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K Number
K033120
Device Name
SCALETRON PIEZO ULTRASOUND SCALER
Manufacturer
PAC-DENT INTERNATIONAL (SUZHOU), LTD.
Date Cleared
2004-01-29

(121 days)

Product Code
ELC
Regulation Number
872.4850
Type
Traditional
Panel
DE
Reference & Predicate Devices
K014238
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Scaletron™ is a Piezo Ultrasonic Scaler intended for use in fast and reliable removal of light to heavy calculus deposits and stains from teeth.

Device Description

The Scaletron ™ consists of the main scaler unit (including a peristaltic water pump), a hose, a connector for handpiece and a foot control switch. It is designed to generate regular linear tip movement at nominal 30 KHz.

AI/ML Overview

This 510(k) premarket notification for the "ScaleTron™ Piezo Ultrasonic Scaler" does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.

The provided document describes the device, its intended use, and states its substantial equivalence to a predicate device (Delsonic 2000™ Piezo Ultrasonic Scaler). The FDA letter confirms the substantial equivalence determination.

Therefore, I cannot provide the detailed information requested in the prompt, such as:

  • A table of acceptance criteria and reported device performance.
  • Sample size used for the test set and data provenance.
  • Number and qualifications of experts for ground truth.
  • Adjudication method.
  • MRMC comparative effectiveness study results.
  • Standalone performance.
  • Type of ground truth used.
  • Sample size for the training set.
  • How ground truth for the training set was established.

This is because the 510(k) pathway for medical device clearance in this instance relies on demonstrating substantial equivalence to an already legally marketed predicate device, rather than requiring extensive new performance studies with specific acceptance criteria that would typically be detailed in a clinical or performance study report. The substantial equivalence argument is often supported by comparisons of technological characteristics, materials, and intended use, and may not involve a direct "study" in the sense of a clinical trial with acceptance criteria for a new AI/software device.

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.