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K Number
K043434
Device Name
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM
Manufacturer
OSTEOMED L.P.
Date Cleared
2005-02-10

(59 days)

Product Code
MQN
Regulation Number
872.4760
Type
Traditional
Panel
DE
Reference & Predicate Devices
K010139,K013618
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Intended as a bone stabilizer and lengthening (and/or transport) device when correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, symphisis), require gradual distraction. This system is intended for use in pediatric population for children under 4 years of age including infants and neonates. The OsteoMed Pediatric Intraoral Mandibular Distraction System is intended for single patient use only.

Device Description

The OsteoMed Pediatric Intraoral Mandibular Distraction System is a subcutaneous bone distractor. It features various curved and straight bars. activated with a threaded wire, that have plates that are fixed to bone via 1.2mm bone screws. The distractor is available in right and left versions. The threaded wire is activated by a hex driver and is capable of distraction lengths of up to 35mm.

AI/ML Overview

The provided text describes the OsteoMed Pediatric Intraoral Mandibular Distraction System (K043434), a medical device. However, it does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a medical device submitted to the FDA. Such summaries primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed study results against specific acceptance criteria.

Therefore, I cannot fulfill your request for the detailed table and study information because the provided input lacks the necessary data.

To answer your request, the input document would need to include sections detailing:

  1. Specific performance metrics the device was designed to achieve (acceptance criteria).
  2. A study design that evaluated these metrics.
  3. Results from that study, comparing them to the acceptance criteria.
  4. Information on the data used (sample size, provenance), ground truth establishment (experts, adjudication), and training set details (if applicable for an AI device, which this is not).

§ 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.