Search Results

The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of Stress Urinary Incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and are intended to facilitate in the placement of the GYNECARE TVT Device.

The GYNECARE TVT Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically.

The GYNECARE TVT Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during the placement of the GYNECARE TVT Device.

The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and GYNECARE TVT Abdominal Guides and Couplers are included in each kit.

The GYNECARE TVT Abdominal Guides and Couplers are single use devices used to facilitate placement of the GYNECARE TVT Device when placed in a top-down retropubic fashion (also known as an abdominal approach).

The GYNECARE TVT EXACT Continence System is intended to be used as a pubo-urethral sling for treatment of female Stress Urinary Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The GYNECARE TVT EXACT Continence System Trocar is a single use device intended to aid in the placement of the GYNECARE TVT EXACT Continence System retropubically.

The GYNECARE TVT Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during the placement of the GYNECARE TVT EXACT Continence System.

The GYNECARE TVT Obturator Device 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.

The GYNECARE TVT Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT Obturator Device.

The GYNECARE TVT ABBREVO Continence System is intended for use in women as a suburethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The GYNECARE TVT ABBREVO Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO Device.

GYNECARE TVT™ Tension-free Vaginal Tape System: Consists of PROLENE™ Polypropylene Mesh (tape) with clear plastic Sheaths and stainless steel needles. The mesh is knitted filaments of extruded polypropylene strands. GYNECARE TVT™ Reusable Introducer (available separately) is a reusable stainless steel instrument. GYNECARE TVT™ Rigid Catheter Guide (available separately) is a non-sterile reusable stainless-steel instrument.

GYNECARE TVT™ with Abdominal Guides Tension-free Support for Incontinence System: Includes GYNECARE TVT™ Abdominal Guide, a sterile disposable instrument, and GYNECARE TVT™ Coupler, a sterile disposable polypropylene connector.

GYNECARE TVT EXACT™ Continence System: A sterile, single patient use procedure kit consisting of the GYNECARE TVT EXACT Continence System Trocar Sheath / Implant Assembly (blue PROLENE™ Polypropylene Mesh with clear plastic Sheaths and white Trocar Sheaths) and the GYNECARE TVT EXACT Continence System Trocar (stainless-steel Trocar Shaft and plastic Trocar Handle).

GYNECARE TVT™ Obturator System: A sterile, single patient use procedure kit consisting of the GYNECARE TV Obturator Device (undyed or blue PROLENE™ polypropylene mesh with clear plastic sheath and plastic tube receptacles) and the GYNECARE TVT™ Obturator Helical Passers and Atraumatic Winged Guide (two stainless steel, curved wire helical passers with plastic handles and a stainless steel accessory instrument).

GYNECARE TVT ABBREVO™ Continence System: A sterile, single-patient use procedure kit consisting of the GYNECARE TVT ABBREVO Implant Assembly (blue PROLENE™ Polypropylene Mesh with clear plastic Sheaths and Helical Passer Sheaths, and Positioning Lines) and the GYNECARE TVT ABBREVO Placement Loop (PROLENE Polypropylene Monofilament loop with an attached polypropylene button). Also includes GYNECARE TVT ABBREVO™ Helical Passers and Atraumatic Winged Guide (two stainless steel, curved wire helical passers with plastic handles and a stainless steel accessory instrument).

The provided document is a 510(k) summary for the GYNECARE TVT™ System and related devices. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and efficacy through new clinical studies against specific acceptance criteria.

Therefore, the document does not contain information about:

• Clearly defined acceptance criteria for device performance.
• A standalone study proving the device meets specific acceptance criteria.
• Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for test and training sets.

Instead, the document states:

• Substantial Equivalence: The primary assertion is that "the subject devices are substantially equivalent to their respective predicate devices."
• Technological Characteristics: "The subject devices and their respective predicate devices are identical and therefore have the same technological characteristics."
• Differences from Predicates: The only stated differences are in "labeling (Instructions for Use)" which have been "revised to meet the new European Union (EU) Medical Device Regulation (MDR) requirements" and include additional information such as warnings, adverse events, safety information, and information for patients. Minor clarifications to "Indications and Contraindications statements" were also made.
• Performance Data: "No performance data are needed to evaluate these labeling changes." This explicitly states that no new performance studies were conducted or required for this particular submission.

In summary, there is no study described in this document that proves acceptance criteria because the submission's purpose is to demonstrate substantial equivalence based on identical technological characteristics and updated labeling, not new performance data.

Ask a specific question about this device

The Gynecare TVT ABBREVO™ Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO™ device.

The Gynecare TVT™ Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT™ Obturator device.

The Helical Passers are two stainless steel, curved wire passers with plastic handles that are designed to deliver the GYNECARE TVT ABBREVO™ & GYNECARE TVT™ Obturator Implant. The Helical Passers are provided as left and right units, pre-assembled to the GYNECARE TVT ABBREVO™ & GYNECARE TVT™ Obturator Implant Assembly.

The Winged Guide is a stainless steel accessory instrument that facilitates consistent passage of the GYNECARE TVT ABBREVO™ & GYNECARE TVT™ Obturator Implant Assembly through the dissection tract.

The provided document is a 510(k) summary for surgical instrumentation and describes performance testing for those instruments, not for an AI/ML device. Therefore, it does not contain information about acceptance criteria or studies related to AI/ML device performance.

The document discusses the following types of performance testing for the GYNECARE TVT ABBREVO™ and GYNECARE TVT™ Obturator Helical Passers and Atraumatic Winged Guide:

• Sterilization validation: To demonstrate the devices are sterile to an SAL of 10^-6.
• Package integrity: To ensure the sterility of the packaged devices.
• Dimensional and mechanical performance: To confirm the instruments meet design specifications and can withstand intended use.
• Biocompatibility: Including cytotoxicity, sensitization, and irritation tests to ensure the materials are safe for patient contact.
• Shelf life: To validate the stability and performance of the devices over their intended storage period.

The document concludes that the subject devices are substantially equivalent to their predicate devices and meet the special controls outlined in 21 CFR 884.4910.

Since this document does not pertain to an AI/ML device, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML performance.

Ask a specific question about this device

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.

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.

Ask a specific question about this device