(29 days)
The MONARC™ Sling System is 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 MONARC Sling System is a sterile, single use procedure kit consisting of two stainless steel, 22cm spiral needle passers (also called insertion tools) and one AMS polypropylene sling mesh with attached dilating connectors. The dilating connectors attach to the keyed ends of the MONARC needle passers during the procedure to facilitate sling placement. A fixed absorbable PGA tensioning suture runs through the middle of the sling mesh. Two plastic sheaths overlap in the center of the sling mesh and protect it during placement.
This submission is a 510(k) premarket notification for a medical device called the MONARC™ Sling System. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on detailed acceptance criteria and a study proving device performance against those criteria in the way envisioned by the request. As such, much of the requested information is not present in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria or quantitative performance metrics for the MONARC™ Sling System in the context of clinical outcomes or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to its predicate device. This type of submission would typically involve engineering tests and potentially animal studies, but not a human clinical trial with performance metrics.
2. Sample size used for the test set and the data provenance:
Not applicable. This document does not describe a clinical study with a "test set" for performance evaluation in the typical sense. It's a 510(k) submission focused on equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth establishment is not described as this is not a diagnostic device study.
4. Adjudication method for the test set:
Not applicable.
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 is not an AI/diagnostic device study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm/AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that would have a "training set."
9. How the ground truth for the training set was established:
Not applicable.
Summary of what the document does provide regarding acceptance/equivalence:
- Device Description: The MONARC™ Sling System is a sterile, single-use procedure kit consisting of spiral needle passers and a polypropylene sling mesh with attached dilating connectors and an absorbable tensioning suture.
- Intended Use: Placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
- Comparison to Predicate Device: The fundamental scientific technology is unchanged from the SPARC™ Sling System (K011251, K013355, K020663, K021263). The primary change is the shape of the needle (spiral instead of curved). The sling mesh and absorbable suture remain the same.
- Supporting Information: A risk analysis and verification/validation activities were reported to substantiate equivalence and did not raise new questions of safety or effectiveness.
- Conclusion: The MONARC™ device is substantially equivalent to the predicate with respect to intended use and technological characteristics.
In the context of a 510(k) submission like this, "acceptance criteria" largely refer to the successful demonstration of substantial equivalence through design verification and validation activities (e.g., biocompatibility testing, sterility testing, mechanical testing of materials, and comparison to the predicate device's performance from existing data), as well as clinical safety and effectiveness through published literature or predicate device history. The document explicitly states that "verification and validation activity reported in this 510(k) application substantiate equivalence to the predicate." However, the specifics of these tests and their numerical acceptance criteria are not provided in this summary.
§ 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.