(88 days)
The GYNECARE TVT SECUR* device is intended for use in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The GYNECARE TVT SECUR* device is a sterile, single patient use device, consisting of one piece of undyed or blue (Phtalocyanine blue, Color index Number 74160) PROLENE* polypropylene mesh (tape) approximately 1.1cm x 8.0cm (approximately ½ x 4 inches). The ends of the device will be sandwiched between pieces of fleece made of polyglactin 910/polydioxanone coated with polydioxanone film. The coated ends are added to facilitate passage (stiffens the ends) and placement (tactile feel for the surgeon) of the mesh implant. Two curved, stainless steel, single use introducers are used to deliver the implant. The introducers are supplied fixed to the implant via a wire through the coated ends and inserters. TVT SECUR is designed to accommodate two surgical techniques: the “Hammock approach” and the “U approach”. The GYNECARE TVT Universal System is a less invasive 'exit less' device which will enable the physician to perform a suburethal sling procedure placing the mesh under the mid urethra without either the delivery device or the implant exiting the skin.
Here's an analysis of the provided text regarding the GYNECARE TVT SECUR System, focusing on acceptance criteria and supporting studies.
Note: The provided text is a 510(k) summary for a medical device (GYNECARE TVT SECUR* System). This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial results with specific acceptance criteria and performance metrics for a novel technology. Therefore, much of the requested information (like specific sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or detailed standalone performance) is not present in this document. The "Performance Data" section in such summaries typically refers to bench testing and verification, not clinical studies in the way one might expect for an AI/software device.
Acceptance Criteria and Device Performance for GYNECARE TVT SECUR System
Based on the provided 510(k) summary, the device is a medical implant intended for the treatment of stress urinary incontinence, not an AI or imaging device with performance metrics like sensitivity/specificity. The "acceptance criteria" here are focused on demonstrating that the modified device is substantially equivalent to existing, legally marketed predicate devices, and that it meets established engineering performance requirements.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from 510(k) context) | Reported Device Performance (as stated or inferred) |
|---|---|---|
| Substantial Equivalence | - Same intended use as predicate device. |
- Similar technological characteristics (form, fit, function, method of operation). | - Intended Use: "A pubourethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency." (Matches predicate's likely intended use).
- Technological Characteristics: "The modified device has the same technological characteristics as the predicate device. The form, fit, function and method of operation are similar." |
| Performance Requirements (Bench/Verification Testing) | - Device meets established engineering and material specifications relevant to its function as a sub-urethral sling (e.g., material strength, dimensions, sterility, appropriate introducer function). | - "Results of verification testing indicates that the product meets the established performance requirements." (Specific numerical results are not provided in this summary). |
| Safety | - Material biocompatibility. - Sterility assurance.
- Mechanical integrity under expected physiological loads. | - Not explicitly detailed in summary, but assumed to be demonstrated through material safety data and verification testing showing no new safety concerns compared to predicate. |
| Effectiveness (Implied) | - Performs its intended function (support of the urethra to treat SUI). | - Implied by substantial equivalence to predicate devices which are already accepted as effective for SUI treatment. No new clinical effectiveness data presented beyond comparison to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of a typical clinical "test set" for performance evaluation described for an AI device. The 510(k) refers to "verification testing," which is usually bench (laboratory) testing of materials and device components. There is no mention of a human test set in the clinical evaluation sense.
- Data Provenance: Not applicable. The "verification testing" would be conducted internally by the manufacturer or a contract lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. This summary does not describe a clinical study requiring expert consensus for ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication method: Not applicable. This summary does not describe a clinical study requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done for this device, as it is a surgical implant and not an imaging or diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance Study: Not applicable. This is not an algorithm-only device. The "performance data" refers to bench testing of the physical device.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the "verification testing," the ground truth would be based on engineering specifications, material properties, and established test methodologies (e.g., tensile strength measurements, dimensional accuracy, sterilization efficacy). For the substantial equivalence argument, the "ground truth" is the performance and safety profile of the predicate device.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model that requires a training set in that sense.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: 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.