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K Number
K973275
Device Name
KLS-MARTIN INTRAORAL DISTRACTOR
Manufacturer
KLS-MARTIN L.P.
Date Cleared
1997-11-20

(79 days)

Product Code
MQN
Regulation Number
872.4760
Type
Traditional
Panel
DE
Reference & Predicate Devices
K962272
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The KLS-Martin Intraoral Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required. (Micrognathia, Hemifacial Microsomia, Congenital Craniofacial Syndromes)

Device Description

The KLS-Martin Intraoral Distractor is a subcutaneous bone distractor. It features two telescoping components activated by a jack screw, fixed to the bone via subcutaneous plates and secured with 1.5mm bone screws. A hex driver is used to activate the required distraction.

AI/ML Overview

The provided text is a 510(k) summary for the KLS-Martin Intraoral Distractor, a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving device performance against specific acceptance criteria through a clinical study in the way modern AI/software as a medical device (SaMD) clearances would.

Therefore, the document does not contain the information requested regarding acceptance criteria or a study proving the device meets them, especially in the context of AI/SaMD.

Here's why and what's missing:

  • Type of Device: The KLS-Martin Intraoral Distractor is a physical surgical implant (a bone distractor), not an AI/software device. Its clearance would typically rely on mechanical testing, biocompatibility, and comparison to a predicate device for safety and effectiveness, rather than performance metrics like sensitivity, specificity, or reader studies.
  • 510(k) Pre-1997 Context: This 510(k) was submitted in 1997. The regulatory landscape for medical devices, particularly regarding clinical data requirements and performance metrics, was different from today, and certainly from what is expected for AI/SaMD.
  • Focus of the Document: The 510(k) summary focuses on device description, intended use, and comparison to a predicate device (Synthes Mandible Distractor K962272) to establish substantial equivalence. It confirms that the device is "substantially equivalent" to a legally marketed device, implying similar safety and effectiveness without necessarily requiring a new, extensive clinical trial demonstrating novel performance against defined metrics.

Therefore, I cannot populate the requested table or answer the specific questions because the provided text does not contain that type of information. This document clears a physical device based on equivalence, not through a performance study against acceptance criteria in the manner requested for AI/SaMD.

§ 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.