(96 days)
MiniSling™- Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System is an implant device that is intended for the treatment of Stress Urinary Incontinence (SUI ) resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissue where weakness exists in the Urological, Gynecological, Uro-Gynecological or Gastroenterological anatomy. This includes but not limited to the following procedures: Pub urethral support, and Bladder support, Urethral and Vaginal Prolapse Repair, Colon and Rectal Prolapse Repair, Reconstruction of Pelvic floor and Sacral Colposuspension.
The MiniSling™- Adjustable Polymer Sling & Surgical Mesh with Modular Anchor System is available with Single use, universal introducer device with notched tip design, compatible with Fixed, Adjustable and Snap-On modular self anchoring fixation ends of urethral sling and surgical mesh. The Introducer tip can be attached to slot in the fixation anchor for quick connect & disconnect for easy delivery of urethral sling and surgical mesh into target soft tissue. The position of Fixation anchors and sling can also be adjusted intra-operatively using introducer. The T anchors and Split anchors can be delivered in to soft tissue using, modified needle device with ease and minimum discomfort to the patient. The introducer device is available in straight, curved malleable and detachable configuration in various length and curvature to meet physician's preference, patient's anatomy & surgical procedure requirements.
The provided text details a 510(k) summary for the MiniSling™ device. It describes the device, its intended use, and compares its technological characteristics to predicate devices. However, the document does not contain a comprehensive study proving the device meets specific acceptance criteria in the format typically associated with a clinical trial or a detailed performance validation report. Instead, it relies on preclinical testing and comparison to legally marketed predicate devices for substantial equivalence.
Here's a breakdown of the information that can be extracted from the provided 510(k) summary, structured to address your request as much as possible, while also highlighting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Expected Performance) | Reported Device Performance |
|---|---|
| Device performs as intended when used according to instructions. | "Laboratory product testing has indicated that the urethral Sling and Surgical mesh devices has demonstrated satisfactory performance for its intended applications." |
| Tensile strength and breakage force are satisfactory for intended use. | "Mechanical testing of the devices also demonstrated that the tensile strength and breakage force are equal or more than the predicated devices and are satisfactory for its intended use." |
| Pull force of tissue fixation anchor. | "The average pull force of tissue fixation anchor is more than 4000 Gms, during initial implantation stage." |
Important Note: The provided document states that "Preclinical testing was performed," but it does not specify what the quantitative acceptance criteria for "satisfactory performance," "tensile strength," or "breakage force" were. It only states that the device met these unquantified criteria and that the tensile strength and breakage force were "equal or more than the predicated devices."
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the preclinical testing. Therefore, the data provenance (e.g., country of origin, retrospective/prospective) cannot be determined from this text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the 510(k) summary. The preclinical testing described appears to be laboratory-based mechanical testing, not a study involving expert assessment or clinical ground truth establishment in the typical sense.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The testing described is preclinical mechanical testing, not a study requiring adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document focuses on preclinical mechanical testing and comparison to predicate devices, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This is not applicable and not mentioned. The device is a physical surgical implant, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the preclinical testing described is based on predefined mechanical and performance parameters (e.g., tensile strength, breakage force, pull force) measured in a laboratory setting. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this safety and effectiveness summary.
8. Sample Size for the Training Set
This information is not applicable and not provided. As this is a physical device, not an algorithm or AI system, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, for the same reasons as above.
§ 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.