LogoFDA 510(k) Search
K Number
K014068
Device Name
ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
Manufacturer
W & H DENTALWERK BUERMOOS GMBH
Date Cleared
2002-05-03

(144 days)

Product Code
EBW
Regulation Number
872.4200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Indications are very widespread in the field of oral surgery.

  • A. Implant placement, including
      1. preparation of the osteotomy site
      1. bone reconturing, osteoplasty
  • B. Bone grafting
      1. granns
    1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
      1. harvesting autogen living bone
      1. sinus elevation & grafting of alveolar sockets
  • C. Removal and sectioning of teeth ant teeth bone for e.g. impacted third molars and complicated extractions
  • D. Periodontal surgeries
      1. bone recontouring & alveoplasty around living teeth
      1. removal of exoslosis
  • E. Endodontic treatment
      1. Intracanal preparations using rotating NiTi-files
Device Description

elcoMED SA-200 and elcoMED SA-200 C consist of a small hand held motor, a foot control and a controller. The system components connect to each other via a proprietary coupling system.

AI/ML Overview

The provided 510(k) summary for the elcoMED SA-200 and SA-200 C devices does not contain information related to specific acceptance criteria, performance studies, or AI/ML aspects.

This submission is for a dental surgical unit, which is a physical device, and the information provided focuses on its technical characteristics, intended use, and substantial equivalence to a predicate device (elcomed 100). The typical contents of a 510(k) for such a device do not usually include the kind of detailed performance study data, ground truth establishment, or AI/ML-specific metrics that your request outlines.

Therefore, I cannot extract the requested information from the provided text.

Specifically, the following information is not available in the provided document:

  1. A table of acceptance criteria and the reported device performance: This document primarily discusses the device's technical specifications and intended use, not performance metrics against acceptance criteria.
  2. Sample size used for the test set and the data provenance: No performance test data is presented.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such study is described.
  4. Adjudication method for the test set: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable as this is not an AI/ML diagnostic or image analysis device.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

The submission is a standard 510(k) for substantial equivalence of a physical medical device, not a software or AI/ML-driven device that would require the types of criteria and studies you've asked about.

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.