(33 days)
Optilene Meshes (Standard, Universal, and Elastic) are indicated for hernioplasty and repair of other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Optilene® Mesh is a synthetic implantable sheet for the reinforcement of connective tissue structures. It consists of monofilament polypropylene, which is knitted into a dimensionally stable, thin, and flexible net that is cut into various sizes and shapes.
The provided text is a 510(k) summary for the Optilene® Mesh Line Extension. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria, as typically requested for AI/ML-based medical devices.
The document primarily focuses on establishing substantial equivalence based on technological characteristics and bench testing. It does not provide performance metrics like sensitivity, specificity, or reader improvement for a human-in-the-loop scenario.
Here's a breakdown of the requested information based on the provided text, highlighting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Not present in the document.
The document states that "Sufficient bench testing was conducted in accordance with the FDA guidance document 'Guidance for the Preparation of a Premarket Notification for a Surgical Mesh' to show that Aesculap's Optilene® Meshes are comparable to the predicate surgical mesh." However, it does not detail specific acceptance criteria (e.g., tensile strength, pore size, biocompatibility metrics) or the quantitative results from these bench tests.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for this type of device.
This information is typically relevant for studies involving data analysis, such as imaging or diagnostic devices. For a surgical mesh, the "test set" would refer to the materials used in bench testing. The document does not specify the sample size of meshes or materials used for the bench tests, nor does it provide details on the provenance of such materials (e.g., country of origin).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable for this type of device.
This concept is for devices where human experts interpret data to establish a ground truth (e.g., radiologists labeling images). For a surgical mesh, ground truth is established through physical properties testing, not expert interpretation of data relevant to a "test set" of cases.
4. Adjudication Method for the Test Set
Not applicable for this type of device.
Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among experts when establishing ground truth from data. This is not relevant to the bench testing of a surgical mesh.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done.
MRMC studies are typically performed for diagnostic devices where human readers interpret medical cases. This device is a surgical mesh, which does not involve human readers interpreting cases in the context of device performance. The document does not mention any human reader involvement in evaluating the mesh's effectiveness.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable in the context of AI/ML algorithms.
This device is a physical surgical mesh, not an algorithm. The performance of the mesh is evaluated through bench testing of its physical and mechanical properties, not through an algorithm's standalone performance.
7. The Type of Ground Truth Used
For the Optilene® Mesh, the "ground truth" for demonstrating substantial equivalence is based on:
- Technological Characteristics: Comparison of material (monofilament polypropylene), structure (knitted, dimensionally stable, thin, flexible net), and forms (various sizes and shapes) to the predicate device.
- Bench Testing Results: The document states that "Sufficient bench testing was conducted... to show that Aesculap's Optilene® Meshes are comparable to the predicate surgical mesh." This implies that the ground truth for "comparability" would be established by measuring various physical and mechanical properties (e.g., tensile strength, burst strength, pore size, material composition) and confirming they fall within acceptable ranges or are similar to the predicate device. The specific methods and criteria for this "comparability" are not detailed.
8. The Sample Size for the Training Set
Not applicable for this type of device.
A training set is relevant for AI/ML algorithms that learn from data. This device is a physical surgical mesh.
9. How the Ground Truth for the Training Set Was Established
Not applicable for this type of device.
As above, this concept pertains to AI/ML devices.
§ 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.