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The Inion CPS" 2.5/2.8 Screws are intended for use in trauma and reconstructive procedures in the craniofacial skeleton, midface, maxilla and mandible (in conjunction with appropriate maxillomandibular fixation) as a part of the Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System.
a) Fractures of the cranium, midface, maxilla and mandible.
b) Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations).
c) LeFort (I, II, III) osteotomies.
d) Pediatric reconstructive procedures.
e) Orthognathic or reconstructive procedures of the cranium, midface, maxilla or mandible.
f) Craniotomy flap fixation.

The Inion CPS " Screws are not intended for use in and is contraindicated for: Mandibular tumor resection: Active or potential infection; Patient conditions including limited blood supply, insufficient quantity or quality of bone; and where patient cooperation cannot be guaranteed (e.g., alcoholism, drug abuse). The system is not intended for use in the mandible without appropriate maxillomandibular fixation.

The Inion CPS" 2.5/2.8 Screw is provided with diameters of 2.5 mm and 2.8 mm. Length of the screw is 6 to 23 mm. The Inion CPS™ 2.5/2.8 Screws are made of PLDLA/TMC, same basic material as with predicate device.

The provided text is a 510(k) summary for a medical device (Inion CPS™ 2.5/2.8 Screw) and an associated FDA letter. This type of document is for premarket notification and focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving those criteria are met for a new, de novo device or AI/ML product.

Therefore, the document does not contain the information requested in the prompt's numbered list (acceptance criteria, device performance, sample size, ground truth details, expert qualifications, adjudication, MRMC studies, or standalone performance). The document explicitly states the device is a modification to a currently marketed system and that "there is no change in safety or efficacy," implying that extensive new studies for novel performance criteria are not required for this type of submission.

The core of the submission is to demonstrate equivalence to the predicate device, Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System (K010352), not to establish and prove new performance criteria in the way an AI/ML device would.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text, as this information is not present in the document.

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