Search Results

Mesothelium Dental Membrane is indicated for: simultaneous use of GBR-membrane and implants, augmentation around implants placed in immediate extraction sockets, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

The device is intended for one time use.

Mesothelium Dental Membrane is a barrier membrane for guided tissue and bone regencration in dental applications. It is a resorbable porcine-mesothelium-derived extracellular matrix available as a lyophilized sheet. Mesothelium Dental Membrane is available in a variety of shapes and sizes. Furthermore, the device can be casily trimmed or shaped to the appropriate size to fit the defect to be treated. The device is packaged sterile in a double-layer package.

The provided text describes the regulatory clearance (510(k)) for the "Mesothelium Dental Membrane" and establishes its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/ML device evaluations.

The context of this document is a traditional medical device submission, focusing on material properties, intended use, and comparison to existing predicate devices. It relies on the concept of "substantial equivalence" rather than data-driven performance metrics against predefined acceptance criteria for a novel AI/ML algorithm.

Therefore, for your specific request regarding acceptance criteria and a study demonstrating performance, I must state that the provided text does not contain this information.

Here's why and what's missing:

• Acceptance Criteria & Reported Performance: The document lists "Technological Characteristics" and "Biocompatibility," "Non pyrogenic," and "Resorbable" as properties for comparison. These are characteristics, not quantitative acceptance criteria with numerical performance targets (e.g., sensitivity > X%, specificity > Y%). The "reported device performance" against such criteria is absent.
• Study Details (Sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone): None of these details are present because the submission process described here for a resorbable membrane doesn't involve the kind of performance study typical for an AI/ML diagnostic or assistive device. The "study" here is essentially the comparison table showing similar characteristics and intended use to existing devices, coupled with standard biocompatibility and material testing (which are not detailed in this summary). The ground truth for such a device would be based on established material science and biological response, not expert consensus on image interpretation or clinical outcomes of a diagnostic prediction.
• Training Set: There's no AI/ML algorithm, so there's no training set or ground truth establishment for a training set.

In summary, the provided FDA 510(k) document is for a physical medical device (a resorbable membrane) and relies on demonstrating substantial equivalence to predicate devices based on material properties and intended use. It does not present data, acceptance criteria, or study methodologies that would be relevant to evaluating an AI/ML-based medical device.

Ask a specific question about this device