(89 days)
The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The Advantage Ultra System is a sterile, single-use system consisting of one delivery device and one mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. The two dilators at the distal ends of the mesh assembly are designed to be placed over the needle end of the delivery device. The Advantage Ultra System is packaged with the Advantage™ System Delivery Device previously cleared via K172565. This is a single-use disposable delivery device that consists of a handle with a curved needle and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for retropubic placement.
The Advantage Fit Ultra System is a sterile, single-use system consisting of one delivery device and one mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. The two dilators at the distal ends of the mesh assembly are designed to be placed over the needle end of the delivery device. The Advantage Fit Ultra System is packaged with the Advantage Fit™ System Delivery Device previously cleared via K172565. This is a single-use disposable delivery device that consists of a handle with a curved needle and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for retropubic placement.
The Lynx Ultra System is a sterile, single-use system consisting of two delivery devices and one mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. At the distal ends of the mesh assembly there are association loops designed to be placed in the needle slot of the distal end of a delivery device. The Lynx Ultra System is packaged with two Lynx System Delivery Devices previously cleared via K172565. Each is a single-use disposable delivery device that consists of a handle with a curved needle with a needle slot for connection to the mesh assembly. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for suprapubic placement.
The provided text describes the 510(k) summary for the Advantage™ Ultra System, Advantage Fit™ Ultra System, and Lynx™ Ultra System, which are surgical meshes for treating female stress urinary incontinence. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study or a standalone algorithm performance study.
Therefore, the information required for "a table of acceptance criteria and the reported device performance" and the details of a study proving those criteria are not explicitly present in the provided text in the way one might expect for a typical performance validation study with specific metrics like sensitivity, specificity, or accuracy for an AI/CADe device.
However, based on the provided text, the closest interpretations for acceptance criteria and the "study" demonstrating their fulfillment are related to performance testing to ensure the device functions as intended and meets specifications compared to its predicates.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria (e.g., minimum tensile strength value) explicitly alongside reported performance results. Instead, it broadly states that performance testing was conducted, and the results "demonstrate that the proposed products function as intended and meet specification requirements."
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Functional & Mechanical | |
| Dimensional Tests | Products function as intended and meet specification requirements. |
| Tensile Strength Tests | Products function as intended and meet specification requirements. |
| Full Functional Tests | Products function as intended and meet specification requirements. |
| Usability | |
| User Evaluations | Products function as intended and meet specification requirements. |
| Packaging & Sterility | |
| Packaging Tests | Products function as intended and meet specification requirements. |
| Sterility | Products function as intended and meet specification requirements. |
| Biocompatibility | |
| Biocompatibility Testing | All patient contacting materials meet applicable biocompatibility standards per ISO 10993-1:2018 and FDA Guidance. |
| Shelf Life | |
| Accelerated Aging (13 months) | Performance testing on non-aged and accelerated aged samples supports a 1-year shelf life. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for the performance tests (dimensional, tensile, functional, user evaluations, packaging, sterility, biocompatibility). It also does not mention the data provenance in terms of country of origin or whether a retrospective or prospective study was conducted for establishing clinical performance (as this submission is focused on substantial equivalence based on materials and design, not clinical outcomes from a trial). The "samples" referred to are likely physical devices or components of the device itself (non-aged and accelerated aged for shelf life testing).
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)
This information is not applicable and not provided in the document. The performance tests described (dimensional, tensile, functional, biocompatibility, sterility) are technical evaluations of the device's physical properties and safety, not assessments requiring expert "ground truth" in a clinical diagnostic sense. "User evaluations" are mentioned, which would involve experts (e.g., surgeons or medical professionals) interacting with the device, but the number and qualifications are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads) to establish ground truth or handle discrepancies, neither of which is described as part of the performance testing for this surgical mesh.
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 is not applicable as the device is a surgical mesh, not an AI/CADe system for diagnostic imaging interpretation. Therefore, no MRMC study or AI-related effectiveness details are provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance testing, the "ground truth" would be the established engineering specifications, material standards (e.g., ISO 10993-1:2018 for biocompatibility), and regulatory requirements for sterility and packaging integrity. These are objective measures and standards rather than clinical "ground truth" derived from patient data or expert consensus on a diagnosis.
8. The sample size for the training set
This is not applicable as the device is a physical surgical mesh, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is a physical surgical mesh, not an AI model.
§ 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.