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Sparc System: Intended for the placement of pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and /or intrinsic sphincter deficiency.
Monarc®, Monarc® +, Monarc® C Systems: Intended for the placement of suburethral mesh for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and /or intrinsic sphincter deficiency.

The Sparc, Monarc®, Monarc® +, and Monarc® C Systems are sterile, single use procedure kits that consist of two stainless steel, curved needle passers and a mesh sling assembly.

This 510(k) summary (K081613) describes the Sparc System, Monarc® System, Monarc® + System, and Monarc® C System, which are surgical mesh devices intended for the treatment of female stress urinary incontinence (SUI). The submission focuses on demonstrating substantial equivalence to predicate devices based on biocompatibility and performance requirements.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not provide a table of explicit acceptance criteria or detailed performance metrics. Instead, it makes a general statement: "The components of the Sparc, Monarc, Monarc +, and Monarc C Systems have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices." This implies that the acceptance criteria were met by demonstrating equivalence to the predicate devices in these areas, but the specific metrics are not detailed in this summary.

   Acceptance Criteria	Reported Device Performance
   Biocompatibility requirements (Implicit: must be equivalent to predicate devices)	"The components... have been tested for biocompatibility... and found to be substantially equivalent to the predicate devices." (Specific test results or metrics are not detailed in this summary.)
   Performance requirements (Implicit: must be equivalent to predicate devices for intended use)	"The components... have been tested for... performance requirements and found to be substantially equivalent to the predicate devices." (Specific performance metrics related to mechanical properties, mesh integrity, or other functional aspects for SUI treatment are not detailed in this summary.)

2. Sample size used for the test set and the data provenance:

   The 510(k) summary does not provide any information about the sample size used for comparative testing or the data provenance (e.g., country of origin, retrospective/prospective). The statement suggests testing was performed on "components," which could imply bench testing rather than clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   This information is not provided in the document. The submission relies on substantial equivalence to predicate devices based on non-clinical testing (biocompatibility and performance), not on establishing ground truth for a test set through expert review.

4. Adjudication method for the test set:

   This information is not provided. Given the nature of the submission (substantial equivalence based on component testing), an adjudication method for a clinical test set would not typically be relevant or present.

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 as the device is a surgical mesh for stress urinary incontinence, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness metrics are present.

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

   This information is not applicable as the device is a surgical mesh, not an algorithm or AI system.

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

   The concept of "ground truth" as typically applied in diagnostic or AI device evaluations is not directly applicable here. The "ground truth" in this context would implicitly be the established safety and efficacy of the predicate devices for their indicated uses, against which the new device components' biocompatibility and performance are compared. The summary does not detail the specific data or methods used to establish this "ground truth" for the predicates, though it would typically involve clinical data (outcomes data) and regulatory approvals of those predicates.

8. The sample size for the training set:

   This information is not applicable as the device is not an AI/ML algorithm requiring a training set.

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

   This information is not applicable as the device is not an AI/ML algorithm.

In summary, this 510(k) notification for surgical mesh devices primarily relies on demonstrating substantial equivalence to predicate devices through biocompatibility and in vitro performance testing of the components. It does not involve clinical studies with human participants, expert review of data, or AI/ML algorithm validation. Therefore, many of the requested details regarding clinical study design, expert involvement, and AI performance metrics are not relevant or provided in this type of submission.

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