(165 days)
The TiMESH is intended for the reinforcement of tissue during surgical repair. Specifically, the TiMESH is indicated for laparoscopic and open surgery for the repair of direct inguinal hernias, indirect inguinal hernias, femoral hernias, umbilical hernias, incisional hernias, parietal reinforcement of tissues and abdominal wall repair.
TiMESH, also known as TiMESH-TC, hereinafter known as TiMESH/TiMESH-TC" is a non-absorbable polypropylene mesh constructed of warp knitted fabric made from monofilament polypropylene fibers with all around proprietary coating. The TiMESH is constructed using a warp-knit (not woven, not knitted) process. This construction along with the proprietary coating allows the TiMESH to have the strength, flexibility, as well as durability and surgical adaptability to allow for necessary tissue ingrowth. The TiMESH with its current construction provides for elasticity in all directions. The construction of the mesh permits the use of any size mesh without it's unraveling. The wetability allows for the proper adaptation of the mesh to various stresses that can be encountered in the body. The product is stenlized by using ethylene oxide gas.
The document provided describes a 510(k) submission for a surgical mesh, TiMESH/TiMESH-TC. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical trials with defined acceptance criteria and study designs that would typically involve human readers or detailed performance metrics.
Therefore, the provided text does not contain information on acceptance criteria and a study proving the device meets those criteria in the way envisioned by the prompt's request for clinical performance, human-in-the-loop studies, or standalone algorithm performance.
Instead, the submission relies on:
- Substantial Equivalence: Comparing the new device's intended use and technological characteristics to legally marketed predicate devices.
- Biocompatibility: Stating that patient contact materials are common and have a long history of biocompatibility, and that the device complies with AAMI/ANSI/ISO 10993, "Biological Evaluation of Medical Devices."
- Bench Testing: Stating that bench testing was conducted in accordance with the FDA Guidance Document "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."
Because the requested information (acceptance criteria, device performance, sample sizes for test/training sets, expert roles, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies) is not relevant or available in a 510(k) for a surgical mesh of this type, I cannot complete the table or answer the specific questions about clinical performance studies.
A 510(k) for a surgical mesh typically focuses on physical properties, material composition, and biocompatibility, demonstrating that these are equivalent or superior to existing devices. Clinical efficacy and detailed performance metrics as would be found for imaging or diagnostic AI devices are not usually part of such a submission unless there are significant new claims or risks.
§ 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.