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K Number
K961421
Device Name
SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM
Manufacturer
SYNTHES (USA)
Date Cleared
1996-06-26

(75 days)

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

The Synthes 2.4 mm ULPS is a plate and screw system, that is intended for mandible trauma and reconstruction procedures.

Device Description

The Synthes 2.4 mm Universal Locking Plate System is a plate and screw system intended for mandible trauma and reconstruction procedures. The plates attach to bone via self-tapping cortex and/or locking screws, and are available in various shapes and sizes. The plates feature compression screw holes that are internally threaded to accept the 2.4 mm - 3.0 mm locking screws. The system includes Threaded Drill Guides and 2.4 mm Insert Screws. The device is provided non-sterile and requires moist heat sterilization prior to use.

AI/ML Overview

This document pertains to a 510(k) summary for a medical device (Synthes 2.4 mm Universal Locking Plate System). It does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of diagnostic or AI-driven performance as described in your request.

The document discusses:

  • Device description: Synthes 2.4 mm Universal Locking Plate System, intended for mandible trauma and reconstruction.
  • Components: Plates, self-tapping cortex and/or locking screws, threaded drill guide, 2.4 mm insert screw.
  • Sterilization: Device provided non-sterile, recommendations for moist heat sterilization provided.
  • Equivalence claim: Based on mechanical test results, the manufacturer believes the devices are "at least equivalent" to the Synthes 2.7 mm Reconstruction Plate System.

Therefore, I cannot extract the information requested as it is not present in the provided text. The terms like "acceptance criteria," "device performance," "sample size," "ground truth," "experts," "adjudication," "MRMC study," "standalone performance," and "training set" are irrelevant to the content of this 510(k) summary, which focuses on a physical medical implant and its safety/equivalence from a mechanical perspective.

§ 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.