(20 days)
The Mentor Aris Suprapubic Surgical Kit is indicated for the surgical treatment of all types of stress urinary incontinence (SUI), and for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The Mentor Aris Suprapubic Surgical Kit consists of two components: the Mentor Aris Sling and a set of Introducers. The Mentor Aris Sling is an implantable, suburcthral, support tape made from knitted monofilament polypropylene fibers. Two sterile, disposable flat curved Introducers necessary for implantation of the sling are also included in the Surgical Kit. The Introducers consist of a stainless steel needle with a plastic handle.
The Mentor Aris™ Suprapubic Surgical Kit is a medical device for the surgical treatment of stress urinary incontinence. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a standalone study report.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Aris Sling Biocompatibility: Non-toxic, non-irritant | Demonstrated to be biocompatible under 510(k) K050148 (pre-cleared). |
| Aris Introducers Cytotoxicity (ISO 10993-5): Non-toxic | Results demonstrate the Introducers are non-toxic. |
| Aris Introducers Intracutaneous Reactivity (ISO 10993-10): Non-irritant | Results demonstrate the Introducers are non-irritants. |
| Aris Introducers Sling Pull-Out Force from Eyelet: Meets required specifications | Results demonstrate the Aris Introducers meet the required performance characteristic specifications for the intended use of the instruments. |
| Aris Introducers Torque and Tensile Performance of Handle/Needle Interface: Meets required specifications | Results demonstrate the Aris Introducers meet the required performance characteristic specifications for the intended use of the instruments. |
| Aris Introducers Needle Flexure Characterization: Meets required specifications | Results demonstrate the Aris Introducers meet the required performance characteristic specifications for the intended use of the instruments. |
| Aris Introducers Needle Stiffness Characterization: Meets required specifications | Results demonstrate the Aris Introducers meet the required performance characteristic specifications for the intended use of the instruments. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific sample sizes for the testing described for the Aris Introducers. It generally states that "testing was performed."
The data provenance is not explicitly mentioned but typically in 510(k) submissions, testing is performed by the manufacturer or contracted labs. The studies listed are laboratory-based performance and biocompatibility tests, not clinical studies with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The "ground truth" here refers to established standards (e.g., ISO guidelines for biocompatibility, engineering specifications for mechanical performance), not expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like "2+1" are relevant for clinical studies or evaluations involving human interpretation. The testing described is objective laboratory testing against predetermined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The device is a surgical kit, not an AI software or diagnostic tool that would involve human readers or image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical surgical kit, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for the testing described is based on:
- International Standards: Specifically, ISO 10993-5 (cytotoxicity) and ISO 10993-10 (intracutaneous reactivity) for biocompatibility.
- Engineering Specifications/Performance Characteristic Specifications: For the mechanical and physical properties of the Introducers (e.g., sling pull-out force, torque, tensile performance, flexure, stiffness). These specifications are set by the manufacturer to ensure the device performs as intended.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for this device.
Overall Study Information:
The "study" presented in this 510(k) summary is a set of tests designed to demonstrate that the Mentor Aris Suprapubic Surgical Kit (specifically the Introducers, as the Sling was previously cleared) meets established safety and performance requirements and is substantially equivalent to predicate devices. These tests include:
- Biocompatibility Testing of Aris Introducers: Cytotoxicity per ISO 10993-5 and intracutaneous reactivity per ISO 10993-10. These tests determine if the device materials are harmful to biological systems.
- Performance Testing of Aris Introducers: This involved evaluating the mechanical integrity and functionality of the Introducers, including:
- Sling pull-out force from the eyelet
- Torque and tensile performance of the handle/needle interface
- Needle flexure characterization
- Needle stiffness characterization
The results of these tests confirmed the Introducers are "non-toxic and non-irritants" and "meet the required performance characteristic specifications for the intended use of the instruments," supporting the claim of substantial equivalence. The document does not provide raw data, specific numerical thresholds for "acceptance criteria," or detailed test methodologies beyond the standard names mentioned.
§ 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.