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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. |

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BioArc TO Subfascial Hammock is intended for the placement of a suburethral graft for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and / or intrinsic sphincter deficiency.

The BioArc SP Sling Kit is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and / or intrinsic sphincter deficiency.

The BioArc TO Subfascial Hammock is a suburethral sling procedure that uses a transobturator surgical approach to treat stress urinary incontinence. It is a sterile, single transobare kit consisting of two stainless steel helical shaped needle passers and a mesh sling assembly to which graft material is attached.

The provided text is a 510(k) summary for the BioArc TO™ Subfascial Hammock. It describes the device, its indications for use, and its comparison to predicate devices, ultimately concluding substantial equivalence. However, the document explicitly states that it is a Special 510(k) application and that "the risk analysis and the verification / validation activities reported in this Special 510(k) application substantiate equivalence to the predicate devices and did not raise any new questions of safety or efficacy." This means that a full clinical study with specific acceptance criteria and detailed performance reporting, as you've requested, was not conducted or reported in this specific submission for the BioArc TO device.

Instead, the submission relies on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices (BioArc SP™ Sling Kit and MONARC™ subfascial hammock) based on similar indications for use, fundamental scientific technology, surgical approach, sling placement, and materials.

Therefore, I cannot provide the detailed information you requested about acceptance criteria and study data for the BioArc TO device from this document. The information you are asking for typically comes from a full clinical trial or a more extensive performance study, which is not summarized here for a Special 510(k) such as this.

If the BioArc SP Sling Kit is considered a predicate, the "Indications For Use" statement from page 3, which is for the BioArc SP Sling Kit alone, would be relevant to understand the clinical context for which the predicate (and by extension the new device) is intended.

Since the document does not present a standalone study with acceptance criteria and a performance table for the BioArc TO, I will state that such information is not available in the provided text.

Information Not Available in the Provided Text:

1. A table of acceptance criteria and the reported device performance: This information is not provided because the submission relies on substantial equivalence to predicate devices, rather than presenting a de novo performance study for the BioArc TO.
2. Sample size used for the test set and the data provenance: No new test set data is presented for the BioArc TO device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no new test set data is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is a surgical mesh, not an AI or imaging device. Therefore, an MRMC study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no new clinical performance data is presented.
8. The sample size for the training set: Not applicable, as no algorithm or AI is involved.
9. How the ground truth for the training set was established: Not applicable, as no algorithm or AI is involved.

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