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The DARCO® Locking Bone Plate System is intended for use in stabilization of fresh fractures, joint fusion, and reconstruction of small bones of the feet, ankles and toes. The system can be used in both adult and pediativ patients.

The DARCO® Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different curvatures, material strengths, number of plate holes and through different grades or bridge widths.

This document is a 510(k) premarket notification for the DARCO® Locking Bone Plate System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for device performance. Therefore, many of the requested details, particularly those related to a clinical study (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance), are not available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical performance metrics for the device. Instead, it relies on demonstrating substantial equivalence in technological characteristics and performance to a predicate device.

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

Not applicable. This document describes a submission for a medical device that relies on substantial equivalence to a predicate device based on mechanical testing and design comparison, not a clinical study with a "test set" of patient data.

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

Not applicable. No ground truth based on expert review of a test set is mentioned.

4. Adjudication method for the test set

Not applicable. No adjudication method is described as there is no test set of clinical data.

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 document describes a physical medical device (bone plate system), not an AI-assisted diagnostic tool.

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

Not applicable. This document describes a physical medical device, not an algorithm.

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

The document does not describe the use of a "ground truth" derived from clinical data in the context of a performance study. For the mechanical testing, the "ground truth" would implicitly be engineering standards and established mechanical properties, benchmarked against the predicate device.

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not a machine learning model requiring a training set.

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

Not applicable. No training set is mentioned.

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