(208 days)
To be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The device consists of a polypropylene sling with integral serrated anchoring arms. The sling has an overall length of 14cm. It is supplied with two metal needles to aid in surgical placement of the device. The device is supplied sterile.
This is a 510(k) premarket notification for a medical device called "Gyne Ideas Minitape RP™", which is a polymeric surgical mesh intended for use as a pubourethral sling for the treatment of female urinary incontinence.
The provided text only contains a 510(k) summary and the FDA's clearance letter. It does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial report or a detailed testing protocol would. The 510(k) process is about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving efficacy through extensive clinical studies with specific performance metrics against pre-defined acceptance criteria, especially for Class II devices.
Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from this document because it is not present. The document focuses on device description, intended use, and comparison to predicate devices, along with some general mentions of testing.
Here's a breakdown of what can be extracted and what information is not provided:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantifiable acceptance criteria with numerical targets. The closest is the general statement about testing ensuring "adequate restraint of urethral tissue under conditions in excess of those encountered during normal clinical use."
- Reported Device Performance: No specific numerical performance metrics are reported in this summary.
| Acceptance Criteria (Not explicitly stated in numerical terms within this document) | Reported Device Performance (No specific numerical data provided in this document) |
|---|---|
| Ability to adequately restrain urethral tissue under conditions in excess of normal clinical use. | "The device has been subjected to in-vitro and in-vivo testing which demonstrate the ability of the device to adequately restrain urethral tissue under conditions in excess of those encountered during normal clinical use." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing is described generally as "in-vitro and in-vivo testing."
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. The document makes no mention of experts or how ground truth was established for "in-vivo" studies, if they were clinical. Given the nature of a 510(k) for a surgical mesh, the "in-vivo" testing might refer to animal studies or biomechanical testing, rather than human clinical trials with expert assessment, though this is not clear.
4. Adjudication method for the test set
- This information is not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, an MRMC comparative effectiveness study was not done or at least not reported in this 510(k) summary. This type of study is typically for diagnostic imaging devices involving multiple human readers interpreting cases. This device is a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical surgical mesh, not an algorithm or AI.
7. The type of ground truth used
- The document implies that the "testing" (in-vitro and in-vivo) would have objective measures related to tissue restraint. However, the specific "type of ground truth" (e.g., pathology, direct measurement of tissue support, clinical outcomes) for the "in-vivo" component is not detailed.
8. The sample size for the training set
- This question is not applicable as the device is a physical surgical mesh, not an AI or algorithm that requires a training set.
9. How the ground truth for the training set was established
- This question is not applicable for the same reason as above.
Summary of Device and Testing (from the provided text):
- Device: Gyne Ideas Minitape RP™, a polypropylene sling with integral serrated anchoring arms, 14cm long, supplied with two metal needles, sterile.
- Intended Use: To be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
- Testing: "The device has been subjected to in-vitro and in-vivo testing which demonstrate the ability of the device to adequately restrain urethral tissue under conditions in excess of those encountered during normal clinical use."
- Predicate Devices: Several previously cleared surgical mesh devices are listed, indicating the substantial equivalence pathway for this submission.
The 510(k) summary focuses on demonstrating that the device is substantially equivalent to existing legally marketed devices, rather than presenting a detailed clinical study with quantifiable performance metrics against specific acceptance criteria. For many Class II devices cleared via 510(k), extensive clinical trial data with predefined acceptance criteria and detailed reporting of expert involvement might not be required, especially if performance can be established through bench testing and comparison to predicates.
§ 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.