Search Results

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 PFR Sling System is a sterile, single use procedure kit that consists of stainless steel, curved needle passers and an implantable mesh assembly.

The provided text describes a 510(k) summary for the "PFR Sling System, Part of the AMS Pelvic Floor Repair System," which is a surgical mesh. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical or performance study with a device output.

Therefore, the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies cannot be extracted from the provided text.

The document states:

• "The components of the PFR Sling System have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices." (Page 1, under "Summary of Testing")

This indicates that a comparison was made against existing, legally marketed devices. However, the details of what "performance requirements" were and how "substantial equivalence" was demonstrated in terms of specific metrics, acceptance criteria, or a detailed study are not included in this summary.

In summary, the provided document does not contain the information necessary to fulfill the request as it describes a regulatory submission based on substantial equivalence, not a detailed performance study with quantifiable acceptance criteria and device performance metrics.

Ask a specific question about this device

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 Apogee and Perigee Systems with IntePro Lite and InteXen LP are sterile, single use procedure kits that consist of stainless steel, curved needle passers and an implantable mesh assembly.

The provided text is a 510(k) summary statement and related FDA correspondence for a surgical mesh device. The document states that the device components were "tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices." However, it does not provide specific quantitative acceptance criteria or a detailed study description that proves the device meets those criteria.

Therefore, the requested information, which typically involves detailed performance metrics, sample sizes, expert involvement, and ground truth establishment, is not present in the provided text.

Here's a breakdown of why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: The document states "tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices." It does not provide a table with specific criteria (e.g., tensile strength, pore size, elasticity) or the numerical results from these tests.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. The testing described is for biocompatibility and performance, not involving human interpretation of medical data where experts would establish ground truth.
4. Adjudication method for the test set: Not applicable for the type of testing described (biocompatibility and performance).
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 about a surgical mesh, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical device.
7. The type of ground truth used: Not applicable in the context of the described physical device testing. The "ground truth" for material properties would be the established standards or values of the predicate device.
8. The sample size for the training set: Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable. This is not a machine learning device.

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