Search Results
Found 1 results
510(k) Data Aggregation
(74 days)
GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM
The TVT device is intended to be used as a pubourethral sling for treatment of stress urinary incontinence (SUI). The TVT device is intended to be used as a pubourethral sling indicated for treatment of stress urinary incontinence (SUI) for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The TVT Introducer, Rigid Catheter Guide and TVT abdominal Guides and Couplers accessories are intended to facilitate placement of the TVT device.
The Tension Free Vaginal Tape (TVT) System is comprised of three components; the device (TVT device) and its accessories (TVT Introducer and TVT Rigid Catheter Guide and TVT Abdominal Guides and Couplers). Each is available separately for use at the surgical site. The TVT device is composed of unpigmented or blue pigmented PROLENE polypropylene mesh (tape). The mesh is covered with a polyethylene sheath with a slit in the middle. Both the mesh and sheath are attached to two (2) stainless steel needles. The TVT Introducer (accessory) is made of stainless steel. It is composed of three (3) parts; handle, threaded shaft and rubber O-ring. The introducer functions to facilitate passage of the TVT device from the vagina to the abdominal skin. The TVT Rigid Catheter Guide is made of stainless steel and used to add rigidity to the Foley Catheter during the surgical procedure. The TVT AA (Accessory) Abdominal Guide is made of stainless steel and the couplers are made from polypropylene.
Here's the analysis of the provided text regarding the acceptance criteria and study for the K012628 device:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the device (GYNECARE Tension Free Vaginal Tape (TVT) System with Accessories) is a medical device, not an AI/software device. Therefore, the "acceptance criteria" and "reported device performance" are not presented in terms of AI metrics (like accuracy, sensitivity, specificity). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.
The acceptance criteria for substantial equivalence are implicitly met by demonstrating that the modified device has the same technological characteristics and functions as clinically intended as the predicate device.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Technological Characteristics: The modified device should be technologically the same as the predicate device. | "Technologically both the modified TVT Blue device and the currently marketed predicate device are the same." |
| The TVT-AA Abdominal Guides and Couplers (an accessory) is an addition to facilitate an abdominal approach, but the core device technology is stated to be the same. | |
| Clinical Functionality: The modified device should function as clinically intended. | "Results of bench testing and preclinical evaluations were used to show that the TVT System functioned as clinically intended and have the same product properties." |
| Product Properties: The modified device should have the same product properties as the predicate device. | "Results of bench testing and preclinical evaluations were used to show that the TVT System functioned as clinically intended and have the same product properties." |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not mention a "test set" in the context of an AI/software evaluation. The studies conducted were "bench testing and preclinical evaluations." The sample sizes for these tests are not specified in the provided document.
The data provenance (country of origin, retrospective/prospective) is also not specified, as these are typically not documented for physical device bench and preclinical testing in the same way they would be for a data-driven AI study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the device is not an AI/software product requiring expert ground truth for image interpretation or diagnosis. The evaluation relies on engineering and biological testing.
4. Adjudication Method for the Test Set
This information is not applicable as there is no "test set" in the context of an AI/software evaluation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to this physical medical device.
6. If a Standalone (Algorithm Only) Performance Study was Done
No, a standalone performance study was not done. This concept is specific to AI algorithms and their direct output without human intervention, which is not relevant for this physical device.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation was based on:
- Bench testing: Involving physical measurements and evaluations of material properties and mechanical performance.
- Preclinical evaluations: Likely animal studies or cadaveric studies to assess functionality, tissue interaction, and safety before human use.
The document states these evaluations showed the device "functioned as clinically intended and have the same product properties" as the predicate.
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI/software product that uses a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this physical medical device.
Ask a specific question about this device
Page 1 of 1