(15 days)
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:
- 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.
- Sample size used for the test set and the data provenance: No new test set data is presented for the BioArc TO device.
- 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.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- 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.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no new clinical performance data is presented.
- The sample size for the training set: Not applicable, as no algorithm or AI is involved.
- How the ground truth for the training set was established: Not applicable, as no algorithm or AI is involved.
§ 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.