(82 days)
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The proposed sling is a sterile, single use device, consisting of a synthetic mesh sling assembly and packaged with a delivery device. The mesh assembly consists of a knitted polypropylene monofilament fiber mesh body implant, dilators, mesh sleeve and center tab.
The provided text describes a 510(k) submission for a surgical mesh, the Advantage™ System, Advantage™ Fit, and Lynx™ System. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than clinical studies or acceptance criteria for a new, novel device with specific performance metrics defined by a study.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, and detailed study methods for proving device performance (like sample sizes for test/training sets, expert involvement, and MRMC studies) is not directly addressed in this type of submission.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance:
The document states that material and bench testing were done to demonstrate that the device meets performance specifications, but it does not explicitly list the acceptance criteria or specific reported performance values in a table. It generally concludes that the device "meets the predetermine specifications and is acceptable for clinical use."
| Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|
| Material properties suitable for intended use | Material testing performed, results demonstrate suitability. |
| Device manufactured meets performance specifications | Bench testing performed, results demonstrate specifications are met. |
| Biocompatible for intended use | Biocompatibility testing performed in accordance with EN ISO 10993-1, results demonstrate biocompatibility. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. The testing is described as "Non-Clinical Testing" (material testing, bench testing, biocompatibility testing), implying laboratory or in-vitro settings, not human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the non-clinical testing described. "Ground truth" in this context typically refers to clinical diagnosis or outcome, which is not the subject of material, bench, or biocompatibility testing.
4. Adjudication method for the test set:
This information is not applicable to the non-clinical testing described. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple experts.
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:
This information is not applicable. An MRMC study is a clinical study format. The submission describes non-clinical testing for substantial equivalence, not a comparative effectiveness study involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical surgical mesh, not an algorithm or AI system.
7. The type of ground truth used:
This is not applicable in the traditional sense of clinical "ground truth." For material, bench, and biocompatibility testing, the "truth" is established by adherence to predefined engineering specifications, material standards, and biocompatibility protocols (e.g., EN ISO 10993-1).
8. The sample size for the training set:
This information is not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established:
This information is not applicable. There is no "training set" as this is not a machine learning or AI device.
In summary:
This 510(k) submission primarily relies on non-clinical testing (material, bench, and biocompatibility testing) to demonstrate substantial equivalence to predicate devices for a surgical mesh. The purpose is to show that the device's physical properties, performance in lab settings, and safety (biocompatibility) are comparable to already approved devices. It does not involve clinical studies with human subjects, AI algorithms, or the detailed expert-driven ground truth establishment typically required for such studies. The document states that the testing demonstrated the device met "predetermine specifications," but specific numerical acceptance criteria and results are not detailed in the provided excerpt.
§ 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.