(95 days)
The MiniArc® Pro Single-Incision Sling System is intended for the placement of a sub-urethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
The MiniAre Pro Sling System is designed to treat female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The sling is comprised of a piece of polypropylene monofilament mesh with polypropylene self-fixating tips (anchors), a mid-line mark, and elongation feedback system. The elongation feedback system is attached to the sling intraoperative adjustment/tensioning and allows for objective measurement of sling elongation during the implant procedure. The sling is intended to remain in the body as a permanent implant with the polypropylene self-fixating tips providing short-term fixation prior to tissue in-growth. The elongation feedback system is intended to be removed prior to closure of the vaginal incision. The delivery tool (needle) is designed to interface with the self-fixating tips and deliver it to the obturator internus muscle, retaining the self-fixating tip until it is selectively released by the physician.
The provided 510(k) summary for the MiniArc® Pro Single-Incision Sling System does not detail specific acceptance criteria or a study proving that the device meets those criteria in the traditional sense of a clinical trial for a novel AI or diagnostic device. Instead, this submission is for a medical device that is demonstrated to be substantially equivalent to a predicate device already on the market.
Therefore, the "acceptance criteria" here refers to the criteria used to establish substantial equivalence with the predicate device, and the "study" is the non-clinical testing performed to show that the new device meets its own product specifications and performance requirements, which are comparable to the predicate device.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Indications for Use: Identical to predicate device | "The MiniArc Pro Single-Incision Sling System is intended for the placement of a sub-urethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD)." - Identical to Predicate K100807. |
| Fundamental Scientific Technology: Identical to predicate device | "Self fixation urethral mesh sling" - Identical to Predicate K100807. |
| Material Composition (Mesh, Self-Fixating Tip): Identical to predicate device | "Polypropylene, Type I monofilament" for both mesh and self-fixating tip. - Identical to Predicate K100807. |
| Design Characteristics (Midline Mark, Delivery Tool Handle/Needle, Procedure): Highly similar to predicate device | Midline Mark: "Printed, Blue". Delivery Tool Handle: "Polycarbonate with over-mold". Delivery Tool Needle: "Stainless Steel with molded barb guards". Procedure: "Transobturator-like approach". - Identical to Predicate K100807. |
| Packaging Materials/Configuration: Identical to predicate device | "PETG tray and Tyvek lid", "Single sterile barrier configuration". - Identical to Predicate K100807. |
| Sterilization Method/Sterility Assurance Level (SAL): Identical to predicate device | "EO with SAL > 10^-6". - Identical to Predicate K100807. |
| Product Specifications and Performance Requirements (Bench Testing): Meets specified performance. | Successfully completed: Sterilization, Shelf Life, Biocompatibility, Performance Testing (Bench: Feedback System Repeatability, Attachment, Dimensional, Removal Force, Stiffness), Performance Testing (Cadaver: Physician Questionnaire, Cadaver Evaluation). - Results demonstrate compliance with product specifications and performance requirements. |
Study Details
Given this is a 510(k) for substantial equivalence to a predicate device, the "study" is primarily a non-clinical assessment rather than a traditional clinical trial.
-
Sample size used for the test set and the data provenance:
- Test Set (Non-Clinical): Not explicitly stated in terms of specific numbers for each test, but categories of testing are listed.
- Bench Testing: Conducted to assess characteristics like "Feedback System Repeatability," "Feedback System Attachment," "Feedback System Dimensional," "Feedback System Removal Force," and "Feedback System Stiffness." The exact number of samples for each of these tests is not provided in the summary.
- Cadaver Testing: Performed for "Physician Questionnaire" and "Cadaver Evaluation." The number of cadavers or physicians involved is not specified.
- Data Provenance: The testing was conducted internally or by contracted labs as part of the device development and submission process. The country of origin is implicitly the United States, given the submitter is American Medical Systems located in Minnetonka, MN, and the submission is to the FDA. The tests are retrospective in the sense that they were completed prior to the 510(k) submission.
- Test Set (Non-Clinical): Not explicitly stated in terms of specific numbers for each test, but categories of testing are listed.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cadaver Performance Testing: A "Physician Questionnaire" and "Cadaver Evaluation" were performed. This implies medical experts (physicians) were involved in evaluating the device's performance in a cadaveric setting. The exact number and their qualifications (e.g., years of experience, specialty) are not specified in the summary.
-
Adjudication method for the test set:
- For the non-clinical tests, the adjudication method is typically predefined pass/fail criteria for each test (e.g., within a specified range for dimensional, sufficient removal force). No specific adjudication method like "2+1" or "3+1" (common in human-reader studies) is described, as it's not applicable to bench or cadaver testing of device mechanics.
-
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. This is a medical device (surgical sling system), not an AI or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable here. The device's performance is intrinsically linked to its physical properties and intended use by a surgeon.
-
The type of ground truth used:
- For Bench Testing: The ground truth is engineering specifications, validated test methods, and predefined acceptance criteria (e.g., material properties, dimensional tolerances, force measurements). These are objective and measurable.
- For Cadaver Performance Testing: The ground truth would be based on expert opinion and observations from qualified physicians regarding the ease of use, deployment, and overall performance of the device in a simulated anatomical environment (cadaver).
-
The sample size for the training set:
- Not applicable. This is a physical medical device, not an algorithm that requires a "training set" in the context of machine learning.
-
How the ground truth for the training set was established:
- Not applicable. As a physical medical device, there is no "training set" or corresponding ground truth establishment in this context.
§ 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.