(30 days)
GORE-TEX® DualMesh® Biomaterial is indicated for use in the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.
Biocompatible, expanded polytetrafluoroethylene (ePTFE) with one open microstructure surface and one closed microstructure surface. The open microstructure surface is texturized with a "corduroy" pattern to aid in surface identification and proper surface orientation.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Substantially equivalent to the predicate device. | "Bench test data reveal the applicant device has mechanical strength and material characterization values which are substantially equivalent to the predicate device." |
| Material Characterization | Substantially equivalent to the predicate device. | "Bench test data reveal the applicant device has mechanical strength and material characterization values which are substantially equivalent to the predicate device." |
| Safety | Functions safely as a surgical mesh. | "The histological response shown by in-vivo animal testing demonstrates that the applicant device functions both safely and effectively as a surgical mesh." |
| "The modification described in this Premarket Notification does not raise questions of safety or effectiveness that have not been previously addressed." | ||
| Effectiveness | Functions effectively as a surgical mesh. | |
| Equivalent performance to the predicate device. | "The histological response shown by in-vivo animal testing demonstrates that the applicant device functions both safely and effectively as a surgical mesh." | |
| "In-vivo animal testing demonstrates the applicant device performs equivalent to the predicate device." | ||
| Biocompatibility | Maintained from the predicate device. | "Similarly, the materials, design, biocompatibility, packaging and sterilization process for the applicant device have not changed from those for the predicate device." |
| "The applicant device is substantially equivalent to the predicate device with regard to intended use, possible adverse reactions, materials, design, biocompatibility..." | ||
| Materials | Maintained from the predicate device. | "Similarly, the materials, design, biocompatibility, packaging and sterilization process for the applicant device have not changed from those for the predicate device." |
| "The applicant device is substantially equivalent to the predicate device with regard to intended use, possible adverse reactions, materials, design, biocompatibility..." | ||
| Design | Maintained from the predicate device (other than the surface texturing pattern). | "Similarly, the materials, design, biocompatibility, packaging and sterilization process for the applicant device has not changed from those for the predicate device." |
| "The applicant device is substantially equivalent to the predicate device with regard to intended use, possible adverse reactions, materials, design, biocompatibility..." | ||
| Packaging | Maintained from the predicate device. | "Similarly, the materials, design, biocompatibility, packaging and sterilization process for the applicant device have not changed from those for the predicate device." |
| "The applicant device is substantially equivalent to the predicate device with regard to intended use, possible adverse reactions, materials, design, biocompatibility..." | ||
| Sterilization Process | Maintained from the predicate device. | "Similarly, the materials, design, biocompatibility, packaging and sterilization process for the applicant device have not changed from those for the predicate device." |
| "The applicant device is substantially equivalent to the predicate device with regard to intended use, possible adverse reactions, materials, design, biocompatibility..." | ||
| Intended Use | Unchanged from the predicate device. | "The modified texturing pattern does not change the device's intended use or indications." |
| "The applicant device is substantially equivalent to the predicate device with regard to intended use, possible adverse reactions, materials, design, biocompatibility..." | ||
| Possible Adverse Reactions | Not different from the predicate device. | "The applicant device is substantially equivalent to the predicate device with regard to intended use, possible adverse reactions, materials, design, biocompatibility..." |
| Overall Equivalence | Substantially equivalent to the predicate device regarding intended use, possible adverse reactions, materials, design, biocompatibility, packaging, sterilization process, mechanical strength, and material characterization values. | |
| Performs equivalent to the predicate device. | "The applicant device is substantially equivalent to the predicate device with regard to intended use, possible adverse reactions, materials, design, biocompatibility, packaging, sterilization process, mechanical strength and material characterization values." | |
| "In-vivo animal testing demonstrates the applicant device performs equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated. The document mentions "in-vivo animal testing" but does not specify the number of animals or trials.
- Data Provenance: "in-vivo animal testing" suggests a prospective animal study. The country of origin 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)
- Not applicable. The study is an animal (in-vivo) and bench testing study, not a human reader study requiring expert ground truth for interpretation. The ground truth would be based on histological analysis and mechanical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable in the context of an animal and bench testing study as described.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical mesh, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a medical device (surgical mesh), not an algorithm or AI. The performance is assessed through bench tests and animal studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Bench Testing: Mechanical measurement data and material characterization data.
- Animal Testing: Histological response.
8. The sample size for the training set
- Not applicable. This device is not an AI or machine learning model that requires a training set. The "training" in this context refers to the manufacturing process for the device itself.
9. How the ground truth for the training set was established
- Not applicable. As this isn't an AI model, there isn't a "training set ground truth" in the machine learning sense. The device's design, materials, and manufacturing processes are established based on engineering principles and existing predicate device validation, aiming to meet specific performance standards.
§ 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.