(85 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bench Testing | |
| Linear verification | Met product specifications |
| Visual inspections | Met product specifications |
| Recoil testing | Met product specifications |
| Ball burst strength testing | Met product specifications |
| Suture pullout testing | Met product specifications |
| Laparoscopic deployment testing | Met product specifications |
| PDO containment testing | Met product specifications |
| Mesh/fixation holding strength | Met product specifications |
| PDO weld testing (Predicate device, as no PDO change) | Met product specifications |
| Monofilament testing (Predicate device, as no PDO change) | Met product specifications |
| Seal strength testing (Predicate device, as no packaging change) | Met product specifications |
| Package qualification testing (Predicate device, as no packaging change) | Met product specifications |
| Biocompatibility testing (Predicate device, as no material change) | Met product specifications |
| Animal Studies | |
| Tissue attachment (4-week porcine model) | Comparable to predicate device |
| Mesh contracture (4-week porcine model) | Comparable to predicate device |
| Tissue in-growth (4-week porcine model) | Comparable to predicate device |
| Host inflammatory and fibrotic response (4-week porcine model) | Comparable to predicate device |
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.
§ 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.