(30 days)
Advantage Ultra System and Advantage Fit Ultra System
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 and the Advantage Fit Ultra System delivery devices are intended for use as an aid in insertion, placement, fixation, and anchoring of the Advantage Ultra surgical mesh during urogynecological procedures.
Lynx Ultra System
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 Lynx Ultra System delivery device is intended for use as an aid in insertion, placement, fixation, and anchoring of the Lynx Ultra surgical mesh during urogynecological procedures.
Advantage Ultra System and Advantage Fit Ultra System
The Advantage Ultra System and the Advantage Fit Ultra System are sterile, single-use systems each consisting of one delivery device and one blue 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 and the Advantage Fit Ultra Systems are each packaged with their respective delivery device (Advantage Ultra or Advantage Fit Ultra delivery device). 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 includes the same mid-urethral mesh implant as the Advantage Ultra System but differs in the design of the dilators and delivery devices. The needle portion of the Advantage Fit Ultra delivery device has a smaller outer diameter and a smaller bend radius and is offered to provide physicians with surgical options. The Advantage Fit Ultra dilators also have a smaller diameter to accommodate for the different needle size.
Lynx Ultra System
The Lynx Ultra System is a sterile, single-use system consisting of two delivery devices and one blue 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.
This document is a 510(k) summary for the Advantage™ Ultra System, Advantage Fit™ Ultra System, and Lynx™ Ultra System, surgical mesh devices for treating female stress urinary incontinence. The core of this submission is to demonstrate that these devices are substantially equivalent to previously cleared predicate devices (K211223). The primary change in these new submissions is related to procedural steps in the electronic Instructions for Use (eIFU), specifically regarding the release and removal of disposable components of the mesh assembly.
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are focused on ensuring that the changes (eIFU modifications) do not negatively impact safety or effectiveness, and that the device remains substantially equivalent to its predicate. There isn't a traditional performance study proving clinical efficacy against a disease endpoint, as this is a 510(k) submission for substantial equivalence.
Here's an interpretation of your request based on the provided document:
Acceptance Criteria and Device Performance (in the context of a 510(k) for eIFU changes)
Since the document explicitly states "there are no changes to the intended use or indications for use, design, materials, sterilization, technological and performance characteristics, or principle of operation," the acceptance criteria are implicitly tied to demonstrating that the eIFU modifications do not introduce new safety or effectiveness concerns and allow the device to function as intended.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| 1. User Needs Met: All user needs impacted by eIFU modifications are adequately addressed. | Design Validation: "objective evidence that all user needs impacted by the eIFU modifications were met and overall performance for the intended clinical use was acceptable." |
| 2. Functionality Maintained: Ultra Products continue to function as intended with the new eIFU. | Summative Usability Evaluation: Demonstrated that "the Ultra Products continue to function as intended." |
| 3. No New Safety/Effectiveness Issues: eIFU changes do not introduce new issues of safety or effectiveness compared to predicate devices. | Summative Usability Evaluation: Demonstrated that the Ultra Products "do not raise new issues of safety or effectiveness compared to the predicate devices." |
| Overall Conclusion: "concluded that the proposed Ultra Products are substantially equivalent to the established predicate devices." |
Study Details
The studies performed are "Performance bench testing" in the form of "Design Validation" and a "Summative Usability Evaluation."
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact number of participants (users) or instances for the "Design Validation" and "Summative Usability Evaluation." It refers generally to "performance bench testing."
- Data Provenance: Not specified, but "bench testing" typically implies laboratory or simulated environments, not patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the sense of clinical "ground truth" (e.g., pathology, outcomes). The "ground truth" here is the successful and safe use of the device according to the eIFU. The design validation and usability studies themselves aim to verify this by testing user interaction and performance. The document does not specify the number or qualifications of evaluators/experts involved in conducting or assessing these bench tests.
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Adjudication method for the test set:
- Not explicitly stated. For bench testing and usability studies, adjudication might involve expert review of test results, error analysis, and user feedback, but no specific method like "2+1" or "3+1" is mentioned.
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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/imaging device. The study type is bench testing and usability evaluation for a surgical mesh delivery system with modified instructions for use.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical device (surgical mesh and delivery system), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this submission's studies is the successful and safe operation of the device according to the updated eIFUs. This is assessed via controlled testing environments (bench testing) and usability studies, rather than clinical endpoints, pathology, or outcomes data, as this 510(k) specifically addresses changes to the instructions for use, not the fundamental device design or clinical performance.
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The sample size for the training set:
- Not applicable. This is not a machine learning/AI device, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable (as above).
§ 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.