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The Cranion™ Cranial Fixation System intended for reconstruction of the craniomaxillofacial skeleton and for reattachment of cranial bone flaps after craniotomy procedures. The system is used to align and stabilized bony tissue while normal healing occurs. Each implantable component is intended for single use only and may be combined only with other titanium and titanium alloy implants.

The Cranion™ Cranial Fixation System includes a variety of plate configurations for different anatomical applications. Titanium alloy plates, and titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue. Titanium alloy clamps and clips are included for the reattachment of cranial bone flaps after craniotomy procedures.

This submission (K051293) is for a Cranion™ Cranial Fixation System, a medical device used for cranial and maxillofacial surgery. The FDA has found the device to be substantially equivalent to legally marketed predicate devices. This means that the device meets the safety and effectiveness criteria that generally apply to similar devices already on the market.

Acceptance Criteria and Reported Device Performance

Study Information

Based on the provided text, the submission (K051293) is a 510(k) Premarket Notification. This type of submission generally relies on demonstrating substantial equivalence to predicate devices rather than conducting a new, comprehensive clinical study to prove the device meets novel acceptance criteria.

Therefore, many of the requested study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set) are not applicable in the context of this 510(k) submission, as it does not describe a clinical trial or performance study as typically understood for new device approvals. Instead, the "study" is a comparative analysis demonstrating substantial equivalence to pre-existing, legally marketed devices.

Here's why some points are not present:

• 1. A table of acceptance criteria and the reported device performance: This is addressed above by framing "substantial equivalence" and "intended use" as the primary acceptance criteria for a 510(k) and comparing the device's described attributes to these.
• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No specific test set or data from a clinical study for K051293 is described. The "test set" is, in essence, the comparison of the device's specifications and intended use against those of the predicate devices.
• 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. "Ground truth" in this context refers to the established safety and efficacy of the predicate devices, as determined by prior FDA approvals and market experience.
• 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 cranial fixation system, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a cranial fixation system, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for a 510(k) is the established safety and effectiveness of the legally marketed predicate devices. The FDA's initial approval of those predicate devices would have relied on various forms of evidence, potentially including expert consensus, non-clinical tests, and prior clinical experience.
• 8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the "study" that proves the device meets the acceptance criteria is the 510(k) submission process itself, which involves a detailed comparison of the Cranion™ Cranial Fixation System to a list of predicate devices from Bioplate, Inc. The acceptance criteria are primarily substantial equivalence in intended use and technical characteristics, leading to no new safety or efficacy issues.

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