(282 days)
The SURELIFT PROLAPSE SYSTEM is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and posterior vaginal wall prolapse. The kit includes instrumentation for transvaginal placement.
The Surelift Prolapse System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and posterior vaginal wall prolapse. The kit includes instrumentation for transvaginal placement.
The kit is composed by a monofilament polypropylene mesh, two anchors with sutures to fix the mesh at the sacrospinose ligament, two anchoring handles to place the anchors and four passers to place the mesh through the obturator foramens.
The mesh has six fixation points (two posterior fixation points and four arms):
- Two posterior fixation points that are fixed to the sacrospinose ligaments.
- Two middle arms that are passed through the arcus tendineus.
- Two anterior arms that are passed through the anterior part of the obturator foramen.
When placing the mesh, these six fixation points can be adjusted by the surgeon to leave the mesh flat at the proper tension avoiding wrinkles.
Here's a breakdown of the acceptance criteria and study information for the Surelift Prolapse System, based on the provided 510(k) amendment:
1. Table of Acceptance Criteria and Reported Device Performance
It's important to note that this 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices rather than proving specific clinical safety and effectiveness through a dedicated clinical performance study with detailed acceptance criteria measured against clinical outcomes. The "performance tests" listed are primarily related to material properties, sterilization, and biocompatibility, ensuring the device meets established standards for medical devices of its type.
| Acceptance Criteria Category | Specific Test/Property | Reported Device Performance |
|---|---|---|
| Material Properties | Monofilament diameter (mesh) | 0.12 mm |
| Tensile break strength (mesh) | 81.87 Newton | |
| Pore size (mesh) | 1.12 mm | |
| Thickness (mesh) | 0.41 mm | |
| Density (mesh) | 41.60 g/m² | |
| Porosity (mesh) | 54.63 % | |
| Suture size | USP 0 | |
| Anchor diameter | 3 mm | |
| Anchor length | 7 mm | |
| Anchoring Handle tube diameter | 6 mm | |
| Anchoring Handle tube length | 204 mm | |
| Passers diameter | 4 mm | |
| Mechanical Strength | Suture pullout strength | Meets established performance requirements and standards |
| Tensile break strength at break | Meets established performance requirements and standards | |
| Tear resistance | Meets established performance requirements and standards | |
| Burst strength | Meets established performance requirements and standards | |
| Stiffness | Meets established performance requirements and standards | |
| Prolapse anchor-mesh strength | Meets established performance requirements and standards | |
| Prolapse arm tensile strength | Meets established performance requirements and standards | |
| Sterilization | Bioburden | Meets established performance requirements (sterilized by ETO) |
| Ethylene oxide residuals | Meets established performance requirements and standards | |
| Ethylene chlorohydrins residuals | Meets established performance requirements and standards | |
| Sterility assurance level (SAL) determination | Meets established performance requirements and standards | |
| Packaging | Expiration dating test | Meets established performance requirements and standards |
| Biocompatibility | Cytotoxicity | Meets established performance requirements and standards |
| Implantation | Meets established performance requirements and standards | |
| Sensitization with polar and non-polar extract | Meets established performance requirements and standards | |
| Genotoxicity | Meets established performance requirements and standards | |
| Acute systemic toxicity | Meets established performance requirements and standards | |
| Irritation | Meets established performance requirements and standards | |
| Haemolysis | Meets established performance requirements and standards | |
| Extractable metallic ions | Meets established performance requirements and standards | |
| Pyrogen test | Meets established performance requirements and standards |
Study that Proves Device Meets Acceptance Criteria:
The document describes a series of "Performance tests" that were conducted to demonstrate the device meets established performance requirements and standards.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify sample sizes for any of the individual performance tests (e.g., number of meshes tested for tensile strength, number of anchors for pullout strength). It also doesn't mention data provenance regarding country of origin or whether the data was retrospective or prospective. These types of tests are typically conducted in a laboratory setting using manufactured samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable in this context. The "performance tests" relate to physical, chemical, and biological properties, not clinical diagnostic accuracy or interpretation requiring expert consensus on a test set. The ground truth for these tests is based on objective measurements and adherence to recognized standards.
4. Adjudication Method for the Test Set:
This information is not applicable. The performance tests are objective measurements, not subjective evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The submission is for a surgical implant (Surelift Prolapse System), not an AI-assisted diagnostic tool. Therefore, there is no mention of human readers or AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
No, a standalone performance study in the context of an algorithm's performance was not done. This device is a surgical mesh kit, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for the performance tests described is based on:
- Objective measurements: For physical properties like dimensions, tensile strength, pore size, etc.
- Established standards and regulations: For sterilization (e.g., SAL), biocompatibility (e.g., ISO standards for cytotoxicity, irritation), and other performance requirements.
8. Sample Size for the Training Set:
This information is not applicable. The device is a surgical mesh kit, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no training set for this device.
§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.