Search Results

The KLS-Martin Temporary Condylar Implant is only intended 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 for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).

The KLS-Martin Temporary Condylar Implant is a solid condylar head which attaches with fastening screws to a KLS-Martin Fracture/Reconstruction Plate. The KLS-Martin Temporary Condylar Implant is available for left and right placement.

This 510(k) premarket notification describes a medical device, the KLS-Martin Temporary Condylar Implant, and establishes its substantial equivalence to a predicate device. It does not contain information about a study that assesses the device's performance against specific acceptance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them because such information is not present in the provided text.

The document is a regulatory approval letter and a summary of the device for FDA submission, focusing on:

• Device Identification: KLS-Martin Temporary Condylar Implant.
• Classification: Temporary Condylar Implant.
• Predicate Device: Leibinger Temporary Condylar Implant.
• Intended Use: Temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures for tumor removal.
• Limitations: Not for permanent implantation, TMJ/traumatic injuries, or TMD treatment.
• Substantial Equivalence: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.

There is no mention of specific performance metrics, clinical or non-clinical study design, sample sizes, expert ground truth establishment, or any form of AI performance evaluation.

Ask a specific question about this device