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K Number
K051341
Device Name
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059
Manufacturer
INION LTD.
Date Cleared
2005-05-27

(4 days)

Product Code
JEY
Regulation Number
872.4760
Type
Special
Panel
DE
Reference & Predicate Devices
K010351,K992355,K971870
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • General indications: The INION CPSTM BABY 1.5 BIOABSORBABLE FIXATION A. SYSTEM is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face and maxilla.
  • B. Specific indications:
    • · Fractures of the cranium, mid-face and maxilla
    • · Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations)
    • · LeFort (1, II, III) osteotomies
    • · Pediatric reconstructive procedures
    • · Orthognathic or reconstructive procedures of the cranium, mid-face, or maxilla
    • · Craniotomy flap fixation
Device Description

The Inion CPS™ Baby 1.5 Bioabsorbable Fixation System is indicated for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face and maxilla. The new 40-hole plate and 64-hole plate are identical with the other implants in the previously 510(k) cleared Inion CPS™ Baby 1.5 Bioabsorbable Fixation System (K010351) in terms of copolymer composition, intended use and indications for use as described in the device labelling, manufacturing method, sterilization method and packaging solution.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary for a "Special 510(k)" for a line extension of an existing bioabsorbable fixation system. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing performance data against specific acceptance criteria.

The document states: "No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application." This further indicates that no specific performance benchmarks or studies against them would be presented in this type of submission summary.

Therefore, I cannot provide the requested information in the table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies.

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.