(219 days)
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 + and 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 device is a sterile, single use procedure kit consisting of: Two stainless steel, curved, 21-cm long, needle passers. One end of each . needle passer is keved to allow for secure placement of the connectors. Each needle passer has a plastic handle attached. One piece of AMS Polypropylene sling mesh with attached connectors. The AMS . Polypropylene sling mesh is constructed of polypropylene monofilament that is precut to 1.1 cm width x 50 cm length. An absorbable tensioning suture is threaded into the length of the sling mesh to allow for tensioning adjustment of the sling mesh after placement in the patient is achieved. Two plastic sheaths that overlap in the center of the sling mesh cover the sling mesh and protect it during placement. The connectors are attached to the vaginal ends of the Sparc needle passers during the procedure. The AMS Polypropylene sling mesh is intended to remain in the body as a permanent implant and the mesh component is not absorbed or degraded by the action of tissue ingrowth or tissue enzymes.
The Monarc devices are sterile, single use procedure kits, each consisting of: Two stainless steel, curved needle passers. The tip portion of each needle . passer is configured to allow for secure placement of the connectors. Each needle passer has a plastic handle attached. An assembly including one piece of loosely knitted polypropylene mesh, two . removable plastic insertion sheaths attached to the mesh, and two connectors attached to the insertion sheaths. The mesh is constructed of polypropylene monofilament. An absorbable tensioning suture is threaded into the length of the mesh to allow for tensioning adjustment of the mesh after placement in the patient is achieved. The plastic covering also affords convenient travel of the mesh through the tissue. The connectors are attached to the tip portions of the Monarc needle passers during the procedure. The loosely knitted polypropylene mesh is intended to remain in the body as a permanent implant. The mesh component is not absorbed or degraded by the action of tissue in-growth or tissue enzymes.
This document is a 510(k) summary for a medical device (Sparc™ Sling System and Monarc™, Monarc™ + and Monarc™ C Subfascial Hammock Systems). It is a regulatory submission for demonstrating substantial equivalence to a predicate device, not a study demonstrating device performance against specific acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not available within this document. The document primarily focuses on establishing that the proposed device is substantially equivalent to a previously cleared predicate device, meaning it has the same intended use, technological characteristics, and safety/effectiveness profile.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Not applicable. This document does not present a table of acceptance criteria or new device performance data. The basis of this 510(k) is that the "Proposed Device Description" and "Summary of the Technical Characteristics Compared to the Predicate Device(s)" state: "All characteristics of the proposed device are identical to those of the predicate, including design, material construction, manufacturing process, and intended use. There is no change to the technical characteristics for this 510(k)." This implies that the acceptance criteria and performance are presumed to be the same as the predicate device.
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. No new clinical or performance test set is described. This device is cleared based on substantial equivalence to a predicate, not new performance testing against a test set.
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. No ground truth establishment for a test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set or 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 document is for a surgical mesh system for SUI, not an AI software/device. Therefore, MRMC studies or AI involvement are irrelevant and not discussed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No ground truth for device performance is described as this is a substantial equivalence submission, not a de novo performance study.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established:
- Not applicable. No training set or ground truth for it is relevant or described.
Summary based on the provided text:
This 510(k) submission for the Sparc™ Sling System and Monarc™, Monarc™ + and Monarc™ C Subfascial Hammock Systems does not contain a study proving that the device meets specific acceptance criteria via new performance data. Instead, it relies on the principle of substantial equivalence to a previously cleared predicate device (Sparc Sling System and Monarc, Monarc + and Monarc C Subfascial Hammock device; K081613). The document explicitly states that the proposed device is identical in all characteristics (design, material, manufacturing, and intended use) to its predicate. Therefore, its safety and effectiveness are considered to be equivalent to the predicate, and no new performance studies are presented or required for this type of submission.
§ 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.