(449 days)
Ophira™ Mini Sling System is intended to be used for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
Ophira™ Mini Sling System consists of a sterile polypropylene sling and a sterile retractable insertion guide for sling placement. The sling is composed of monofilament polypropylene mesh between two polypropylene fixation arms; the fixation arms have multiple fixation points along the arms, which is the basis of the autofixing system, i.e., the two fixation arms are self anchored to the internus transobturator muscle and, therefore, the sling needs no sutures. An easily identifiable mark in the center of the mesh sling helps to achieve a symmetrically centered location for the proper placement of the sling. The sling has a suture inserted onto each fixation arm to provide the ability to adjust tension, if necessary, during the procedure for optimum suburethral support. These sutures are removed once the implantation procedure is completed.
This document is a 510(k) summary for the Ophira™ Mini Sling System, a medical device for treating female stress urinary incontinence. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves acceptance criteria for the new device. Therefore, the information requested regarding acceptance criteria and performance studies is not fully present in the provided text.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a study for the Ophira™ Mini Sling System itself. Instead, it relies on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (Reference) |
|---|---|
| Bio-compatibility | "Sling is composed of monofilament polypropylene mesh" (implied bio-compatible as per predicate and common use for surgical mesh) |
| Mechanical Properties (e.g., tensile strength, pore size, material degradation) | Not explicitly stated, but assumed to be comparable to the predicate device, MiniArc Precise™ Single-Incision Sling (K100807), which has presumably met such criteria. |
| Functionality and Ease of Use | Described as having a "sterile retractable insertion guide," "autofixing system" with fixation points, and "suture inserted onto each fixation arm to provide the ability to adjust tension." Implied to function similarly to predicate. |
| Sterility | "Consists of a sterile polypropylene sling and a sterile retractable insertion guide" |
| Intended Use | "Treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD)." This matches the intended use of comparable devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The provided text does not contain information about a test set sample size or data provenance for a performance study of the Ophira™ Mini Sling System. The 510(k) summary focuses on substantial equivalence based on material, design, and intended use comparison to a predicate device, rather than patient performance data for the new device.
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):
This information is not provided in the document as there is no described clinical performance study or test set with ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document as there is no described clinical performance study requiring adjudication.
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 is not applicable. The device is a surgical sling, not an AI-assisted diagnostic tool or a device where "human readers" would be involved in interpreting results.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
As no performance study with a test set is described, no ground truth is mentioned for the Ophira™ Mini Sling System. The "ground truth" for the 510(k) submission is the established safety and effectiveness of the legally marketed predicate device, the MiniArc Precise™ Single-Incision Sling (K100807), and the demonstration that the new device is substantially equivalent in its characteristics.
8. The sample size for the training set:
This is not applicable. The device is a physical surgical implant and not an AI/machine learning model that would require a training set.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for a machine learning model.
§ 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.