(1139 days)
TisuthesTM e-PTFE Surgical Patches are intended for facial plastic and reconstructive surgery.
Tisuthes™ e-PTFE Surgical Patches are intended for facial plastic and reconstruction surgery. The device is provided sterile. The device is available in the forms of sheets, blocks and preformed three-dimensional forms (chin, nasal, temporal piriform and malar) with multiple sizes.
The provided FDA 510(k) summary (K201153) describes a medical device, the Tisuthes™ e-PTFE Surgical Patch, and aims to demonstrate its substantial equivalence to predicate devices. However, this document does not contain the kind of detailed performance study information requested in your prompt regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, or adjudication methods.
This 510(k) submission primarily focuses on comparing the proposed device's characteristics (indications for use, materials, design, shapes, physical dimensions, pore size, sterilization) with those of legally marketed predicate devices. The "Non-Clinical Tests Performed" section lists various ISO and ASTM standards, which are general biocompatibility and material testing standards, not performance studies as typically understood in the context of AI/medical image analysis or diagnostic devices.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving the device meets them based on the provided text. The document states that the proposed device is "determined to be Substantially Equivalent (SE) to the predicate devices" based on similar classification information, specifications, and performance effectiveness, but it does not provide the underlying data or studies to support this "performance effectiveness" claim in the detailed format you've requested.
Here's why the information is missing:
- Type of Device: The Tisuthes™ e-PTFE Surgical Patch is a physical implant (surgical mesh). The requested criteria (e.g., accuracy, sensitivity, specificity, MRMC studies) are typically relevant for diagnostic devices, AI algorithms, or imaging systems, not for physical implants like surgical patches.
- Regulatory Pathway: A 510(k) submission demonstrates "substantial equivalence" to a predicate device, meaning it is as safe and effective as a legally marketed device. This often relies on comparative data for material properties, biocompatibility, and intended use, rather than a de novo clinical trial with defined acceptance criteria for a new diagnostic performance metric.
- Focus of the Document: The document's purpose is to satisfy the 510(k) requirements by showing how the new device is substantially equivalent to existing ones. It does not present new efficacy or performance study data in the way a PMA (Premarket Approval) submission or an AI/diagnostic device submission might.
In summary, the provided text does not contain the information needed to create the table and answer the questions about acceptance criteria, study design, expert involvement, and ground truth establishment for a performance study.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.