(87 days)
The GYNECARE TVT ABBREVO™ Continence System is intended to be used in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
GYNECARE TVT ABBREVO™ device is a sterile, single-patient use device which consists of one piece of blue (phtalocyanine blue, color index number 74160) PROLENE™ polypropylene mesh (mesh implant) approximately 1.1 cm x 12 cm covered by a polyethylene sheath.
The Helical Passer Sheaths (white polyethylene tube receptacles) are attached along with the mesh implant sheath by PROLENE polypropylene Positioning Lines to each end of the mesh implant to accommodate the Helical Passers. The Helical Passers come assembled to the GYNECARE TVT ABBREVO™ device and are used to deliver the mesh implant via the trans-obturator 'inside-out" approach.. Further, there is a GYNECARE TVT ABBREVO™ Placement Loop consisting of a loop of PROLENE Polypropylene Monofilament with an attached polypropylene button, pre-assembled as part of the GYNECARE TVT ABBREVO™ Implant Assembly at the center of the mesh to aid in symmetric placement of the mesh.
This document describes the GYNECARE TVT ABBREVO™ Continence System, a surgical mesh device for treating stress urinary incontinence (SUI) in women. Based on the provided text, here's a breakdown of the acceptance criteria and the study information:
Key Observation:
The provided document is a 510(k) submission summary for the GYNECARE TVT ABBREVO™ Continence System. The purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device, not necessarily to perform a full clinical trial to establish new safety and effectiveness claims from scratch (unless specific performance data is required to establish substantial equivalence for a novel aspect). Therefore, the study described is focused on demonstrating equivalence and device performance, rather than clinical efficacy studies often associated with AI/software devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results in the format often seen for AI/software-based medical devices (e.g., sensitivity, specificity thresholds). Instead, safety and performance were evaluated through a series of tests to demonstrate the device fulfills predefined user specifications and functions as intended, supporting its substantial equivalence to predicate devices.
| Acceptance Criteria Category | Reported Device Performance / Evaluation Method |
|---|---|
| Biocompatibility | Tested in accordance with ISO 10993-1 standard recommendations. (Implies compliance with biological safety standards). |
| Physical/Performance Measurements | Benchtop tests including "Length of Positioning Line + Mesh" and "Attachment Strength" were conducted. (Implies meeting predefined physical strength and dimensional specifications, though specific numeric values are not provided). |
| Initial Fixation & Anatomic Pathway | Studied in a cadaver model. (Implies successful deployment and initial stability in a simulated anatomical environment). |
| Tissue In-growth | Studied in an animal model. (Implies suitability for tissue integration, a key aspect of mesh function). |
| Overall Equivalence | Demonstrated to have the same indications for use, principle of operation, and fundamental scientific technology as its predicate device (GYNECARE TVT™ Obturator System). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the benchtop, cadaver, or animal model tests. It only lists the types of tests performed.
- Data Provenance:
- Benchtop tests: Likely conducted in a laboratory setting.
- Cadaver model: Human cadavers (origin not specified, but typically conducted in specialized labs or medical institutions).
- Animal model: Animals (species not specified, but this would be a prospective study on the animal subjects).
- Given the nature of the device (surgical mesh), this is not a data-driven AI study with retrospective or prospective patient data in the typical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For benchtop, cadaver, and animal studies, "ground truth" would generally be established by adherence to protocols, engineering specifications, and established biological/anatomical measures, evaluated by qualified lab personnel, engineers, and potentially veterinarians/surgeons, rather than "experts" in the context of clinical image interpretation or AI model validation.
4. Adjudication Method for the Test Set
This information is not provided and is generally not applicable to the types of studies described (biocompatibility, benchtop, cadaver, animal model testing). Adjudication is more relevant in clinical trials or expert-driven evaluations where there might be disagreement in interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not performed. This type of study is specifically relevant for AI/software devices intended to assist human readers (e.g., radiologists interpreting images). The GYNECARE TVT ABBREVO™ is a physical surgical mesh device, not an AI software.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study in the context of AI algorithms was not done. The device is a physical implant requiring direct surgical placement by a human surgeon.
7. The Type of Ground Truth Used
The "ground truth" for the performance data in this submission would derive from:
- Engineering Specifications: For benchmark physical tests like "Length of Positioning Line + Mesh" and "Attachment Strength."
- Established Biological Standards: For biocompatibility (ISO 10993-1) and tissue in-growth studies.
- Anatomical Accuracy/Feasibility: For cadaver model studies assessing initial fixation and anatomic pathway.
- Predicate Device Performance: The ultimate ground truth for this 510(k) submission is that the new device performs "as safe and effective as the predicate device" based on direct comparison of technological characteristics and the performance data listed above.
8. The Sample Size for the Training Set
This information is not applicable (N/A). The GYNECARE TVT ABBREVO™ is a physical medical device (surgical mesh), not an AI/machine learning algorithm, and therefore does not have a "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established
This information is not applicable (N/A) for the same reasons mentioned in point 8.
§ 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.