(25 days)
The GYNECARE TVT EXACT™ Continence System is intended to be used as a pubourethral sling for treatment of female Stress Urinary Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The proposed 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, which is identical in material and dimensions to the implant of currently marketed GYRECARE TVT™ Device. 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.
The provided text describes the GYNECARE TVT EXACT™ Continence System, a surgical mesh device. The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of its effectiveness against specific acceptance criteria in the manner of a new drug or novel medical device requiring extensive clinical trials.
Therefore, the information required to populate all fields of your requested table and study description is not explicitly available in the provided document. The data mainly pertains to device design, materials, and functional equivalence to a previously approved device.
Here's an attempt to extract and infer information based on the provided text, highlighting where data is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Equivalence | Implant material and dimensions identical to predicate device (PROLENE™ Polypropylene Mesh, ~1/2 inch wide, 18 inches long, ~0.027 inches thick). | The GYNECARE TVT EXACT™ Continence System Implant is "identical in material and dimensions to the implant of currently marketed GYRECARE TVT™ Device." (Page 21) |
| Principle of Operation | Principle of operation and fundamental scientific technology equivalent to predicate devices (GYNECARE TVT™). | "The principle of operation and fundamental scientific technology of the modified device are equivalent to the predicate devices." Both devices introduce a retropubic synthetic mesh sling for mid-urethral support. (Page 22) |
| Mechanical/Physical Testing | Established performance requirements for: |
- Key dimensions
- Trocar Shaft Yield Force
- Peak Torque of Trocar Shaft
- Penetration Force
- Lock Failure Force of Trocar Sheath | "Results of verification testing (such as measurement of key dimensions, Trocar Shaft Yield Force, Peak Torque of Trocar Shaft, Penetration Force, and Lock Failure Force of Trocar Sheath) indicates that modified device meets the established performance requirements." (Page 22) Specific thresholds or numerical results are not provided. |
| Intended Use | Indication for use as a pubourethral sling for female Stress Urinary Incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency. | The device is intended for this use, and the FDA's "Indications for Use" enclosure confirms this. (Page 19, 4) |
| Substantial Equivalence | The device must be demonstrated substantially equivalent to the predicate device(s) in terms of safety and effectiveness. | "Based on the similarities to the predicate device identified in this submission as well as the outcome of design verification we conclude that the modified device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act." (Page 22) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as this is a 510(k) submission primarily relying on design verification and equivalence to a predicate, rather than a clinical performance study with a distinct "test set" of patients in the context of AI/diagnostic device evaluation. The "test set" here refers to components/systems tested for mechanical properties. The document does not specify the number of devices or components subjected to the verification testing.
- Data Provenance: The verification testing was conducted by Ethicon, Inc. (Johnson & Johnson Company). The country of origin of the data is not specified but would likely be the USA (where Ethicon is based) or facilities globally where their testing is performed. The data is retrospective in the sense that it's a summary of internal design verification testing, not a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not specified. The "ground truth" for this type of device (surgical mesh) is primarily based on engineering specifications and material science, and its performance is assessed through mechanical testing and comparison to an established predicate device. Clinical outcomes, while relevant for predicate approval, are not the focus of this 510(k) submission's comparative data.
- Qualifications of Experts: Not specified. Design verification testing would be overseen by engineers and quality assurance personnel with relevant expertise in medical device manufacturing and testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This document describes design verification and substantial equivalence, not a clinical study with subjective interpretations requiring adjudication. Mechanical test results are typically quantitative and objective.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This is a medical device (surgical mesh and delivery system), not an AI-powered diagnostic or interpretive device. Therefore, MRMC studies and "human readers improving with AI" are not relevant or applicable to this submission.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical surgical mesh and trocar system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth Type:
- Engineering Specifications/Material Standards: For the physical properties (dimensions, forces, torque).
- Predicate Device Performance: The primary "ground truth" for this 510(k) is the established safety and effectiveness of the GYNECARE TVT™ Tension-free Vaginal Tape (K974098) as demonstrated through its prior approval and market history. The new device's performance is measured against the predicate device's characteristics and known performance.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device does not involve machine learning or AI that would require a "training set."
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable, as there is no training set for this type of device and submission. The "ground truth" for the overall substantial equivalence determination rests on the predicate device's established safety and effectiveness.
Summary of Device and Approval Context:
This document is a 510(k) Premarket Notification for a Class II medical device. The primary goal of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This typically involves showing that the device has the same intended use and either has the same technological characteristics as the predicate, or has different technological characteristics but is as safe and effective as the predicate, and does not raise different questions of safety and effectiveness.
For the GYNECARE TVT EXACT™ Continence System, the demonstration of substantial equivalence relies heavily on:
- Identical materials and dimensions for the mesh implant.
- Equivalent principle of operation.
- Verification testing to show the modified components (e.g., trocar, sheath) meet established performance requirements, implying they perform at least as well as or within acceptable limits compared to the predicate's components.
It's crucial to understand that a 510(k) submission generally does not require new large-scale clinical trials or detailed effectiveness studies if substantial equivalence can be shown through other means (e.g., bench testing, material comparisons, reliance on predicate's clinical history). The "acceptance criteria" here are those demonstrating this equivalence.
§ 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.