Search Results

The Bard® Ventralex™ Hernia Patch is intended for use in all forms of hernia repair requiring reinforcement with a nonabsorbable support material. The small Bard® Ventralex™ Hernia Patch (4.3 cm / 1.7") is also intended to repair soft tissue deficiencies, including deficiencies caused by trocars.

The proposed Ventralex Hernia Patch is a self-expanding, sterile prosthesis, containing two primary layers of polypropylene mesh stitched with polytetrafluoroethylene (PTFE) monofilament to an expanded polytetrafluoroethylene (ePTFE) sheet. The mesh component is non-absorbable; however, the device contains a fully absorbable recoil ring using SorbaFlex™ Memory Technology, an absorbable polydioxanone (PDO) monofilament.

The mesh is constructed from knitted polypropylene monofilament and forms a strong, porous, support material. The top layer of mesh has a mesh strap and forms a positioning pocket with the second mesh layer. The propylene mesh side promotes tissue in-growth and repairs the defect. The strap and pocket facilitate placement, positioning and fixation of the device. For a reference point, the small Ventralex Hernia Patch is constructed with a depth marker on the positioning strap. The depth marker is polypropylene monofilament dyed with a blue colorant to indicate the position of the device relative to the end of the laparoscopic trocar sleeve. After fixation to the abdominal wall, excess positioning strap material above the fixation line and at the level of the fascia is cut off and discarded.

A layer of ePTFE is stitched with PTFE monofilament thread and edge heat sealed to the polypropylene mesh. The ePTFE layer minimizes tissue attachment to the device. The SorbaFlex Memory Technology is comprised of an absorbable PDO monofilament welded to form a ring. The PDO monofilament recoil ring provides memory and stability to the device, facilitating ease of initial insertion, proper placement, and fixation of the device. The PDO monofilament fully degrades by means of hydrolysis in vivo in 6 - 8 months. The PDO monofilament ring is placed within a mesh tube constructed from a knitted polypropylene monofilament. The purpose of the mesh tube is to contain the PDO monofilament recoil ring during the degradation process.

This document is a 510(k) Premarket Notification for a medical device, specifically a surgical mesh for hernia repair. It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study proving the device meets specific acceptance criteria in the sense of clinical performance metrics.

Therefore, many of the requested categories (acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to this type of regulatory submission, as it focuses on material and design equivalence, not clinical efficacy or diagnostic accuracy.

Here's an breakdown based on the provided text, addressing the applicable points:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of specific acceptance criteria in the way one might for a diagnostic AI or imaging device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" for this 510(k) submission are implicitly met by demonstrating substantial equivalence to predicate devices through various tests.

The reported device performance is described qualitatively rather than with quantitative metrics against predefined numerical thresholds.

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated with numerical values. The text refers to "bench testing results," "in vivo simulated use experiments," and "whole system simulated use testing in an animal model." These are typically qualitative or small-scale engineering/animal studies rather than large clinical test sets with defined sample sizes for statistical inference.
• Data Provenance: The document does not specify country of origin for any data. The studies are described as "bench testing" and "in vivo simulated use experiments" (animal model), implying laboratory-based or preclinical studies. They are prospective in the sense that they were performed specifically for this 510(k) submission or referenced from previous predicate device submissions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device 510(k) for a physical implant, not a diagnostic or AI algorithm requiring expert ground truth for interpretation. The "ground truth" here is the physical and biological performance of the device itself (e.g., does it recoil, is it biocompatible, does the material degrade as expected).

4. Adjudication method for the test set

Not applicable. This type of submission does not involve human readers interpreting data that would require an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

Not applicable. This is a medical device 510(k) for a physical implant, not a diagnostic or AI algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device 510(k) for a physical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" implicitly used for this device involves:

• Bench Testing Standards: Acceptance against predefined engineering specifications for material properties, mechanical performance (e.g., recoil to a flat position), and physical integrity.
• Biocompatibility Standards: Compliance with ISO 10993 standards for biological evaluation of medical devices.
• In Vivo Observations (Animal Model): Direct observation of device behavior in a biological system (e.g., "whole system simulated use testing in an animal model") to ensure it meets user needs.
• Resorption Studies: Chemical and biological analyses to confirm the degradation profile of the absorbable component.

8. The sample size for the training set

Not applicable. This is a medical device 510(k) for a physical implant, not an AI algorithm that requires a training set. The device manufacturing processes would have internal validation data, but this is not typically disclosed as a "training set" in a 510(k) summary.

9. How the ground truth for the training set was established

Not applicable for the same reasons as #8.

Ask a specific question about this device

The Ventrio Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

The Ventrio Hernia Patch is a sterile, single use device indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. This device contains two primary layers of monofilament polypropylene mesh stitched with PTFE monofilament to an ePTFE sheet to form a positioning pocket. The device also contains an absorbable recoil ring using AbsorbaFlex Memory Technology, which provides memory and stability to the device and facilitates ease of initial insertion, proper placement, and fixation of the device. The AbsorbaFlex Memory Technology is comprised of an absorbable polydioxanone (PDO) monofilament, which fully absorbs in vivo between 6-8 months. The polydioxanone monofilament is dyed violet using D & C Violet No. 2.

Here's an analysis of the provided text regarding the Ventrio Hernia Patch, focusing on acceptance criteria and supporting studies:

This submission is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to an already legally marketed predicate device (Ventrio Hernia Patch K081777), rather than proving the de novo effectiveness of a novel device. Therefore, the "acceptance criteria" discussed are primarily about ensuring the proposed device's performance is comparable to the predicate, and not necessarily about meeting specific clinical performance thresholds for a disease outcome in the same way an AI/software device would.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Bench Testing: The document does not specify the exact sample sizes for each type of bench test. It generally states that "Bench testing... was performed."
• Animal Study: The document refers to "A 4 week post-implantation study in a porcine model." It does not specify the number of animals used in this model.
• Data Provenance: Not explicitly stated, but based on the nature of bench and animal studies conducted by a medical device manufacturer, this would be prospective data generated specifically for this submission. The country of origin for the studies is not specified, but the manufacturer is based in the US.

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 mechanical device testing and animal studies, "ground truth" is typically established through standardized measurements and observations by qualified laboratory personnel and veterinary pathologists, not clinical experts in the same way as an AI diagnostic device.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used for clinical endpoints or image interpretation where expert consensus is needed. For bench and animal studies, results are based on objective measurements and pathological assessments, not subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices that assist human readers in making clinical decisions. The Ventrio Hernia Patch is a surgical mesh; its evaluation focuses on its physical and biological performance, not its interpretive aid to human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone performance study was not done. This concept is applicable to AI algorithms. The Ventrio Hernia Patch is a physical medical device.

7. The Type of Ground Truth Used

• Bench Testing: Ground truth was based on product specifications (measurement standards, strength requirements, deployment functionality) and established engineering principles.
• Animal Study: Ground truth was established through histopathological analysis and macroscopic observation by qualified personnel (likely veterinary pathologists) to assess tissue attachment, contracture, in-growth, inflammation, and fibrotic response. This is essentially pathology/biological outcome data in an animal model.

8. The Sample Size for the Training Set

This concept is not applicable to this device and submission. "Training set" refers to data used to train machine learning models. The Ventrio Hernia Patch is a physical medical device, not an AI/software device. There is no algorithm to train.

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

As established in point 8, the concept of a "training set" is not applicable.

Ask a specific question about this device