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The Monarc and BioArc TO Subfascial Hammocks are intended for the placement of a suburethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and / or intrinsic sphincter deficiency.

The Monarc and BioArc TO Subfascial Hammocks are suburethral sling procedure that rne Moharo and Blor .. orgical approach to treat stress urinary incontinence. They are uses a transoblarator ourgrout approcessions of two stainless steel curved needle passers and a mesh or mesh and graft sling assembly.

The provided text is a 510(k) summary for the Monarc and BioArc TO Subfascial Hammocks. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than conducting new clinical studies with defined acceptance criteria and detailed performance reporting. Therefore, much of the requested information about device performance, study design, and ground truth establishment is not present in this document.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative measures like sensitivity, specificity, or minimum clinical improvement. The primary acceptance criterion for a 510(k) is demonstrating "substantial equivalence" to a legally marketed predicate device. This is a qualitative assessment based on intended use, technological characteristics, and performance.
• Reported Device Performance: The document states:
  • "The Indications for Use, fundamental scientific technology, surgical approach, sling placement, and materials are all the same as the predicates."
  • "The risk analysis and validation activities reported in this Special 510(k) application substantiate equivalence to the predicate devices and did not raise any new questions of safety or efficacy."
  • "The Monarc and BioArc TO + and C Subfascial Hammock versions are substantially equivalent to their predicates with respect to intended use, technological characteristics, and performance."

Since this is a substantial equivalence claim, there are no specific performance metrics like sensitivity or specificity reported for the Monarc and BioArc TO devices themselves in comparison to specific quantitative thresholds. The "performance" assessment here refers to the device behaving similarly to the predicate devices and not introducing new safety or efficacy concerns.

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

• Not Applicable/Not Provided: The document does not describe a test set or a study that uses a specific sample size of patients or images to evaluate the performance of the Monarc and BioArc TO devices. The submission relies on demonstrating equivalence to predicate devices, which would have undergone their own validation. The term "validation activities" is mentioned, but no details regarding sample size or provenance are provided for these activities.

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

• Not Applicable/Not Provided: There is no mention of a test set, experts, or ground truth establishment in the context of a new study for the Monarc and BioArc TO devices.

4. Adjudication Method for the Test Set:

• Not Applicable/Not Provided: As no specific test set is detailed, no adjudication method is mentioned.

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 for stress urinary incontinence, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers improving with AI assistance is not relevant or described.

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 or AI system.

7. The Type of Ground Truth Used:

• Not Applicable/Not Provided: Due to the nature of a 510(k) submission for a physical device, and the lack of a new clinical study detailed in this document, no specific "ground truth" (like pathology or outcomes data) for a new test set is described. The "ground truth" in a 510(k) for a device like this often relates to established safety and performance of the predicate devices.

8. The Sample Size for the Training Set:

• Not Applicable/Not Provided: This device is not an AI algorithm that would typically have a "training set."

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

• Not Applicable/Not Provided: As above, this concept doesn't apply to this type of device and submission.

Summary of Approach in this 510(k) Document:

This 510(k) submission (K051530) for the Monarc and BioArc TO devices follows a substantial equivalence pathway. It relies on demonstrating that the new devices are essentially the same as already legally marketed predicate devices (Monarc Subfascial Hammock, K023516, and BioArc TO Subfascial Hammock, K040538). The "study" (referred to as "validation activities") is presented as substantiating this equivalence, implying that no new, extensive clinical trials with specific performance metrics were required or conducted for this submission. The focus is on showing that the new devices share the same intended use, technological characteristics, surgical approach, sling placement, and materials as the predicates, thereby not raising new safety or efficacy questions.

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