Search Results

The Minitape* Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The subject device is a totally disposable tape mesh intended to be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. It consists of a polypropylene tape with integral fixation zones on either side of a central mesh sling. These fixation zones at the ends of the tape anchor the sling to surrounding soft tissues.

The provided text is a 510(k) summary for the "Modified Minitape* Urethral Sling" and primarily discusses regulatory information, device description, and indications for use. It briefly mentions "in-vitro and in-vivo testing" that "demonstrate the ability of the device to adequately restrain urethral tissue," but it does not contain the detailed information required to answer the specific questions about acceptance criteria, study design, sample sizes, ground truth, or expert qualifications.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed study information based on the provided text. The document states that testing was performed, but it does not describe the specific study (or studies), their methodologies, or their results in a way that allows for the extraction of the requested information.

Missing Information:

• Acceptance Criteria Table: The document does not specify any quantitative or qualitative acceptance criteria for device performance.
• Sample sizes (test set), data provenance: Not mentioned.
• Number and qualifications of experts for ground truth: Not mentioned.
• Adjudication method: Not mentioned.
• MRMC comparative effectiveness study: Not mentioned.
• Standalone algorithm performance: Not applicable as this is a physical medical device, not an AI algorithm.
• Type of ground truth: Not mentioned, although for a physical device like a sling, "ground truth" would likely relate to clinical outcomes, physiological measurements, or imaging post-implantation, none of which are detailed here.
• Sample size for training set: Not applicable as this is a physical medical device, not an AI algorithm.
• How ground truth for training set was established: Not applicable as this is a physical medical device, not an AI algorithm.

The core of the provided document is the 510(k) regulatory submission, which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed scientific study report.

Ask a specific question about this device

The AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

The AMS Pelvic Floor Repair System consists of needles and mesh used to repair the pelvic floor.

The provided text is a 510(k) summary for the AMS Pelvic Floor Repair System. Unfortunately, it does not contain the detailed information required to answer your specific questions about acceptance criteria, device performance results, sample sizes, expert qualifications, or ground truth establishment.

The "Summary of Testing" section is very brief, stating only: "The components of the AMS Pelvic Floor Repair System have been tested for The oumponents of the fine ince requirements and found to be substantially equivalent to the predicate devices."

This highlights a common characteristic of 510(k) summaries, which often focus on demonstrating substantial equivalence to a predicate device rather than providing extensive details about de novo performance studies against specific acceptance criteria. For devices cleared through the 510(k) process, the primary "acceptance criterion" is usually a finding of substantial equivalence to a legally marketed predicate.

Therefore, many of your questions cannot be answered from the provided document. Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Study Information (Based on the Provided Text)

Reported Device Performance: The document states: "The components of the AMS Pelvic Floor Repair System have been tested for The oumponents of the fine ince requirements and found to be substantially equivalent to the predicate devices." No specific performance metrics (e.g., sensitivity, specificity, accuracy, mechanical strength, biocompatibility results) are provided or compared against acceptance criteria. |
| 2. Sample Size for Test Set & Data Provenance | Not provided. The summary just generally mentions "testing" without detailing the nature of the tests (e.g., clinical, bench, animal) or the sample sizes involved. |
| 3. Number of Experts & Qualifications for Ground Truth | Not applicable/provided. This device is a surgical mesh; the "ground truth" would typically refer to clinical outcomes, mechanical properties, or biocompatibility, not expert interpretation of diagnostic images. |
| 4. Adjudication Method | Not applicable/provided. |
| 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study | No. This device is a surgical mesh, not an AI-assisted diagnostic tool. |
| 6. Standalone Performance Study (Algorithm Only) | No. This device is a surgical mesh, not an algorithm. Performance would relate to its physical and biological properties. |
| 7. Type of Ground Truth Used | Not explicitly stated. For a surgical mesh, "ground truth" would likely involve:

• Bench testing results: Mechanical strength, pore size, material composition, etc.
• Biocompatibility testing: In vitro and/or in vivo studies.
• Animal studies: To assess in-vivo performance and host response.
• Clinical outcomes: From studies on the predicate devices or potentially early clinical use if available (though not detailed here). |
  | 8. Sample Size for Training Set | Not applicable/provided. This is not a machine learning device. |
  | 9. How Ground Truth for Training Set Was Established | Not applicable/provided. |

Ask a specific question about this device