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The Bard® InnerLace™ BioUrethral Support System is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for use as a pubourethral sling for the treatment of stress urinary incontinence in women resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Bard® InnerLace" BioUrethral Support System consists of a Bard InnerLace™ System Pelvicol® implant and an introducer device to facilitate quick and simple placement of the implant. The Bard® InnerLace™ System Pelvicol® Implant is positioned suburethrally to provide a natural backboard for the urethra during abdominal pressure increases.

The introducer allows a choice of either suprapubic or retropubic implantation techniques depending on physician preference. The introducer set includes a removable handle, two introducer needles, and four snap-on tissue connectors.

The provided document describes a 510(k) summary for the Bard® InnerLace™ BioUrethral Support System. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way a new device's efficacy or safety study would.

Therefore, an acceptance criteria table and a detailed study proving the device meets those criteria, as typically understood for AI/ML device evaluations, are not present in this document.

Here's an analysis of the provided information in the context of the requested sections:

1. A table of acceptance criteria and the reported device performance:

   • Not Applicable. This document does not present specific quantitative acceptance criteria or performance metrics for the device. The 510(k) submission aims to demonstrate substantial equivalence, not to meet pre-defined performance thresholds through a new clinical or technical study as would be seen for a novel device. The "Performance Data Summary" explicitly states: "The Bard® InnerLace™ BioUrethral Support System is substantially equivalent to the predicate devices with regard to biocompatibility, materials and product characterization. The modified design of the Bard® InnerLace™ System Pelvicol® Implant does not raise any new types of safety or efficacy issues." This indicates a comparison to an existing device, not a new performance study against specific criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not Applicable. The document does not describe a test set or data provenance for a study. The information focuses on the device description and its intended use, asserting equivalence to a predicate device.

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):

   • Not Applicable. As no specific performance study with a test set is described, there's no mention of experts establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. No test set or associated adjudication method is described.

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:

   • Not Applicable. This device is a surgical mesh, not an AI/ML-driven diagnostic or imaging device. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and not mentioned.

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

   • Not Applicable. This is a physical medical device (surgical mesh), not an algorithm. Standalone algorithm performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not Applicable. No ground truth is established in the context of a new performance study. The substantial equivalence relies on the established safety and efficacy of the predicate device.

8. The sample size for the training set:

   • Not Applicable. This device is a surgical mesh, not an AI/ML system requiring a training set.

9. How the ground truth for the training set was established:

   • Not Applicable. Not an AI/ML system; no training set or ground truth for training is relevant.

In summary, the provided 510(k) submission for the Bard® InnerLace™ BioUrethral Support System is a regulatory document focused on demonstrating substantial equivalence to a legally marketed predicate device (Permacol® Acellular Collagen Matrix) based on manufacturing processes, materials, and product characterization, rather than presenting a performance study with specific acceptance criteria and test results for a novel device or AI/ML system.

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