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The Dyna Locking Ankle Nail™ is used in various indications as follows.

• Post-traumatic and degenerative arthritis involving both ankle and subtalar joints
• Rheumatoid arthritis
• Revision of failed ankle arthrodesis with subtalar involvement of with an insufficient talar body
• Revision of failed total ankle arthroplasty with subtalar intrusion .
• Talar deficiency conditions requiring tibiocalcaneal arthrodesis
• Avascular necrosis of the talus
• Neuroarthropathy or neuropathic ankle deformity
• Severe deformity as a result of talipes equionovarus, cerebral vascular accident, paralysis of other neuromuscular disease
• Severe pilon fractures with trauma to the subtalar joint .

The Dyna Locking Ankle Nail™ consists of Ankle Nail, Locking Screw, Set Screw, and End Cap. The Ankle nails are available in variety of diameters and lengths. And End Cap screws into the threaded end of the nail to prevent bone ingrowth. Locking Screw has the self-tap at the end of the screw. All components of the Dyna Locking Ankle Nail™ are single use device, supplied non-sterile, and manufactured from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM 136. Specialized instruments made from surgical instrument grade stainless steel are available for the instrumentation and removal of the Dyna Locking Ankle Nail™.

The provided document is a 510(k) summary for the "Dyna Locking Ankle Nail™," which is an intramedullary fixation system. This type of device is a physical implant used in orthopedic surgery, not an AI/ML-based device. Therefore, the questions related to AI/ML performance metrics, such as accuracy, F1 score, expert ground truth, effect size with AI assistance, and training/test set sample sizes for algorithms, are not applicable.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical performance testing conducted to demonstrate substantial equivalence to predicate devices.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact number of nails or samples tested for each type of bench test (static 4-point bend, static torsion, dynamic 4-point bend). It only indicates that "The Dyna Locking Ankle Nail™ was tested in a non clinical setting (bench testing)."
• Data Provenance: The testing was "non clinical setting (bench testing)," meaning it was conducted in a laboratory environment, not using human or animal subjects. The location of the testing laboratory is not explicitly stated, but the manufacturer is based in South Korea. The data is prospective in the sense that these tests were performed specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable. For a mechanical device like an intramedullary nail, "ground truth" is established by engineering standards and specifications (e.g., ASTM standards or internal design requirements for bending and torsion strength/fatigue). There is no "expert consensus" on images or clinical data for this type of submission.

4. Adjudication Method (for the test set)

This question is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or for establishing ground truth from multiple expert opinions. For bench testing, results are quantitative and directly measured against pre-defined performance specifications.

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 question is not applicable, as the device is a physical intramedullary fixation system, not an AI/ML diagnostic or assistive tool.

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

This question is not applicable, as the device is a physical intramedullary fixation system, not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" here refers to the engineering specifications and performance criteria that the device's mechanical tests needed to meet to demonstrate substantial equivalence to predicate devices. While not explicitly stated as "ground truth," these are the objective standards against which the test results were compared.

8. The Sample Size for the Training Set

This question is not applicable, as there is no "training set" for a mechanical device undergoing bench testing.

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

This question is not applicable for the reasons mentioned above.

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