Search Results

Ajust® Helica! Adjustable Single-Incision Sling is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Ajust® Helical Adjustable Single-Incision Sling System is a sterile, single use procedure kit that consists of a mesh sling implant and instruments, flexible stylet and two helical shaped introducers, which aid in the placement of the mesh in the pelvic floor. The product is offered in a single kit and dispenser pack of 5 individual kits. The sling implant is composed of four primary components - polypropylene flat mesh, polypropylene tube mesh, polypropylene anchors and a polypropylene sling lock. The adjusting tab is only used during adjustment and is not part of the permanent implant. The flexible stylet is a thin, flexible, Nitinol wire that allows the stylet to conform and flex to follow the path of the tube mesh to push the sling lock into position. The stainless steel helical shaped introducers allow for placement of the anchors in the obturator membrane/muscle by rotation of the handle of the introducer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Ajust® Helical Adjustable Single-Incision Sling:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document does not provide specific numerical acceptance criteria or detailed results for each test. Instead, it broadly states that the tests were performed for "design verification and validation" and that the product performance is "substantially equivalent" to the predicate device. This is common for 510(k) submissions, especially for modifications to existing devices, where the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate.

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

This information is not provided in the document. The text describes a series of "design verification and/or validation testing" on the modified introducers, but it does not specify the number of units tested, the origin of any data (e.g., in-house lab testing, animal studies, human clinical studies), or whether it was retrospective or prospective. Given the nature of the submission (Special 510(k) for a device modification), it's highly likely these were bench tests performed internally by the manufacturer.

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/not provided in the context of this 510(k) submission. The "ground truth" here is the successful performance of the device's mechanical and biocompatibility characteristics, determined through engineering tests rather than expert interpretation of medical images or outcomes.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth for subjective assessments, such as interpreting diagnostic images. The tests described are engineering and materials assessments.

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/not provided. An MRMC comparative effectiveness study is used for evaluating diagnostic imaging AI. The Ajust® Helical Adjustable Single-Incision Sling is a surgical mesh product, not a diagnostic AI tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not provided. This device is a physical surgical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for this device's "performance data summary" appears to be based on engineering specifications and established test methodologies to evaluate the mechanical properties and biocompatibility of the introducers. For example, "Introducer compression and side load strength" would have a pre-defined acceptance range based on engineering requirements for the device's function. The ultimate "ground truth" for the overall device is its demonstrated "substantial equivalence" to the predicate device, meaning it performs as expected for its intended use based on these tests.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a physical medical device, not an AI model that requires a "training set."

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

This information is not applicable/not provided for the same reason as point 8.

Ask a specific question about this device