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4DDome® is a semi-resorbable surgical plug and mesh for abdominal reinforcement, including open surgical repair and reinforcement of iguinal and crural hernias.

The 4DDOME® device is composed of a dome and onlay patch. The dome is made of 10 % light polypropylene and 90 % resorbable Poly-L-Lactide (PLLA). The dimensional stability of the dome combined with the physiological absorption of the PLLA ensure that the hernia sac is kept in place and the transversalis fascia is strengthened due to the PLLA generating cellular fibrosis.

The 4DDOME® medical device is composed of two prosthesis:

• . one semi-resorbable dome
• one semi-resorbable onlay patch .

The dome is the architectural structure with the best resistance to pressure. It keeps the hernia sac in the preperitoneal space behind the transversalis fascia by supporting itself on the sides of the defected area, where it is fixed with non-resorbable threads.

The provided text describes a medical device, the 4DDome®, and its 510(k) summary for clearance. However, this document does not contain information about acceptance criteria, a study proving device performance against such criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document is a premarket notification for a Polymeric Surgical Mesh (Product Code: FTL) intended for abdominal reinforcement, specifically for open surgical repair and reinforcement of inguinal and crural hernias. It focuses on demonstrating substantial equivalence to predicate devices (WL Gore - Bio-Absorbable® Hernia plug - K033671, Bard - Perfix® plug mesh - K922916, and Atrium - Atrium® self forming plug - K930669).

The key information provided includes:

• Device Description: The 4DDome® is composed of a dome and an onlay patch. The dome is made of 10% light polypropylene and 90% resorbable Poly-L-Lactide (PLLA). The onlay patch is 75% PLLA monofilament and 25% polypropylene monofilament.
• Physical Properties: Tables detailing the material composition, weight, macropores percentage, and thickness for different sizes of the dome and the onlay patch are included.
• Intended Use: Abdominal reinforcement, including open surgical repair and reinforcement of inguinal and crural hernias.
• Contraindications: Allergy to components, septic environment, pregnancy, growing children.
• Substantial Equivalence: The document asserts that there are no significant differences affecting the safety or effectiveness compared to the predicate devices.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as this information is not present in the provided 510(k) summary. The 510(k) process for this type of device typically relies on demonstrating substantial equivalence to already marketed devices through technical characteristics, material properties, and intended use, rather than a clinical study with performance metrics against acceptance criteria like an AI/software device would.

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