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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.

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

The proposed Ventrio Hernia Patch is a self-expanding, sterile prosthesis, containing two primary layers of 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 AbsorbaFlex Memory Technology, an absorbable polydioxanone (PDO) monofilament. The AbsorbaFlex Memory Technology's PDO monofilament ring provides memory and stability to the device, facilitating ease of initial insertion, proper placement, and fixation of the device. The mesh component of the device is constructed of knitted polypropylene monofilament approximately 0.006" in diameter. The AbsorbaFlex PDO monofilament ring is 0.038" in diameter. It has two donut-shaped layers of knitted polypropylene monofilament mesh 0.006" in diameter on each side of the ring. These layers of mesh are stitched together around the ring using PTFE monofilament. The extra large oval sized patches contain inner and outer PDO monofilament rings. A single layer of expanded ePTFE is attached to the bottom primary layer of polypropylene mesh (posterior mesh). The attachment is accomplished with an interlocking stitch using PTFE monofilament. The peripheral edge of the polypropylene mesh will be heat sealed to the ePTFE layer.

The provided text describes a 510(k) premarket notification for a medical device called the "Ventrio Hernia Patch." This summary focuses on the device's characteristics and its substantial equivalence to predicate devices, rather than presenting a traditional clinical study with acceptance criteria and performance metrics in the format requested.

Therefore, many of the requested fields cannot be directly extracted from the provided text, as this document is a regulatory submission for a hernia patch, not an AI/algorithm-based diagnostic device with performance metrics like sensitivity, specificity, or AUC. The "performance data" mentioned refers to laboratory bench testing and in-vitro/in-vivo resorption studies to demonstrate mechanical strength and resorption characteristics, not diagnostic accuracy.

However, I will populate the table and answer the questions based on the information that is available in the provided text.

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

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

The document does not detail specific sample sizes for "test sets" in a clinical study sense. The performance data relied on "laboratory bench testing" and "in-vitro and in-vivo resorption studies." The provenance of this data (e.g., country of origin, retrospective/prospective) is not specified.

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

Not applicable. This document pertains to a medical device (hernia patch), not an AI/algorithm-based diagnostic tool requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this device would be its physical properties and biological interaction, assessed through laboratory and animal studies, not expert consensus on diagnostic cases.

4. Adjudication method for the test set

Not applicable. See reasoning for point 3.

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

Not applicable. This document describes a physical medical device (hernia patch), not an AI-assisted diagnostic tool.

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

Not applicable. This document describes a physical medical device (hernia patch), not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance would be established through:

• Physical/Mechanical Testing: Measuring properties like tensile strength, tear resistance, and overall structural integrity during laboratory bench testing.
• In-vitro Studies: Assessing material behavior in simulated biological environments.
• In-vivo Resorption Studies: Evaluating the biological degradation and mechanical stability of the absorbable PDO monofilament in living organisms (likely animal models, though not explicitly stated) over time.

8. The sample size for the training set

Not applicable. This document pertains to a medical device (hernia patch), not an AI/machine learning model that requires a training set.

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

Not applicable. See reasoning for point 8.

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