algorithm. The "acceptance criteria" here refer to the device's ability to perform mechanically and functionally with similar characteristics to the predicate devices. The study proving this involves engineering analyses of mechanical properties and a comparison of design, materials, and intended use.

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: This is not applicable in the traditional sense for a non-AI/ML mechanical device submission of this nature. The "test set" here refers to the actual physical device for which mechanical tests and comparisons were performed. The document implies samples of the Dyna Locking Cannulated Screw™ were tested or modeled. Specific numbers are not provided in this summary, but typically involve a sufficient number of units to demonstrate reproducibility of mechanical properties.
• Data Provenance: The engineering analyses would have been conducted by the manufacturer, U & I Corporation, located in Kyunggi-Do, Korea. These are likely prospective tests performed on manufactured samples or models of the device to characterize its mechanical properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. For a mechanical fixation device, "ground truth" is established by direct measurement of physical properties and adherence to recognized mechanical standards (e.g., ASTM F136 for materials). Expert radiologists or clinicians are involved in defining the intended use and potentially in clinical evaluation of similar devices, but not in establishing "ground truth" for the mechanical test set itself in this specific context. The engineers performing the tests and comparing specifications serve as the "experts" for this aspect.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in diagnostic or prognostic AI studies. For mechanical testing, the results are typically quantitative and objective measurements (e.g., force required for pull-out, bending moment). Engineering standards and statistical analysis are used to determine if the results meet predefined specifications or are comparable to predicate devices.

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 bone fixation screw; it is not an AI-assisted diagnostic tool or an imaging device involving human readers. Therefore, an MRMC study is irrelevant to this submission.

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

• Not Applicable. This is a physical, mechanical medical device, not an algorithm. There is no "standalone" algorithm performance to evaluate.

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

• The "ground truth" for this device's performance relies on objective mechanical test data (e.g., measurements of pull-out strength, bending strength, torsional strength) and standard material specifications (e.g., ASTM F136 for titanium alloy). The comparison of these properties to those of legally marketed predicate devices forms the basis of the substantial equivalence assertion.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML model, this question is irrelevant to this device submission.

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