(53 days)
The SiiS#1 Device is intended to be used as a pubourethral sling for treatment of Stress Urinary Incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Indications (from labeling): The SiiS#1 device is intended to be used as a pubourethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The SiiS#1 Inserter, Sling Locater and Urethral Probe are available and intended to facilitate placement of the SiiS#1 device.
The SiiS#1 Bladder-Neck Suspension Device is a sterile, single-use device intended to be used as a pubourethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting form urethral hypermobility and/or intrinsic sphincter deficiency. The SiiS#1 Bladder-Neck Suspension Device Inserter, and Sling Locator are provided and are intended to facilitate the placement of the SiiS#1 Bladder-Neck Suspension Device.
The SiiS#1 Tissue Suspension Device is a sterile single use device, consisting of one piece of undyed polyester tubular mesh approximately 6 mm diameter x 305 mm long (.250 x 12 inches) with both ends terminating in toggle type tissue anchors. The anchors and part of the mesh are held within a long needle inserter. Attached to the mesh creating a secondary sling is a sliding mesh approximately 80 mm long connected to the longer mesh with sliding locks. The sliding locks are advanced with the sling locator to shorten the length of the sling until desired length is achieved. Polyester tubular mesh is constructed of knitted filaments of extruded polyester strands identical in composition to that used in polyester non-absorbable surgical suture. The material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use.
The SiiS#1 Inserter is provided sterile and single use. The inserter is made of stainless steel with an anodized aluminum handle. The tip of the inserter is constructed to accept the toggle anchors and part of the tubular mesh. The inserter is intended to facilitate the passage of the toggle anchors through the rectus fascia below the abdominal skin.
The SiiS#1 Reusable Sling Locator is provided sterile and single use. The locator is made of polyacetal or equivalent and is intended to facilitate the position of the sliding sling on the longer suspender. It is connected and fixed to the longer suspender and interfaces with the sliding sling adjustment locks.
Acceptance Criteria and Device Performance for SiiS#1 Tissue Suspension System
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pull-out Force | Device has a pull-out force well over the predicate device. | "Cadaver testing has shown that the SiiS#1 has a pull-out force that is well over that of the predicate device." |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: Not explicitly stated in the provided document. However, the study was conducted using cadavers.
- Data Provenance: The study was conducted on cadavers. The country of origin of the data is not specified. It is a retrospective study since it uses cadaveric tissue.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable/Not specified. This study focuses on a biomechanical property (pull-out force) and does not involve expert image interpretation or clinical expert evaluation for ground truth.
4. Adjudication Method for the Test Set
- Not applicable. The "ground truth" for pull-out force in cadaver testing is a direct measurement, not subject to subjective expert interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. The study focuses on the physical performance of the device (pull-out force) on cadavers.
6. Standalone (Algorithm Only) Performance
- Not applicable. This is a medical device (surgical mesh), not an AI algorithm. Therefore, the concept of standalone performance for an algorithm does not apply.
7. Type of Ground Truth Used
- The ground truth used was direct biomechanical measurement of pull-out force, conducted on cadaveric tissue.
8. Sample Size for the Training Set
- Not applicable. Training sets are typically associated with machine learning or AI algorithms. This study involves physical testing of a medical device.
9. How Ground Truth for the Training Set was Established
- Not applicable. As mentioned above, this is not an AI/ML study requiring a training set.
§ 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.