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Intended for the re-attachment of the bone flap after a craniotomy. The OsteoMed Cranial Flap Fixation System is intended for single patient use only.

This submission describes the OsteoMed Cranial Flap Fixation System intended for the re-attachment of the bone flap after a craniotomy. The OsteoMed Cranial Flap Fixation System is intended for single patient use only. The OsteoMed Cranial Flap Fixation System is a clamping device which has a threaded post attached to an inferior disk and a threading superior disk that threads down the post to secure a sandwich fit of the Cranial Flap and cranium between the inferior and superior plate. The device locks into place once the desired fixation is achieved by the surgeon. The OsteoMed Cranial Flap Fixation devices are available in a range of 10mm to 22mm disk diameters.

The provided text describes a medical device, the "OsteoMed Cranial Flap Fixation System," and its 510(k) summary for FDA clearance. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert involvement, ground truth establishment, or any other details related to a study that proves the device meets specific performance criteria.

The document focuses on:

• Device Description: What the device is and how it works.
• Intended Use: For re-attachment of the bone flap after craniotomy.
• Predicate Devices: Identifying similar devices already on the market (MacroPore CraniLoc, Aesculap Craniofix Titanium Clamp System, Lorenz Rapidflap Cranial Clamp).
• Substantial Equivalence: The claim that the device is substantially equivalent to existing devices and raises no new safety or effectiveness issues due to similar materials and design.
• FDA Clearance: The 510(k) clearance letter from the FDA.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and a detailed study as this information is not present in the provided text. The submission relies on "substantial equivalence" to predicate devices rather than presenting a performance study with detailed acceptance criteria.

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