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K Number
K030448
Device Name
OSTEOMED 2.0 LOCKING PLATES AND SCREWS
Manufacturer
OSTEOMED L.P.
Date Cleared
2003-05-09

(87 days)

Product Code
JEY
Regulation Number
872.4760
Type
Traditional
Panel
DE
Reference & Predicate Devices
K974555,K000594,K014263
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Indicated for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities). 2.0 Locking plates and screws are intended for single patient use only.

Device Description

The OsteoMed 2.0 Locking Plate System is comprised of plates, 1.0mm through 2.25mm thick, provided in various shapes and sizes, and screws provided in 2.0mm diameter in lengths ranging from 6.0mm. System instruments include screwdrivers, drills, plate cutters, bending pliers, taps and drill guides.

AI/ML Overview

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) summary for the OsteoMed 2.0 Locking Plate System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of materials, design, and intended use.

The document does not contain any information about acceptance criteria for device performance, nor does it describe any study related to proving such criteria for the OsteoMed 2.0 Locking Plate System. This is typical for 510(k) submissions where clinical studies or performance testing against specific acceptance criteria for aspects like diagnostic accuracy (which would involve AI, human readers, ground truth, etc.) are generally not required unless new safety or effectiveness issues are raised.

Therefore, I cannot provide:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for test sets.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication methods.
  5. MRMC comparative effectiveness study details (effect size, human readers with/without AI).
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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.