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The ENDOTINE Forehead™ Triple is intended for use in subperiosteal browplasty surgery. The ENDOTINE Forehead™ Triple Device is specifically indicated for use to fixate the subcutaneous tissues to the cranial bone in browplasty.

The ENDOTINE Forehead™ Triple Device consists of a bioabsorbable implant, an insertion tool, and stainless steel drill bit. The device implant is a soft tissue fixation platform that is anchored in the cranial bone. The insertion tool and the drill bit are sterilized together with the implant device in a plastic tray.

This 510(k) summary (K042078) for the ENDOTINE Forehead™ Triple Device does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the manner typically seen for performance studies in AI/ML medical devices.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices (K014153 and K023922) based on design, materials, fundamental technology, and intended use. The key statement regarding performance is: "The modified device meets all internal functional performance requirements previously established for the predicate device."

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about specific study details like sample sizes, expert qualifications, adjudication methods, or MRMC studies, as these types of studies are not described in this submission.

Here's a breakdown of what can be extracted and what cannot:

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

• Cannot provide. The document states that the device "meets all internal functional performance requirements previously established for the predicate device," but it does not specify what those requirements are or what performance metrics were evaluated.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot provide. No information on a test set or its provenance is included.

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)

• Cannot provide. No information on ground truth establishment or expert involvement in a test set is included.

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

• Cannot provide. No information on an adjudication method is included.

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

• Cannot provide. This is a hardware device (bioabsorbable implant) and not an AI/ML diagnostic or assistive device. Therefore, MRMC studies involving human readers and AI assistance are not applicable and not mentioned.

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

• Cannot provide. This is a hardware device. The concept of "standalone algorithm performance" does not apply.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot provide. No specific ground truth methodology is described. The approval is based on substantial equivalence, implying that the safety and effectiveness of the updated device are inferred from the predicate devices' established performance.

8. The sample size for the training set

• Cannot provide. No information on a training set is included, as this is a hardware device, not a machine learning model.

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

• Cannot provide. As there's no training set, there's no ground truth establishment for it.

Summary from the provided document:
The approval for the ENDOTINE Forehead™ Triple Device (K042078) is based on substantial equivalence to its predicate devices (K014153 and K023922). The submission states that "no different issues of safety or effectiveness have been raised for the modified Forehead device. The modified device meets all internal functional performance requirements previously established for the predicate device." This means the assessment was primarily a comparison of design, materials, and intended use, rather than a new clinical or performance study with defined acceptance criteria and statistical analysis as would be expected for a novel device or an AI/ML product.

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