(434 days)
KIM (Knotless Incontinence Mesh) is a surgical mesh kit for treatment of female stress urinary incontinence resulting from urethral hyper mobility and / or intrinsic sphincter deficiency.
KIM (Knotless Incontinence Mesh) is a sterile, single use surgical mesh kit for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. KIM (Knotless Incontinence Mesh) is composed by a monofilament polypropylene mesh sling and two passers used to pass the sling through the obturator foramens. Polypropylene monofilament traction threads are fixed at each end of the mesh to facilitate the attachment of the passers to the mesh. The passers are used to deliver the sling via the trans-obturator "out-inside" approach. The traction threads are removed after placement of the sling. When placing the mesh, the sling can be adjusted by the surgeon to leave the mesh flat under the urethra, at the proper tension providing extra support to the urethra.
Here's an analysis of the provided 510(k) summary regarding the KIM (Knotless Incontinence Mesh), focusing on the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary acts as a declaration of substantial equivalence rather than a detailed report of specific quantitative acceptance criteria or performance metrics beyond the material properties. The acceptance criteria are implicit in meeting established performance requirements and standards for medical devices of this type. The "reported device performance" section primarily lists the types of tests performed and broadly states that the product meets the requirements.
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Sterilization | Bioburden, Ethylene oxide residuals, Ethylene chlorohydrins residuals, Sterility assurance level (SAL) determination | "Results of verification testing indicate that the product meets the established performance requirements and standards." |
| Packaging | Expiration dating test | "Results of verification testing indicate that the product meets the established performance requirements and standards." |
| Biocompatibility | Cytotoxicity, Implantation, Sensitization with polar and non-polar extract, Genotoxicity, Acute systemic toxicity, Irritation, Haemolysis, Extractable metallic ions, Pyrogen test | "Results of verification testing indicate that the product meets the established performance requirements and standards." |
| Mechanical Properties (Mesh) | Suture pullout strength, Tensile break strength at break, Tear resistance, Pore size, Thickness, Density, Porosity, Traction threads-mesh strength. | |
| (Specific values reported in Device Description: Monofilament diameter = 0.14 mm, Tensile break strength = 180±20 Newton, Pore size = 1.45±0.40 mm, Thickness = 0.45±0.05 mm, Density = 59.8 g/m2, Porosity = 52.00 %) | "Results of verification testing indicate that the product meets the established performance requirements and standards." (And also meets the stated property values in the device description section). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify sample sizes for the test sets used in any of the performance tests (sterilization, packaging, biocompatibility, mechanical tests).
It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for these tests. This information is typically part of a detailed test report, not a 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the context of this 510(k) submission. This type of submission relies on engineering and laboratory testing against established standards for material and device performance, not on expert consensus for "ground truth" as you would find in an AI/diagnostic imaging study.
4. Adjudication Method for the Test Set
This is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or clinical endpoints, not for the physical and material testing described here.
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
An MRMC comparative effectiveness study was not performed or mentioned. This is a medical device approval for a physical surgical mesh, not an AI software device that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not performed. This is a physical medical device.
7. The Type of Ground Truth Used
For the physical and material tests, the "ground truth" is established by:
- Established industry standards and regulatory guidelines: These define acceptable ranges for properties like tensile strength, pore size, sterility, and biocompatibility.
- Predicate device characteristics: The properties of the predicate devices implicitly set a benchmark for acceptable performance. The summary states that the technological characteristics of the KIM mesh are substantially equivalent to the predicate devices.
- Laboratory test procedures: These procedures define how the "truth" (e.g., actual tensile strength, actual pore size) is measured and quantified.
8. The Sample Size for the Training Set
This is not applicable and not provided. There is no "training set" in the context of this device. This is not an AI/machine learning submission.
9. How the Ground Truth for the Training Set Was Established
This is not applicable and not provided, as there is no training set for this type of device submission.
§ 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.