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K Number
K980760
Device Name
KLS-MARTIN MMF SCREW
Manufacturer
KLS-MARTIN L.P.
Date Cleared
1999-12-21

(662 days)

Product Code
DZL
Regulation Number
872.4880
Type
Traditional
Panel
DE
Reference & Predicate Devices
K963030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The KLS-Martin MMF Screw is intended for use in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both.

Device Description

The KLS-Martin MMF Screws provide temporary occlusal and fracture stabilization which can be achieved within a matter of minutes. These screws may be applied prior to or after exposure of the fracture.

AI/ML Overview

The provided text does not contain information on acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the KLS-Martin MMF Screw, which primarily focuses on its substantial equivalence to a predicate device for regulatory approval.

Specifically, the text includes:

  • 510(k) Summary: This section describes the device, its intended use, and comparison to a predicate device (Leibinger IMF Screw: K963030).
  • FDA Letter: This letter from the FDA confirms the review of the 510(k) notification and a determination of substantial equivalence, allowing the device to be marketed.
  • Indications for Use: This section reiterates the intended use of the device.

There is no information present regarding:

  1. A table of acceptance criteria or reported device performance.
  2. Sample size used for a test set, data provenance, or retrospective/prospective nature of a study.
  3. Number or qualifications of experts used to establish ground truth.
  4. Adjudication method.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study, including a human-AI effect size.
  6. Standalone performance study.
  7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document is a regulatory submission for substantial equivalence based on comparison to an existing device, not a performance study demonstrating specific acceptance criteria.

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.