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The ENDOTINE TransBleph™ is intended for use in subperiosteal browplasty. The ENDOTINE TransBleph™ is specifically indicated for use to fixate the subdermis to the frontal bone.

The ENDOTINE TransBleph™ 3.0/3.5 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 document is a 510(k) summary for the ENDOTINE TransBleph™ 3.0/3.5 Device. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance. Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from the provided text.

Here is a breakdown of what can and cannot be answered:

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

• Cannot be provided. The document does not specify quantitative acceptance criteria or a reported device performance study for the ENDOTINE TransBleph™ 3.0/3.5 Device. The submission is based on substantial equivalence to a predicate device and states, "The Modified Device meets all internal functional performance requirements," but no specific criteria or results are listed.

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

• Cannot be provided. There is no mention of a test set or clinical study data in this 510(k) summary.

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 be provided. No test set or ground truth establishment is described.

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

• Cannot be provided. No test set or adjudication process is 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

• Cannot be provided. This device is a surgical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.

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

• Cannot be provided. This is a physical surgical device, not an algorithm.

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

• Cannot be provided. No ground truth establishment related to a performance study is described.

8. The sample size for the training set

• Cannot be provided. This document does not describe the development or training of an algorithm or model.

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

• Cannot be provided. No training set or ground truth establishment for a training set is described.

Summary of what the document does provide:

• Device: ENDOTINE TransBleph™ 3.0/3.5 Device (bioabsorbable implant, insertion tool, drill bit).
• Intended Use: Subperiosteal browplasty surgery, specifically to fixate the subdermis to the cranial bone.
• Regulatory Pathway: 510(k) Premarket Notification.
• Substantial Equivalence: Claimed against the unmodified ENDOTINE TransBleph™ Device (K040740) and other ENDOTINE devices. The basis is similarity in design, materials, fundamental technology, intended use, and performance evaluations (though details of these evaluations are not provided beyond the statement that "The Modified Device meets all internal functional performance requirements").

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