Search Results

The Altis Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The Aris Transobturator Kit consists of the Aris implantable midurethral support sling and disposable introducers. The Aris sling and introducers are indicated for the surgical treatment of all types of stress urinary incontinence (SUI) and for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Supris Retropubic Kit consists of the Supris implantable midurethral support sling and disposable introducers for placement using a "top-down" or "bottom-up" retropubic surgical approach. The Supris sling and introducers are indicated for the surgical treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Coloplast Altis Single Incision Sling (SIS) System includes one implantable single incision midurethral sling and two Altis introducer needles. The Altis Single Incision Sling System is provided sterile (ethylene oxide sterilization) and is for single use only.

The Altis Single Incision Sling is an implantable, synthetic, knitted, low-elasticity, monofilament polypropylene, single incision midurethral sling. The mesh sling body measures approximately 7.75 cm long by 1.1cm wide. The Altis sling assembly is connected on each end to an anchor. One end of the sling assembly is connected to a short length of USP size 1 polypropylene monofilament suture connected to a static (non-tensioning) polypropylene anchor. The other end of the sling connects to a longer length of suture with a dynamic (tensioning) polypropylene/polyurethane anchor. The dynamic anchor is intended to allow intraoperative adjustment and tensioning of the sling, resulting in urethral support during instances of increased abdominal pressure, thereby preventing urine leakage. The Altis sling is non-absorbable and is intended to be permanent.

The Altis introducers are helical-type instruments (one right), used to assist in the surgical placement of the Altis Single Incision Sling a transobturator technique, via a single incision vaginal approach. The introducers are manufactured from polycarbonate (handles) and medical grade stainless steel (needles). These introducers are only to be used with the Altis Single Incision Sling System in accordance with the Instructions for Use.

The Coloplast Aris Transobturator Sling System includes an implantable midurethral sling and disposable introducer needles. The Aris sling and Aris introducers are provided sterile (ethylene oxide sterilization) and are for single use only.

The Aris sling is a synthetic, knitted, low-elasticity, midurethral sling made from monofilament polypropylene. The Aris sling is non-absorbable and intended to be permanently implanted.

Aris introducers (helical pair and flat curve) are instruments used to assist in the correct surgical placement of the Aris sling via the transobturator approach. The introducers are manufactured from polycarbonate (handles) and medical grade stainless steel (needles). These introducers are only to be used with the Aris sling.

The Coloplast Supris Retropubic Sling System includes an implantable midurethral sling and disposable introducer needles. The Supris sling and Supris introducers are provided sterile (ethylene oxide sterilization) and are for single use only.

The Supris sling is a synthetic, knitted, low-elasticity, midurethral sling made from monofilament polypropylene. The Supris sling is non-absorbable and intended to be permanently implanted.

The Supris introducers are instruments used to assist in the correct surgical placement of the Supris sling via a retropubic approach. The introducers are manufactured from polycarbonate (handles) and medical grade stainless steel (needles). These introducers are only to be used with the Supris sling.

No information regarding acceptance criteria or a study proving the device meets acceptance criteria for an AI/ML powered medical device, as described in the prompt's requested information points (1-9), is available in the provided text.

The document discusses the substantial equivalence (510(k) clearance) of a physical medical device: the Altis Single Incision Sling System, Aris Transobturator Sling System, and Supris Retropubic Sling System, which are surgical meshes for treating stress urinary incontinence.

The "Performance Data" section (VII) lists various bench testing conducted to support the substantial equivalence determination for changes to the mesh material, including:

• Biocompatibility Testing (ISO 10993-1)
• Performance Testing (Mesh Density, Thickness, Pore Size, Sling Length, Width, Tensile Strength, Elongation at Break, Elasticity, Stiffness, Suture Pull-Out Strength, Mesh Tear Resistance, Suture/Mesh Weld Strength, Shelf-life testing)
• Sterilization (Ethylene Oxide)
• Packaging and Distribution

The document explicitly states: "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices." This confirms that there was no human reader study, no standalone algorithm performance, or any of the other AI/ML specific criteria mentioned in the prompt.

Ask a specific question about this device

The Supris Retropubic Sling System is an implantable, suburethral, support tape indicated for the surgical treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The sling is placed retropubically using two disposable introducers using either a "top down" or "bottom up" surgical approach

The Supris Retropubic Sling System is a permanent, synthetic sub-urethral sling that is provided with disposable needles in the system. The Supris sling is made from knitted monofilament polypropylene and has low elasticity. This structure gives the Supris sling resistance to traction, allows for tissue colonization and facilitates positioning during surgery.

This document, K111233, is a 510(k) premarket notification for the Supris® Retropubic Sling System, a surgical mesh for treating female stress urinary incontinence.

Here's an analysis of the provided text in the context of acceptance criteria and a study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain any specific acceptance criteria or quantitative performance metrics for the device itself (e.g., success rates, complication rates, or objective measures of SUI improvement). The submission is a name change and labeling update (specifically adding a "bottom-up" surgical approach) to an already cleared device.

Instead, the submission states:

"The safety and effectiveness of both the top-down and the bottom-up approaches were evaluated based on a review of published scientific literature on other tension-free retropubic female urinary incontinence slings."

"The results of this review determined that both approaches are comparable in terms of risks and the occurrence of related adverse events." |
| Substantial Equivalence | "The changes cited in this submission do not affect substantial equivalence established in the original submission." |

2. Sample Size Used for the Test Set and Data Provenance

The submission does not refer to a "test set" in the context of device performance testing for this specific K111233 submission. This is because the device itself received its initial substantial equivalence in a previous 510(k) (K053296, the predicate device). This current submission is for a labeling update and name change.

The "study" mentioned for the comparison of surgical approaches is a review of published scientific literature on other tension-free retropubic female urinary incontinence slings. Therefore, there is no specific sample size from a primary study on the Supris device for this submission, and the data provenance is retrospective, derived from existing published literature, likely from various countries as it refers to "scientific literature" generally.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since there was no primary test set or clinical trial conducted for this specific submission's labeling update, there were no experts explicitly used to establish ground truth in the way one would for a new device's performance evaluation.

The "review of published scientific literature" would implicitly rely on the expertise of the authors of those published papers, who are likely surgeons and researchers in the field of urology/gynecology. However, the submission does not specify the number or qualifications of individuals who performed this specific review of the literature.

4. Adjudication Method for the Test Set

As there was no primary test set for this K111233 submission, there was no adjudication method described. The conclusion about the comparability of surgical approaches was drawn directly from the literature review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No. This device is a surgical sling, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a physical surgical implant, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used

For the purpose of this K111233 submission's justification for adding the "bottom-up" approach, the "ground truth" was established by "review of published scientific literature" on the safety and effectiveness of different surgical approaches for similar devices. This can be considered a form of expert consensus derived from the collective knowledge and findings reported in peer-reviewed medical literature.

8. The Sample Size for the Training Set

There is no training set in the context of this 510(k) submission. This is not a machine learning or AI device.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set, this question is not applicable.

In Summary:

The K111233 submission is primarily for a labeling change (addition of a "bottom-up" surgical approach) and a name change for an already cleared device. It explicitly states that no new clinical trials were conducted for the Supris Retropubic Sling System to compare the two surgical approaches. Instead, the justification for the equivalency of the two approaches relies on a retrospective review of published scientific literature pertaining to other tension-free retropubic female urinary incontinence slings. Therefore, the concepts of "acceptance criteria," "test set," "training set," "ground truth establishment with experts," or "AI performance studies" as typically applied to novel diagnostic or AI devices, are not directly relevant to this specific premarket notification. The FDA's decision to clear the device was based on the conclusion that the changes did not affect the substantial equivalence established in the original submission.

Ask a specific question about this device