(22 days)
The SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems are intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems are sterile, single use procedure kits that consist of two stainless steel, curved needle passers (also known as insertion tools); AMS polypropylene sling mesh and suture; and two plastic sheaths that cover and protect the sling mesh during placement.
The provided text is a 510(k) summary for the SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems, which are surgical meshes intended for the treatment of female stress urinary incontinence. This document details the device description, intended use, and a statement of technological comparison, but it does not contain information about specific acceptance criteria or a study that rigorously proves the device meets those criteria, as typically found in clinical studies with performance endpoints.
Here's an analysis based on the provided text:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics (e.g., success rate of incontinence treatment, complication rates, durability of the sling). The document focuses on demonstrating substantial equivalence to predicate devices.
- Reported Device Performance: Not provided with quantitative data. The application asserts that "the risk analysis and the verification/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." This is a qualitative statement of equivalence, not a direct report of performance against specific criteria.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- This information is not provided in the given text. The document is a regulatory submission focused on substantial equivalence rather than a detailed clinical trial report. It mentions "verification/validation activities" but does not detail their methodology or data.
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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):
- This information is not provided. The concept of "ground truth" as it applies to expert consensus for image analysis or diagnostic accuracy studies is not relevant to this type of device submission (surgical mesh).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable and therefore not provided. Adjudication methods are typically used in studies where multiple readers interpret data (e.g., imaging studies) and their interpretations need to be reconciled—this is not a diagnostic device.
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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 and therefore not provided. MRMC studies are specific to diagnostic devices, particularly those involving human interpretation of images, often with AI assistance. This device is a surgical implant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is not applicable and therefore not provided. This section refers to AI algorithm performance studies, which are irrelevant for a surgical mesh device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- "Ground truth" as understood in diagnostic device validation is not applicable here. For a surgical mesh, the "truth" would be related to clinical outcomes (e.g., resolution of SUI, complication rates), which would be assessed in clinical trials. The 510(k) summary references "risk analysis and the verification/validation activities," implying product testing and potentially some level of clinical data review from predicate devices, but no specific ground truth methodology is described for this specific submission.
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The sample size for the training set:
- This information is not provided. "Training set" is a term typically used in machine learning and AI development, which is not relevant to this device's regulatory submission.
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How the ground truth for the training set was established:
- This information is not applicable due to the nature of the device and the submission type.
In summary, the provided 510(k) document (K041948) is a regulatory submission primarily focused on demonstrating "substantial equivalence" of the new sling systems to previously cleared predicate devices. It argues that the new devices share similar technological characteristics and intended use, and that "risk analysis and the verification/validation activities... did not raise any new questions of safety or efficacy." This type of submission relies more on comparing features and known performance of predicate devices rather than presenting new, extensive clinical study data with specific acceptance criteria and performance outcomes for the new devices. Therefore, much of the requested detailed information regarding clinical study design, sample sizes, ground truth establishment, and expert involvement is not present in this document.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.