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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.

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

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

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 subject devices include the following components:

GYNECARE TVT™ Reusable Introducer
GYNECARE TVTTM Reusable Rigid Catheter Guide
GYNECARE TVT EXACT™ Continence System Trocar

The subject devices are intended to be used with the GYNECARE TVT™ Device and GYNECARE TVT EXACT™ Continence System intended to treat stress urinary incontinence.

GYNECARE TVT™ Reusable Introducer
The GYNECARE TVT™ Introducer is provided non-sterile and is reusable. The Introducer is made of stainless steel. It consists of two parts, a handle and an inserted threaded metal shaft. The Introducer is intended to facilitate the passage of the GYNECARE TVT™ Device from the vagina to the abdominal skin. It is connected and fixed to the threaded end of the shaft, prior to inserting the needle with the tape.

GYNECARE TVT™ Reusable Rigid Catheter Guide
The GYNECARE TVT™ Rigid Catheter Guide is a non-sterile reusable instrument intended to facilitate the identification of the urethra and the bladder neck during the surgical procedure. It is inserted into a Folev catheter (recommended size 18 French) positioned in the urethra. To facilitate insertion, it can be lubricated with gel.

GYNECARE TVT EXACT™ Continence System Trocar
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.

This document describes a 510(k) premarket notification for reusable surgical instruments (GYNECARE TVT™ Reusable Introducer, GYNECARE TVT™ Reusable Rigid Catheter Guide) and a single-use instrument (GYNECARE TVT EXACT™ Continence System Trocar), which are accessories for urogynecologic surgical mesh systems. The submission asserts substantial equivalence to predicate devices (K974098 and K132054).

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail threshold manner for performance. Instead, it lists the types of performance tests conducted and concludes that the devices meet the requirements, implying that the results of these tests were considered acceptable.

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not specify the sample sizes used for any of the performance tests (e.g., how many devices were tested for mechanical performance, sterilization, or reprocessing).

The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. These were likely conducted in a controlled laboratory environment by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This type of information is not applicable to the performance characteristics studied for these medical instruments. The "ground truth" for mechanical performance, sterility, or biocompatibility is established through objective laboratory testing and industry standards, not through expert consensus on interpretation, as might be the case for an AI diagnostic device.

4. Adjudication Method for the Test Set:

This is not applicable as the tests relate to objective engineering and biological performance characteristics, not subjective clinical interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. These devices are surgical instruments, not diagnostic tools that would directly assist human readers in interpreting images or data. Therefore, the concept of "effect size of how much human readers improve with AI vs. without AI assistance" is not relevant here.

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 an algorithm is not applicable. These are physical medical devices, not software algorithms.

7. The type of ground truth used:

The "ground truth" for these tests would be established by:

• Sterilization Validation: Demonstrated sterility to a specified Sterility Assurance Level (SAL) through objective microbiological testing.
• Mechanical Performance: Adherence to engineering specifications and relevant industry standards for strength, durability, and dimensional accuracy, measured objectively.
• Biocompatibility: Compliance with ISO 10993 standards, assessed through laboratory tests (e.g., cell culture for cytotoxicity, animal models for sensitization/irritation).
• Reprocessing Validation: Demonstrated effectiveness of cleaning, disinfection/sterilization, and functional integrity after multiple reprocessing cycles, verified through objective testing.
• Package Integrity: Objective tests to ensure sterile barrier integrity.
• Shelf Life: Stability and functional integrity over time, verified through accelerated aging or real-time shelf-life studies.

8. The Sample Size for the Training Set:

This concept is not applicable. These are physical medical instruments and do not involve machine learning algorithms that require training data.

9. How the Ground Truth for the Training Set was Established:

This concept is not applicable for the same reason as above (no machine learning involved).

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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

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.

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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

• 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:

1. Identical materials and dimensions for the mesh implant.
2. Equivalent principle of operation.
3. 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.

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