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The ENDOTINE Forehead™ Device is intended for use in subperiosteal browplasty surgery. The ENDOTINE Forehead™ Device is specifically indicated for use to fixate the sub-dermis to the cranial bone in browplasty.

The ENDOTINE Forehead™ Device consists of a bioabsorbable implant and an accessory Instrument Kit. The device implant is a soft tissue fixation platform that is anchored in the cranial bone. The instrument tool kit contains a stainless steel insertion tool, a drill bit and sterilization tray base and lid.

This document is a 510(k) Premarket Notification for the ENDOTINE Forehead™ Device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about specific acceptance criteria, a study demonstrating the device meets those criteria, or any performance metrics.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to an existing device, rather than presenting a detailed performance study with acceptance criteria.

Here's why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: The document does not define any specific acceptance criteria (e.g., in terms of tensile strength, fixation stability, or clinical outcome metrics) or report any performance data against such criteria for the ENDOTINE Forehead™ Device itself. It only states that the modified drill bit "meets all internal functional performance requirements previously established for the predicate device."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or study data is presented.
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, as no study involving expert interpretation or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 surgical implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document asserts substantial equivalence based on design, materials, function, intended use, and performance evaluations (implicitly, internal functional requirements for the drill bit and the overall device's equivalence to the predicate). It does not present a clinical study or specific performance data against defined acceptance criteria.

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