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The CorNeat EverPatch is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface.

The CorNeat EverPatch is a synthetic, tissue-integrating surgical matrix made of non-degradable polymer fibers. The EverPatch includes 6 bio-stitching holes which are intended to anchor the device by facilitating direct conjunctival adhesion to the sclera thus supporting its bio-integration. The holes at each corner can also be used to suture the device to the sclera.

The FDA 510(k) summary for the CorNeat EverPatch focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and detailed study results in the manner typically seen for novel efficacy claims. Therefore, some information, such as precise quantitative acceptance criteria or detailed effect sizes from MRMC studies, is not explicitly provided in this document because it's not required for a 510(k) submission based on substantial equivalence for this type of device.

However, I can extract the relevant information concerning characterization and performance testing that was performed to support the device's safety and bio-compatibility.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific quantitative acceptance criteria or a performance table as usually understood for diagnostic or interventional devices with quantifiable efficacy metrics. Instead, the performance is demonstrated through various bench testing and biocompatibility assessments, with the implicit "acceptance criterion" being that the results are acceptable for safe and effective use, and comparable to the predicate device where relevant.

Reported Device Performance (from "PERFORMANCE DATA" section):

• Biocompatibility: Evaluated per ISO 10993 Biological Evaluation of Medical Devices Part 1, for externally communicating, blood contacting, permanent devices, and FDA Guidance. All listed tests (Cytotoxicity, Maximization Sensitization, Ocular Irritation, Acute Systemic Toxicity, Pyrogenicity, Implantation 13 weeks, Chemical Characterization, Subacute/Sub-chronic Toxicity, Subacute/Chronic Toxicity, Genotoxicity) were performed and presumably met their respective acceptance limits according to the standards.
• Verification and Validation Tests: Performed in accordance with Design Controls (21 CFR §820.30).
  • Dimensional Analysis: Performed.
  • Cheese-wiring: Performed.
  • Mechanical properties: Performed.
  • Sterilization: Performed.
  • Packaging Validation: Performed.
  • Shelf-life: Performed.
  • Pyrogenicity - Bacterial Endotoxin Test (LAL): Performed.
  • Ocular implantation animal study: Performed.

The document implicitly states that these tests demonstrate the device "demonstrates the requirements and is substantially equivalent to the predicate."

2. Sample size used for the test set and the data provenance

• The document mentions an "Ocular implantation animal study" as part of the performance data. However, the specific sample size (number of animals) for this study is not provided.
• The provenance for the animal study (e.g., type of animal) is not specified.
• For the other bench tests, "sample size" typically refers to the number of units tested, which is not specified in this summary.
• Clinical data was not required to demonstrate substantial equivalence, so there is no human test set or data provenance from human subjects for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. Since clinical data was not required and the performance evaluation focused on bench and animal studies (for biocompatibility and physical characteristics), there was no "ground truth" establishment by human experts in the context of clinical interpretation or diagnosis.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. As no human expert evaluation or clinical test set for diagnostic accuracy was part of this submission, there was no need for an adjudication method.

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 device is a passive implantable medical device (prosthesis, eyelid spacer/graft, polymer) not an AI-driven diagnostic or interpretative tool. Therefore, an MRMC study or AI assistance evaluation is irrelevant to this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. As mentioned above, this device is not an algorithm or AI system.

7. The type of ground truth used

• For biocompatibility, the "ground truth" is established by relevant ISO standards (ISO 10993) and FDA guidance, which define acceptable biological responses and material properties.
• For mechanical properties and physical dimensions, the "ground truth" is defined by engineering specifications and design requirements for the device, and assessed through standard engineering testing methodologies.
• For the ocular implantation animal study, the ground truth would be based on histopathological examination and clinical observations derived from the animal models, interpreted by veterinary pathologists or researchers.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."

9. How the ground truth for the training set was established

• Not applicable. As there is no training set for this device.

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