(51 days)
The devices are indicated for use in the reconstruction of hernias and soft/tissue deficiencies and for the temporary bridging of fascial defects.
Inert, biocompatible, expanded polytetrafluoroethylene (ePTFE) loaded with the antimicrobial preservative agents silver carbonate and chlorhexidine diacetate.
The provided text is a 510(k) Premarket Notification summary for medical devices, specifically GORE-TEX® soft tissue patches and biomaterials. This document focuses on a modification to the indications for use for these devices, which are already marketed and cleared.
Crucially, this document does not describe a study involving a device that produces a "performance" or "diagnostic" outcome that would have acceptance criteria in the way described in your request.
Here's why and how I'll address your request given the nature of the document:
- No "Device Performance" in the AI/Diagnostic Sense: The devices described (surgical meshes) are inert implants. Their "performance" relates to their biocompatibility, mechanical strength, and the efficacy of embedded antimicrobial agents, not to a diagnostic accuracy or output that can be measured with metrics like sensitivity, specificity, or AUC.
- Focus on Substantial Equivalence: The entire submission hinges on demonstrating "substantial equivalence" to predicate devices, meaning the modified devices are as safe and effective as existing legally marketed devices.
- No AI/Algorithm Involved: There is no mention of AI, algorithms, a test set, ground truth, or human-in-the-loop performance.
Therefore, most of the requested fields are not applicable to this type of regulatory submission. However, I can interpret the request in the context of the document's purpose (demonstrating safety and effectiveness for a change in indications) and provide information where relevant.
Modified Response based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Criterion (as implied by FDA 510(k) process) | Reported Device Performance/Conclusion (as per document) |
|---|---|---|
| Material Composition | Same as predicate devices | Applicant devices are "Inert, biocompatible, expanded polytetrafluoroethylene (ePTFE) loaded with the antimicrobial preservative agents silver carbonate and chlorhexidine diacetate." This is unchanged from predicate devices with PLUS designation. |
| Design Characteristics | Same as predicate devices | "The materials, design and performance characteristics for the applicant devices have not changed from those of the predicate devices." |
| Indications for Use (Changed Element) | Updated indications do not raise new questions of safety or effectiveness compared to predicate devices. | "The devices are indicated for use in the reconstruction of hernias and soft/tissue deficiencies and for the temporary bridging of fascial defects." The modification "does not raise questions of safety or effectiveness that have not been previously addressed" regarding the predicate devices without antimicrobial agents (the new indications are for devices with antimicrobial agents). |
| Antimicrobial Activity | Equivalent to predicate devices with antimicrobial agents (PLUS designation) | Devices are cited as "substantially equivalent predicate devices concerning possible adverse reactions, materials, design, biocompatibility, mechanical strength, manufacturing, packaging, sterilization, antimicrobial activity and preservative efficacy" to other GORE-TEX PLUS devices. The "preservative effectiveness" and "antimicrobial activity" are considered substantially equivalent. |
| Biocompatibility | Equivalent to predicate devices | Cited as substantially equivalent in terms of "biocompatibility" to predicate devices. The devices are described simply as "Inert, biocompatible." |
| Mechanical Strength | Equivalent to predicate devices | Cited as substantially equivalent in terms of "mechanical strength" to predicate devices. |
| Manufacturing, Packaging, Sterilization | Equivalent to predicate devices | Cited as substantially equivalent in terms of "manufacturing, packaging, sterilization" to predicate devices. |
| Overall Safety and Effectiveness Conclusion | Substantially equivalent to predicate devices for intended use, and changed indications do not alter this. | "The applicant devices are the same, and consequently, substantially equivalent to the predicate devices with regard to possible adverse reactions, materials, design, biocompatibility, preservative effectiveness, antimicrobial activity, mechanical strength, packaging, manufacturing process and sterilization process." "The modification of the indications for use for the applicant devices does not raise questions of safety or effectiveness that have not been previously addressed." |
2. Sample size used for the test set and the data provenance
- Not Applicable. This document is a regulatory submission for a modification of indications for existing devices based on substantial equivalence, not a performance study with a "test set" in the context of diagnostic or AI performance. The equivalence is established by comparing the characteristics of the applicant devices to already cleared predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. There is no "test set" or "ground truth" to be established by experts in the context of a diagnostic or AI evaluation. The FDA regulators are the "experts" who review the substantial equivalence claims.
4. Adjudication method for the test set
- Not Applicable. No test set involved.
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 not an AI or diagnostic device that involves human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. No algorithm or AI is involved.
7. The type of ground truth used
- Not Applicable. There is no "ground truth" in the diagnostic sense. The "ground truth" for this submission is that the predicate devices are already considered safe and effective by the FDA for their initial indications, and the applicant is demonstrating that their modified devices (unchanged physically, just in labeling) are still substantially equivalent to those predicates for the new indications.
8. The sample size for the training set
- Not Applicable. No AI model to train.
9. How the ground truth for the training set was established
- Not Applicable. No AI model to train or ground truth for a training set.
§ 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.