(268 days)
The Medlinx Surgical Mesh is intended to be implanted to reinforce soft tissue where weakness exists for the repair of hernias and other abdominal fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
The Medlinx Surgical Mesh is a sterile, implantable, single-layer polymeric mesh that is comprised of non-absorbable polyvinylidene fluoride (PVDF) and absorbable poly(1,4-butylene adipate) (PBA). The PBA plasticizer increases the flexibility of the mesh, and it is partially absorbed once implanted.
The provided text describes a 510(k) Premarket Notification for the "Medlinx Surgical Mesh." This document focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria for performance in a clinical study with an AI device.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI device is not applicable to this document.
However, I can extract information related to the device's characteristics and the types of testing conducted to support its substantial equivalence.
Here's a breakdown of what can be inferred from the provided text, addressing your questions where applicable, and stating "Not Applicable" or "Not Provided" when the information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a traditional medical device (surgical mesh), not an AI device, there are no "acceptance criteria" in the sense of predictive performance metrics (like sensitivity, specificity, AUC) against a ground truth. Instead, the "performance" relates to its material characteristics and biological interactions compared to predicate devices.
| Performance Metric Area | Reported Medlinx Surgical Mesh Performance |
|---|---|
| Biocompatibility | "The biocompatibility testing showed the comparable safety profile of the Medlinx Surgical Mesh and the predicates." (Tests included: In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, In Vitro Bacterial Reverse Mutation (AMES), In Vitro Chromosome Aberration, In Vitro Mammalian Cell Gene Mutation, Intramuscular Implantation, In Vitro Hemolysis, Pyrogenicity, Sub-Chronic Systemic Toxicity) |
| Bench Testing | "Bench testing demonstrated that the device is substantially equivalent for the repair of hernias or other abdominal fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result." (Tests included: Mesh Density, Tensile Strength, Device Stiffness, Suture Pullout Strength, Burst Strength, Tear Resistance, Residual levels of heavy metals, Polymer purity, Biodegradation, PBA Extraction, Expiration Dating) Specific numerical acceptance criteria and direct performance values (e.g., "Tensile Strength > X MPa") are not provided in this summary, only the conclusion of substantial equivalence. |
| Animal Testing | Implied similarity to predicates based on the guidance followed, but no specific performance metrics or outcomes are directly stated. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. This is not an AI device evaluated on a clinical test set. The "testing" involved laboratory bench tests, in vitro tests, and animal studies. Specific sample sizes for these tests are not provided in this summary.
- Data Provenance: Not applicable. The tests are laboratory-based and animal studies, not human clinical data with provenance like country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is a traditional medical device. "Ground truth" in the context of expert consensus for AI model evaluation is not relevant here. The "truth" for these tests comes from established scientific and engineering principles (e.g., measuring tensile strength, observing cellular reactions).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication for a test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the AI context. For this medical device, the "truth" is established through:
- Biocompatibility Standards: Compliance with established biological safety guidelines (e.g., ISO 10993 series, implicitly followed as per the guidance document).
- Engineering Standards: Measurement against defined physical and mechanical properties (e.g., tensile strength, burst strength as per ASTM or similar standards, implicitly followed).
- Animal Models: Observations in animal studies to assess in vivo response to implantation.
8. The sample size for the training set
- Not applicable. This is not an AI device; there is no training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI device; there is no training set.
§ 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.