(51 days)
The GYNECARE TVT EXACT™ Continence System is intended to be used as a pubourethral sling for treatment of female Stress Urinany Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The GYNECARE TVT EXACT™ Continence System consists of the following sterile, single-use components: GYNECARE TVT EXACT™ Continence System Trocar and Trocar Sheath / Implant Assembly.
The GYNECARE TVT EXACT™ Continence System Trocar Sheath / Implant Assembly consists of one piece of PROLENE™ Polypropylene Mesh (Implant) approximately 1/2 inch (1.1 cm) wide, 18 inches (45 cm) long, and approximately 0.027 inches (0.7 mm) thick. The implant is covered by a clear plastic Implant Sheath and held between two white Trocar Sheaths , which are bonded to the Implant and Implant Sheath.
The GYNECARE TVT EXACT™ Continence System Trocar consists of the stainless steel Trocar Shaft and the plastic Trocar Handle. The Trocar Shaft is designed to fit inside the white Trocar Sheaths on the GYNECARE TVT EXACT™ Continence System Implant / Trocar Sheath Assembly, and is used to position the GYNECARE TVT EXACT™ Continence System Implant in the patient from a vaginal incision up through the abdominal wall.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance for GYNECARE TVT EXACT™ Continence System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Established performance requirements (for Trocar Assembly Tip Bending Strength Testing) | "Design Verification Testing Results (Trocar Assembly Tip Bending Strength Testing) indicates that modified device meets the established performance requirements." |
| No unintended impact within actual or simulated field use environments (for proposed changes to the device) | "Design Validation outcome confirms that the proposed changes do not have an unintended impact within actual or simulated field use environments in a mover consistent with the Instructions for Use of GYNECARE TVT EXACT™ and the surgeon's usual technique." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing described is "Design Verification Testing" and "Design Validation," which typically involves engineering tests rather than clinical data from human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. The "tests" described are related to the physical and functional aspects of the medical device (trocar assembly tip bending strength and impact of design changes in simulated or actual field use, but not specific for human outcome) and do not involve expert interpretation or ground truth establishment in the traditional sense of diagnostic or AI performance evaluation.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. This is expected given the nature of the design verification and validation tests performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted as described in the provided text. The document focuses on the substantial equivalence of the modified device to a predicate device based on design verification and validation, not on evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study, in the context of an algorithm's performance without human-in-the-loop, was not conducted as described in the provided text. The device is a physical surgical implant and delivery system, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for the tests mentioned appears to be based on engineering specifications and established performance requirements for the device components (e.g., bending strength) and the intended functional outcome of the device in a simulated or actual use environment. This is not "expert consensus, pathology, or outcomes data" in the typical sense of evaluating diagnostic algorithms.
8. Sample Size for the Training Set
The document does not mention a "training set" or its sample size. This is because the device is a physical medical device, not an AI system that requires a training set for model development.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of medical device, the establishment of its "ground truth" is not applicable.
§ 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.