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The Howmedica Leibinger Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients, but is not intended for use in the mandible and/or full load bearing procedures.

The Howmedica Leibinger Resorbable Fixation system consists of a series of plates and mesh in varying configurations and lengths which are attached to the bone using screw fixation. The plates are available in two thicknesses (1.0mm and 1.5mm). The mesh is also available in two thicknesses (0.7mm and 1.2mm). Additionally, there are two screw diameters of 1.5mm and 2.0mm and a third emergency screw with a 2.5mm diameter. These plates and screws are intended for use in the fixation bones of the craniofacial and midfacial skeleton affected by trauma or for The plates and mesh can be contoured by heating. reconstruction. The system can be used in both adult and pediatric patients.

This document describes a 510(k) submission for a medical device and does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.

The provided text pertains to the "Howmedica Leibinger Resorbable Fixation System," a bone plating system. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices (LactoSorb Trauma Plating System and Luhr® Pan Fixation System) rather than outlining specific performance acceptance criteria and a study to meet them.

Here's why the requested information cannot be extracted:

• No Acceptance Criteria or Performance Study: The document is a 510(k) summary, which is a premarket notification to the FDA. It primarily asserts that the new device is "substantially equivalent" to existing legally marketed devices. This typically involves demonstrating similar intended use, technological characteristics, and safety and effectiveness, often through comparison to predicate devices and material testing, rather than a clinical study with defined acceptance criteria for a novel performance metric.
• Focus on Substantial Equivalence: The text explicitly states, "The substantial equivalence of this device is based on similarities in intended use, design and operational principles to the LactoSorb Trauma Plating System (Biomet) and the Luhr® Pan Fixation System (Howmedica)." It also mentions, "Testing was performed to demonstrate an equivalence in performance to the LactoSorb Trauma Plating System (Walter Lorenz subsidiary of Biomet)." This "testing" is for equivalence, not for meeting novel performance criteria specific to this device against a predefined benchmark.
• Lack of Clinical Study Details: There are no details about a clinical trial, patient populations, outcome measures, statistical analysis, or comparison to a ground truth, which would be necessary to describe a study proving acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided 510(k) summary.

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