(26 days)
The PARIETEX™ Optimized Composite Mesh (PCO) is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
The PARIETEX™ Optimized Composite Mesh (PCO) is available in rectangular and round shape. This device is made out of a three-dimensional multifilament polyester knit for wall reinforcement, covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and glycerol, and juts out 5 mm over the edge of the reinforcement.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the PARIETEX™ Optimized Composite Mesh, structured to answer your specific questions.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K110812) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and performance against those criteria as would be found in a full study report.
However, based on the text, we can infer the key performance areas and the general findings:
| Acceptance Criteria (Inferred from document) | Reported Device Performance (PARIETEX™ Optimized Composite Mesh) |
|---|---|
| Mechanical Resistance / Improved Mechanical Properties (implied from "higher mechanical resistance of the mesh" and "improved mechanical properties") | "demonstrate improved mechanical properties" compared to predicate devices. The knitting textile was modified to achieve this. |
| Handling Resistance of Film (implied from "film more resistant to handling") | The collagen film formulation was changed to achieve a film that is "more resistant to handling." Specific quantitative improvement is not detailed, but the change was made to address this. |
| Equivalent In-Vivo Minimizing Tissue Attachment Property (implied target for new collagen film formulation) | "equivalent in-vivo minimizing tissue attachment property" compared to predicate devices. This property is attributed to the absorbable hydrophilic film minimizing tissue attachment in direct contact with viscera. |
| Overall Performance Characteristics Equivalence (primary goal for 510(k) submission) | "equivalent in performance characteristics to the predicates PARIETEX™ Composite Mesh." This is the overarching conclusion drawn from all performance testing. |
| Safety and Effectiveness (fundamental requirement for device clearance) | Implied to be equivalent in safety and effectiveness for the stated indications for use (reinforcement of tissues during surgical repair, incisional hernias, abdominal wall repair, parietal reinforcement) based on the substantial equivalence determination by FDA. No adverse events are reported in this summary. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes used for the "bench testing" and "pre-clinical study." It only states that these tests were performed:
- Sample Size: Not specified.
- Data Provenance: Not specified regarding country of origin or whether it was retrospective or prospective. "Pre-clinical study" typically implies animal studies or in-vitro tests, which are prospective. "Bench testing" is in-vitro.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and is not provided in a 510(k) summary for a surgical mesh. The testing performed involves objective measurements (mechanical properties, tissue attachment) rather than subjective assessments requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. The listed studies (bench testing, pre-clinical study) are objective tests, not subjective assessments requiring expert 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
An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving image interpretation by human readers, and the PARIETEX™ Optimized Composite Mesh is a surgical implant. There is no AI component mentioned or human-in-the-loop performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
A standalone algorithm performance study was not done. This is not an AI/software device. The performance studies are for the physical properties and biological interaction of the surgical mesh.
7. The Type of Ground Truth Used
For the studies mentioned:
- Bench Testing: The ground truth would be based on objective physical measurements (e.g., tensile strength, burst strength, tear resistance) performed according to established test methods and standards (likely related to "Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh").
- Pre-clinical Study: The ground truth for "minimizing tissue attachment property" would likely be derived from histological examination or macroscopic assessment of tissue ingrowth/adhesion in animal models, comparing the new device to the predicate. The "ground truth" here is the scientific observation and measurement of biological response to the implanted material.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI/machine learning device that requires a training set. The "design modifications" (new collagen film formulation, changes to knitting) were likely the result of R&D and engineering design cycles, potentially using iterative testing, but not in the sense of a machine learning training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI model.
§ 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.