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The system is intended for fixation of fractures, malunions and osteotomies involving the distal radius.

The Modified Distal Radius Plating System consists of Titanium alloy Extra Narrow and Extra Long family of plates utilizing non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr for bone fixation and the management of fractures and reconstructive surgeries.

The provided text describes a 510(k) submission for a Modified Distal Radius Plating System and focuses on demonstrating substantial equivalence to predicate devices, rather than a study demonstrating the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or reader improvement.

Therefore, many of the requested elements for describing an AI/CAD-based study are not applicable to this document. The document primarily outlines pre-clinical mechanical testing to ensure the new device is comparable to existing ones.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "pre-clinical data including axial load construct testing, 4-point bending testing, evaluation of galvanic corrosion potential and multidirectional screw capability" demonstrated substantial equivalence. Specific quantitative acceptance criteria (e.g., minimum load bearing, maximum corrosion rate) and the exact quantitative results are not provided in this summary.

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

• Sample Size: Not applicable. The "test set" here refers to the physical devices undergoing mechanical and material testing, not a dataset of medical images or patient records. The number of physical implants/constructs tested is not specified in the provided summary.
• Data Provenance: Not applicable in the context of clinical/imaging data. The data provenance relates to laboratory testing of device components.

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

• Not applicable. Ground truth in this context would be defined by engineering specifications and physical measurements, not expert consensus on medical images.

4. Adjudication method for the test set

• Not applicable. This concept is relevant for expert review of clinical data, not for material and mechanical testing.

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, an MRMC comparative effectiveness study was not done. This document pertains to a medical device's physical and material properties, not an AI/CAD system for image interpretation.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used

• The "ground truth" for this device's performance would be derived from engineering specifications, material science standards, and mechanical testing protocols. For example, the load at which a construct fails in axial loading would be the measurable "truth" compared against a specified acceptance load.

8. The sample size for the training set

• Not applicable. This product is a physical implant, not an AI model requiring a training set.

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

• Not applicable. No training set for an AI model.

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