(91 days)
Dextile™ Anatomical Mesh is intended to be used for the reinforcement of soft tissues where weakness exists during repair of inguinal hernia by laparoscopic approach.
Dextile™ Anatomical Mesh is designed to be placed in a pre-peritoneal site by laparoscopic approach. The device has an anatomical shape with sealed edges allowing coverage of inguinal hernia defects and facilitating laparoscopic mesh deployment and handling. The mesh is made of a non-absorbable macroporous monofilament polypropylene textile. A green marking is placed on the medial side of the mesh to help positioning and orienting the mesh: "ML" letters designate Medial Line. The green marking is made of monofilament polyester yarn. The "D&C Green No. 6" dye is used for the marking.
This document describes the Dextile Anatomical Mesh, a surgical mesh intended for reinforcing soft tissues during inguinal hernia repair. The device is compared to a predicate device, the 3DMAX Light Mesh (K091659), to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that in vitro (bench) tests were performed in accordance with the FDA Guidance "Guidance for the Preparation of a Premarket Notification Application of a Surgical Mesh" issued March 2, 1999, to evaluate the performance characteristics of the subject device in comparison with the predicate. While specific numerical acceptance criteria or performance values are not provided in the document, the listed characteristics below were "assessed" and the overall conclusion is that the subject device is "substantially equivalent" to the predicate. This implies that the performance fell within acceptable limits or matched the predicate device for these parameters.
| Acceptance Criteria / Performance Characteristic Assessed | Reported Device Performance (Relative to Predicate) |
|---|---|
| Pore size | Assessed; substantial equivalence determined. |
| Surface density | Assessed; substantial equivalence determined. |
| Thickness | Assessed; substantial equivalence determined. |
| Bursting strength | Assessed; substantial equivalence determined. |
| Bursting deflection | Assessed; substantial equivalence determined. |
| Tensile breaking strength | Assessed; substantial equivalence determined. |
| Elongation at break | Assessed; substantial equivalence determined. |
| Tear strength | Assessed; substantial equivalence determined. |
| Suture pull-out strength | Assessed; substantial equivalence determined. |
| Mesh integrity after trocar passage | Demonstrated; mesh integrity preserved. |
| Tissue integration (in animal model) | No difference observed compared to predicate. |
| Shelf life stability | Demonstrated. |
| Biocompatibility | Compliant with ISO Standard 10993-1. |
| Usability | Acceptable for intended users, uses, and environments. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for the various tests.
- In vitro (bench) tests: Implied to be performed by the manufacturer, Sofradim Production, which is based in France. No specific sample sizes mentioned for the mesh characteristics.
- Trocar passage testing: No specific sample size mentioned.
- In vivo pre-clinical tests: Conducted on a "representative animal model." The specific animal model and number of animals are not provided.
- Stability study: No specific sample size mentioned.
- Biocompatibility evaluation: No specific sample size mentioned, as this refers to compliance with a standard.
- Usability tests: No specific sample size or details of participants are given.
The provenance for tests performed by Sofradim Production would be France. The provenance of the animal model for in vivo testing is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is a surgical mesh, not an AI or diagnostic device that requires expert interpretation for ground truth establishment in the typical sense (e.g., radiologists interpreting images). The "ground truth" for this device's acceptance criteria primarily relies on objective physical measurements, in vitro testing, animal study observations, and compliance with established biocompatibility and usability standards. Therefore, the concept of "experts establishing ground truth for a test set" as described in the prompt does not directly apply in the context of this traditional medical device submission. The FDA evaluates the submitted data and methodology to determine substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is not an AI or diagnostic device submission involving human interpretation of data, there is no adjudication method used for a test set in this context. The evaluation is based on scientific testing and comparison to a predicate device.
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 is a surgical mesh, not an AI-assisted diagnostic or interpretation device. Therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (surgical mesh), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the Dextile Anatomical Mesh, the "ground truth" for establishing substantial equivalence and meeting acceptance criteria relies on:
- Objective quantitative measurements: For in vitro (bench) tests such as pore size, density, strength, elongation, etc. The "truth" is derived from calibrated measurement instruments.
- In vivo observations in animal models: For tissue integration, observed by qualified veterinary professionals or researchers.
- Compliance with recognized standards: Such as ISO Standard 10993-1 for biocompatibility.
- Functional demonstrations: Like the preservation of mesh integrity during trocar passage.
- Comparative analysis: Direct comparison of the subject device's characteristics and performance to those of the legally marketed predicate device (3DMAX Light Mesh K091659).
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.