(77 days)
The MiniArc Precise™ 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 MiniArc Precise Single-Incision Sling System (MiniArc Precise) is a modification of the currently commercialized device, MiniArc Single-Incision Sling System (MiniArc), which consist of one sterile mesh sling and one sterile surgical instrument · used for sub-urethral sling placement. The minor modifications to MiniArc for the development of the MiniArc Precise are as follows: Self-fixating tips on the mesh sling are for a "secure connection" (snap-fit) to 0 the delivery tool needle tip. Delivery tool has an actuating needle tip release mechanism for the mesh sling. ● Mesh slings center-length dimensions are modified and the mesh sling arms 0 are knit with reinforcement fibers. The MiniArc Precise is available in two configurations; each configuration contains one sterile mesh sling and one sterile delivery tool. The identical delivery tool is used with both configurations. The configurations are identified by the mesh sling option, either the short center-length mesh or the long center-length mesh. The mesh sling and mesh arms material for MiniAre Precise is the same knitted polypropylene monofilament material used in the predicate, MiniArc. MiniArc Precise uses the same surgical approach and the same mesh placement procedures as the predicate device. MiniArc. The MiniArc Precise device is for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). MiniArc Precise device is for single use only and is not to be re-sterilized.
The provided text describes a 510(k) premarket notification for a medical device called the MiniArc Precise™ Single-Incision Sling System. This submission focuses on demonstrating substantial equivalence to a predicate device (MiniArc® Sling System) rather than presenting a de novo study with acceptance criteria in the traditional sense of a performance study.
Therefore, the information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as typically found in AI/diagnostic device submissions, is not applicable here.
This submission relies on non-clinical testing to show that the minor modifications to the MiniArc Precise device do not change its fundamental scientific technology, intended use, or product performance specifications compared to the predicate device.
Here's an breakdown of the information that is available based on your request, with an emphasis on what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Type |
|---|---|---|
| Equivalence to Predicate Device for Intended Use | Confirmed product performance suitable for intended use, which is the same as the predicate device. | Bench testing |
| Tissue Fixation and Tissue Response | Confirmed equivalence to the predicate device. | Animal testing |
| Surgical Procedure (using "secure connection" self-fixating tips) | Confirmed equivalence to the predicate device. | Cadaver lab testing |
| Biocompatibility | Ensured biocompatibility based on similarity of materials to the predicate device. | Biocompatibility assessment |
| Design Verification | Adherence to Quality System Requirements (FDA 21 CFR Part 820.20, EN ISO 13485:2003); Design Controls (FDA 21 CFR Part 820.30). | Non-clinical testing |
| Device Performance | Adherence to Quality System Requirements (FDA 21 CFR Part 820.20, EN ISO 13485:2003); Design Controls (FDA 21 CFR Part 820.30). | Non-clinical testing |
| Packaging | Adherence to ISO 11607:2006 Part 1 & 2. | Non-clinical testing |
| Shelf Life | Adherence to ISO 11607:2006 Part 1, 6.4 Stability Testing. | Non-clinical testing |
| Sterilization | Adherence to ISO 11135 and EN ISO 13485. | Non-clinical testing |
Explanation: The "acceptance criteria" here are effectively the demonstrations of equivalence or adherence to standards, rather than specific performance metrics like sensitivity/specificity for a diagnostic device. The "reported device performance" is a confirmation that these criteria were met.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as a numerical sample size for human subjects or data sets in the context of device performance testing. The "test sets" refer to the subjects/materials used in bench testing, animal testing, and cadaver lab testing.
- Data Provenance:
- Bench testing: In-house laboratory testing (implied).
- Animal testing: Performed as per FDA 21 CRR: Part 58 Good Laboratory Practice Regulations (location not specified, but typically conducted in regulated lab environments).
- Cadaver lab testing: Performed using human cadavers (location not specified).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This submission does not involve a diagnostic AI algorithm or a study requiring expert readers to establish ground truth for a test set. The validation is based on engineering principles, material science, and biological response assessments (animal/cadaver models) to demonstrate physical and functional equivalence to a predicate device.
4. Adjudication method for the test set
- Not Applicable. As there are no expert readers establishing ground truth for a test set in statistical terms (e.g., image interpretation), no adjudication method is relevant.
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 submission is for a surgical implant (suburethral sling system), not a diagnostic device assisted by AI. Therefore, an MRMC study or AI assistance effect size is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware medical device (surgical sling) and does not involve any algorithms or AI for standalone performance.
7. The type of ground truth used
- For bench testing: Engineering specifications and performance standards.
- For animal testing: Histopathological and physiological assessment of tissue response and fixation.
- For cadaver lab testing: Observational assessment of surgical procedure and device placement/fixation, likely by surgeons/medical professionals.
8. The sample size for the training set
- Not Applicable. This submission does not involve machine learning or AI, and therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.