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The OlecraNail™ Intramedullary Fixation System and accessories are intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic setting.

The OlecraNail™ intramedullary rod is a solid bore, stainless steel, tapered rod that is inserted into a pre-drilled hole into the medullary canal of the proximal ulna. Once the device is in place, a combination stainless steel/polyphenylsulfone guide is used to drill into the bone and insert several screws through the bone and rod to secure all bone fragments and lock the rod into position. During this process, compression at the fracture site may be obtained by manually turning a knob to activate the compression mechanism. After all screws are placed, the guide may then be detached using a break-away mechanism.

The provided text describes a medical device called the OlecraNail™ Intramedullary Fixation System. It focuses on demonstrating the device's substantial equivalence to previously marketed devices and its mechanical performance.

However, the provided text DOES NOT contain information regarding:

• Acceptance criteria in a quantitative sense (e.g., target accuracy, sensitivity, or specificity values).
• Any studies involving patient data, human readers, or clinical outcomes.
• Ground truth establishment for any clinical data.
• Sample sizes for test or training sets related to clinical performance.
• Details about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The "Non-Clinical Tests" section describes mechanical tests performed on the device:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test set sample size: Not specified. The tests were performed on "Olecranail™ intramedullary rods" and "the rod-guide junction." The exact number of units tested is not stated.
• Data provenance: Not applicable. These were non-clinical, mechanical integrity tests performed on the device itself, not on patient data.

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

• Not applicable. These were mechanical tests, not assessments requiring expert interpretation of clinical data.

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

• Not applicable. This is not a clinical study requiring adjudication.

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:

• No. The document describes mechanical tests of a physical orthopedic implant, not an AI-powered diagnostic or assistive device.

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

• No. This device is a physical implant, not an algorithm.

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

• For the mechanical tests, the "ground truth" would be the measured physical properties (elastic limits, rigidity, torsional strength, stress tolerance) as compared against established engineering standards and performance of predicate devices.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no "training set" or corresponding ground truth.

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The OrthoPediatrics Plating System is intended for use in the treatment of pelvic, small and long bone fractures.

The OrthoPediatrics Pediatric Plating system is a system of bone plates and screws to provide the pediatric and general orthopedic surgeon with necessary devices to achieve optimal bone fixation when treating fractures, osteotomies, mal-unions, and mal-alignments.

• Materials: The devices are manufactured from 316L stainless steel, which . meet ASTM F138 and F139, and ISO-5832 standards.
• Eunction: The system functions to provide immediate stability and . temporary fixation during the natural healing process.
  The system includes cortical and cannulated screws, and specialty plates. The specialty plates will include three distinct shapes and each shape will be offered in multiple sizes to accommodate the individual requirements of the patient anatomy to aid the surgeon in achieving optimal fixation. The three specialty plates' shapes resemble the letters H and I, and the infinity symbol (similar to the number 8, lying on its side).

The provided text is related to a 510(k) premarket notification for a medical device (OrthoPediatrics Plating System). It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and indications for use.

Crucially, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (MRMC or standalone AI performance tests). These types of studies and their results are typically required for AI/ML-driven devices to demonstrate their clinical validity and utility.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

The document is a standard 510(k) clearance letter for a traditional medical device (bone plates and screws), where substantial equivalence is typically established through comparisons of material properties, design specifications, and intended use with already marketed devices, rather than through performance metrics of an AI algorithm.

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