(80 days)
The Mentor SUSPEND™ Sling is an implant which is intended to reinforce soft tissue where weakness exists in the urological and vastigal and vaginal tissue where weakless casis in the and bladder support, urethral and vaginal procedures: pubburential support and elsesses and sacro-colposuspension. It is intended for the treatment of female urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
The Mentor SUSPEND™ Sling is rectangular in shape and will be made available in several sizes: 2 cm x 4 cm, 3 cm x 5 cm, and 4 cm x 7 cm to accomodate various patient profiles. An aperature matrix is incorporated throughout the device. The Mentor SUSPEND™ Sling is manufactured from a biocompatible, segmented polyether urea urethane elastomer. An anti-bacterial coating has been incorporated onto the surface of the device.
This document is a 510(k) summary for the Mentor SUSPEND™ Sling, a surgical mesh intended to reinforce soft tissue in various urological and vaginal procedures, including the treatment of female urinary incontinence.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | The material used in the Mentor SUSPEND™ Sling has been tested for biocompatibility and passed all tests. |
| Suture Pull Strength (Design Criteria) | The test results showed that the Mentor SUSPEND™ Sling met the design criteria for suture pull strength. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify the sample size used for the biocompatibility or suture pull strength tests. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not mention human expert involvement in establishing ground truth for the device's performance in the described tests. The tests performed are material property tests (biocompatibility and suture pull strength), which typically rely on standardized laboratory protocols rather than expert consensus on observational data.
4. Adjudication Method:
Given that the tests described are laboratory-based material property tests, an adjudication method for a test set (like 2+1 or 3+1 for clinical observations) is not applicable and is not mentioned in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as per the provided information. The study described focuses on material properties rather than diagnostic or treatment effectiveness in a clinical setting involving human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a medical implant, not an algorithm or AI system. Therefore, "standalone algorithm performance" is not relevant.
7. Type of Ground Truth Used:
The ground truth for the reported tests was based on laboratory standards and pre-defined design criteria.
- For biocompatibility: Adherence to established biocompatibility test standards.
- For suture pull strength: Meeting the internal "design criteria" for this specific mechanical property.
8. Sample Size for the Training Set:
This concept is not applicable. The device is a physical implant, not a machine learning model. There is no "training set" in the context of material property testing of this type.
9. How the Ground Truth for the Training Set Was Established:
This concept is not applicable as there is no training set for this type of device.
§ 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.