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General indications: The Inion CPS" Baby 1.5 Bioabsorbable Fixation System is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, midface and maxilla.

Specific indications:

• Fractures of the cranium, midface and maxilla. .
• Infant craniofacial surgery (i.e. craniosynostosis, congenital . malformations).
• LeFort (I, II, III) osteotomies. ●
• Pediatric reconstructive procedures. ●
• Orthognathic or reconstructive procedures of the cranium, midface or ● maxilla.
• . Craniotomy flap fixation.

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This is a 510(k) premarket notification for a medical device (Inion CPS™ Baby 1.5 Bioabsorbable Fixation System), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, experts, and comparison to AI performance is not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K010351) for the same intended use. It describes the device, its intended use, classifications, and the FDA's clearance.

There is no information within this document that describes:

• Acceptance criteria for an AI/ML model's performance.
• Any study proving a device meets such criteria through a performance evaluation using a test set.
• Data provenance, expert ground truth establishment, adjudication methods, or MRMC studies.

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