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Indicated for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to remove malignant or benign tumors requiring the removal of the mandibular condyle. This device is not intended for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). Implants are intended for single patient use.

The OsteoMed Temporary Condylar Attachment system is a solid condylar head which attaches with fastening screws to an OsteoMed Fracture Reconstruction Plate. The OsteoMed Temporary Condylar Attachment is available for right and left placement. System instruments include drivers.

This 510(k) submission document for the OsteoMed Temporary Condylar Attachment System does not contain information regarding an acceptance criteria table or a study proving the device meets acceptance criteria.

The document provided is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than presenting new performance data or clinical study results to establish de novo acceptance criteria.

Here's what can be inferred from the document regarding the device's assessment:

• Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The submission relies on substantial equivalence to predicate devices.
• Study That Proves the Device Meets Acceptance Criteria: This information is not provided in the document.

Explanation Based on the Document Content:

The core of this 510(k) submission is the claim of "substantial equivalence" to predicate devices. The document states:

"Equivalence for this device is based on similarities in intended use, material, design and operational principle to the KLS-Martin Temporary Condylar Implant (K990667), the W. Lorenz Add-On Condyle (K002790), and the Stryker Leibinger Locking Screw Mandibular Reconstruction Plate (K000594)."

"Due to the similarity of materials and design to predicate devices, OsteoMed believes that the OsteoMed Temporary Condylar Attachment System does not raise any new safety or effectiveness issues."

This indicates that instead of conducting a new study to establish performance against specific acceptance criteria, OsteoMed is asserting that its device is safe and effective because it is similar to already legally marketed devices that have been deemed safe and effective. Therefore, a clinical study demonstrating performance against specific acceptance criteria, as typically seen for novel devices or those requiring a PMA (Pre-Market Approval), is not present in this 510(k) summary.

In summary, based only on the provided text, none of the requested information (acceptance criteria table, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) can be extracted because the submission relies on substantial equivalence rather than new performance data.

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