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The Correx Software is intended to be used as a component of multilateral external fixation system for the Vilex External Fixation System with the indications listed below:

• Stabilization of Fractures & Osteotomy
• Rear and Mid-foot Arthrodesis
• Adult and Pediatric Leg Lengthening
• Correction of Bone Deformity in Upper & Lower Extremities

The Correx Software, intended for use with the Dynex Ring Fixation System (K202054), is an optional-use computational environment that can be used for determining the orientation of bone segments and external fixator elements attached to a bone to treat fractures and bone deformities.

The software includes user interface, processing, data storage, and display functions. The Correx Software can be used to visualize the position of a moving bone segment and to compute the strut lengths necessary to implement any desired translation or rotation. The Software program does not control the device. The Software program does not control any hardware (such as rings, struts, wires) directly. The goal of the Software program is to provide the Surgeon with a tool for determining the length of the six struts connecting the two circular rings. The Surgeon must decide where a bone segment should line up and the angulation and translation necessary for the treatment. The magnitude and direction of any rotation or translation is ultimately the responsibility of the Surgeon.

The provided text describes the Correx Software (K212552), intended for use with the Vilex External Fixation System. However, it does not contain specific acceptance criteria or reported device performance metrics in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing comprehensive performance studies with acceptance criteria and statistical results.

Here's a breakdown of what can be extracted or inferred based on the provided text, and what is missing:

The 510(k) summary states:

"Software verification and validation testing was undertaken to ensure that the product requirements and specifications were met."

This indicates that internal testing was performed, but the details of this testing (acceptance criteria, specific performance metrics, study design, sample sizes, etc.) are not provided in this public document.

Missing Information:

• A table of acceptance criteria and the reported device performance: This is the primary missing piece. The document merely confirms that "Software verification and validation testing was undertaken."
• Sample sizes used for the test set and the data provenance: Not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
• Adjudication method for the test set: Not provided.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned. The focus is on the software's ability to compute strut lengths, not on human reader performance with or without AI assistance.
• If a standalone study was done: The description implies standalone testing as it focuses on software verification and validation, but specific study details are absent.
• The type of ground truth used: Not specified.
• The sample size for the training set: Not specified, as this appears to be a software tool for calculation/visualization, not an AI/ML model that typically requires a large training set in the conventional sense.
• How the ground truth for the training set was established: Not specified.

What can be inferred from the document:

• Device Function: The Correx Software is an "optional-use computational environment" that helps determine the orientation of bone segments and external fixator elements, and computes strut lengths. It takes "Surgeon Inputs based on X-Ray positioning" as input and outputs a "Daily schedule of strut lengths."
• Intended Use: As a component of a multilateral external fixation system for specific orthopedic indications (fractures, osteotomy, arthrodesis, leg lengthening, deformity correction).
• Comparison to Predicate: The document claims "The subject and predicate device share the same intended use and technological characteristics." This implies that the performance expectations would be similar to the predicate (X-Fix Line Additions, K151881), which is also software for diagnosis/treatment in external fixation.

Conclusion based on the provided text:

The provided 510(k) summary for Correx Software (K212552) indicates that verification and validation testing was performed to meet product requirements. However, it does not include the specific details of acceptance criteria, reported performance, study designs, sample sizes, or ground truth establishment that would typically be found in a detailed study report. The document's purpose is a regulatory submission for substantial equivalence, not a publication of a detailed performance study.

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