(14 days)
The INION CPS™ BABY 1.5 BIOABSORBABLE FIXATION SYSTEM is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face and maxilla. Specific indications: Fractures of the cranium, mid-face 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, mid-face, or maxilla; Craniotomy flap fixation.
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. Specific indications: Fractures of the cranium, mid-face 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, mid-face, or maxilla; Craniotomy flap fixation. The new large X plate is identical with the other implants in the previously 510(k) cleared Inion CPSTM 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.
The provided text is a 510(k) summary for a medical device (Inion CPS™ Baby 1.5 Bioabsorbable Fixation System). It focuses on establishing substantial equivalence to a predicate device and discusses product specifications, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a dataset analysis.
The document states:
- "No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application." This suggests that the primary evaluation was against existing standards and predicate devices, rather than a specific performance study with acceptance criteria.
- "Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion CPS™ Baby 1.5 Bioabsorbable Fixation system large X plate are substantially equivalent with the other Inion CPS™ Baby 1.5 Bioabsorbable Fixation system (K010351) implants as well as the predicate device Howmedica Leibinger Resorbable Fixation System (K982531)." This highlights the reliance on equivalence to predicate devices, not a standalone performance study as described in your prompt's questions.
Therefore, I cannot extract the requested information based on the input document as it does not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, or adjudication methods for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance study.
- Type of ground truth used for a test set.
- Sample size for the training set or how its ground truth was established.
This document is a regulatory submission focused on demonstrating substantial equivalence of a new design (large X plate) to an already cleared device and a predicate device under 510(k) regulations, rather than a clinical or performance study report with specific acceptance criteria as you've outlined.
§ 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.