(86 days)
The RetroArc™ Retropubic Sling System is intended for the placement of a suburethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
The RetroArc System is a sterile, single use system, consisting of one plastic handle, two stainless steel delivery needles and a sling assembly. The tip portion of each delivery needle is configured to allow for passage through tissue. The opposite end of the needle is configured to connect with the plastic handle. The handle is detachable and is used to direct both delivery needles through tissue. The sling assembly includes one piece of loosely knitted polypropylene mesh with an integrated adjustment suture, two removable plastic insertion sheaths, and two connectors attached to the insertion sheaths. The adjustment suture is an integral feature woven into the mesh which limits the overall stretch of the mesh arms during the procedure. The integrated suture and mesh, allow for adjustment of the sling after initial placement in the patient without the use of additional tools. The two plastic sheaths overlap during placement and allow for convenient travel of the sling through the tissue. The connectors, sheaths, and delivery instruments are used to facilitate placement of the mesh assembly, and are not implanted. The mesh component is not absorbed by the action of tissue in-growth or tissue enzymes
Here's an analysis of the provided information regarding the RetroArc™ Retropubic Sling System, focusing on acceptance criteria and supporting studies:
Summary of Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Test/Requirement | Reported Device Performance |
|---|---|---|
| Material/Processing | Sterilization | Successfully completed |
| Shelf Life | Successfully completed | |
| Biocompatibility | Successfully completed | |
| Delivery Instrument | Delivery Instrument Torsional Strength | Successfully completed (meets product specification and performance requirements) |
| Needle Connection Cycling | Successfully completed (meets product specification and performance requirements) | |
| Needle Connection Push Force | Successfully completed (meets product specification and performance requirements) | |
| Needle Disconnection Pull Force | Successfully completed (meets product specification and performance requirements) | |
| Needle Disconnection Button Force | Successfully completed (meets product specification and performance requirements) | |
| Human Factors/Usability | Physician Questionnaire (cadaver evaluation) | Successfully completed |
| Cadaver Evaluation | Successfully completed | |
| Cadaver Dissection | Successfully completed | |
| Effectiveness (Clinical) | Treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD) | Not directly assessed through clinical trials for this device; reliance on substantial equivalence to predicate. |
Study Details
This submission does not describe a study to prove the device meets specific acceptance criteria in terms of clinical efficacy or diagnostic accuracy for an AI/CADe device. Instead, it describes non-clinical testing to demonstrate the substantial equivalence of a medical device (a surgical sling system) to a predicate device.
Here's the breakdown based on the request, adapted for the provided information:
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A table of acceptance criteria and the reported device performance:
(See table above) -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set (for non-clinical performance and cadaver studies): The document does not specify exact sample sizes for the bench tests (e.g., how many instruments were tested for torsional strength). For the cadaver studies, the sample size is also not explicitly stated (e.g., "Physician Questionnaire," "Cadaver Evaluation," "Cadaver Dissection" imply a limited number of cadavers and physicians, but no numbers are provided).
- Data Provenance: Not specified beyond being "bench testing" and "cadaver testing." No country of origin is mentioned. These are non-clinical studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- For Bench Testing: "Bench testing was performed to support this submission." The experts here would be the engineers/technicians performing the tests and comparing results to product specifications. Their number and qualifications are not provided.
- For Cadaver Testing: "Physician Questionnaire," "Cadaver Evaluation," "Cadaver Dissection." These imply physician involvement. The number of physicians and their qualifications are not provided. They would be establishing a "ground truth" on the usability and handling of the device in a cadaveric setting, not a clinical outcome.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No adjudication method is described. The non-clinical tests likely followed standard engineering validation protocols. The cadaver evaluation seems to involve direct assessment, but no multi-reader/adjudication process is mentioned.
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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:
- No MRMC study was done. This document is for a surgical sling system, not an AI/CADe device. Therefore, the concept of human readers improving with AI assistance is not applicable.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone (algorithm only) performance study was done. This is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Bench Testing: The ground truth is based on predefined product specifications and engineering requirements.
- For Cadaver Testing: The ground truth seems to be an assessment of device handling, placement, and anatomical interaction by physicians in a simulated environment (cadavers). This would be a form of expert assessment of physical performance, not clinical outcomes.
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The sample size for the training set:
- Not applicable. This device is a physical surgical implant and delivery system, not an AI model requiring a training set.
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How the ground truth for the training set was established:
- Not applicable. This device does not use a training set as it is not an AI model.
Conclusion:
The K132655 submission for the RetroArc™ Retropubic Sling System does not involve AI or CADe technology. Therefore, many of the requested details regarding AI-specific studies (MRMC, standalone performance, training sets, ground truth for AI models) are not applicable.
The submission focuses on establishing substantial equivalence to a predicate device (SPARC® Sling System K081613) through non-clinical bench testing and cadaver studies. The acceptance criteria are primarily related to the mechanical performance of the delivery instruments and the usability in a cadaveric setting, demonstrating that the design modifications (primarily to the delivery instruments) do not negatively impact the fundamental performance or safety compared to the predicate device. No clinical testing was performed for this submission. The "ground truth" for the non-clinical tests was established by meeting engineering specifications and by qualitative assessment during cadaveric evaluation.
§ 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.