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K Number
K072764
Device Name
KLS MARTIN XTERNAL FIXATOR
Manufacturer
KLS MARTIN L.P.
Date Cleared
2007-12-20

(83 days)

Product Code
MQN,MON
Regulation Number
872.4760
Type
Traditional
Panel
DE
Reference & Predicate Devices
K071628,K050378,K901095
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

KLS Martin Xternal Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

Device Description

The KLS Martin Xternal Fixator consists of 3.2mm titanium pins in various lengths that are fixated to the bone. The titanium pins are held in place with titanium pin clamps and a 4mm titanium rod or can be held in place with an acrylic bar and titanium screw caps.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the KLS Martin Xternal Fixator, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting performance criteria and study results in the manner you've requested.

Therefore, I cannot fulfill your request for the following information based on the input:

  1. A table of acceptance criteria and the reported device performance
  2. Sample size used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and their qualifications
  4. Adjudication method for the test set
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance
  6. If a standalone (algorithm only) performance study was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

This document primarily describes the device, its intended use, and its similarities and differences to predicate devices to establish substantial equivalence for regulatory clearance. It does not include specific performance studies or acceptance criteria typically found for diagnostic or AI-driven devices.

§ 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.