(98 days)
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
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Material Composition Equivalence | The Ventrio Hernia Patch contains two primary layers of knitted polypropylene monofilament mesh and an expanded polytetrafluoroethylene (ePTFE) sheet, similar to predicate devices. It uses a fully absorbable recoil ring made of polydioxanone (PDO) monofilament. |
| Mechanical Strength | Laboratory bench testing was performed to compare the Ventrio Hernia Patch to the Bard Composix Kugel Hernia Patch. |
| Resorption Characteristics | In-vitro and in-vivo resorption studies were performed on the PDO monofilament. These studies characterized the mechanical strength and resorption. |
| Intended Use Equivalence | The intended use for the Ventrio Hernia Patch is stated to be the same as the predicate device (Bard Composix Kugel Hernia Patch), "with the exception of the indication for repair of chest wall defects." |
| Safety and Effectiveness | Based on laboratory testing and in-vitro and in-vivo resorption data, the results show that the proposed device is as safe and effective for its intended use as the currently marketed predicate device. |
| Substantial Equivalence | Based on performance data, the proposed device is determined to be substantially equivalent to the predicate device (Bard Composix Kugel Hernia Patch (K061314)). |
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.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.