K Number
K050354
Date Cleared
2005-03-21

(35 days)

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

The Sirona Dental Systems PerioScan Ultrasonic Scaler is an ultrasonic scaler intended for use in the following dental and periodontal applications:

  • Removal of supragingival and subgingival calculus .
  • Periodontal therapy .
  • Preparing proximal cavities (micropreparation) .
  • Seating tooth-colored inlays and onlays with highly thixotropic dual . curing cements
  • Root canal irrigation .
  • Retrograde root canal treatment ●
Device Description

The Sirona PerioScan Ultrasonic Scaler consists of a table-top unit with two detachable irrigant bottles with lids, a footswitch, an ultrasonic handpiece, hoses and connectors, a variety of optional tips for different dental procedures, and a tool for attaching the tips to the handpiece.

The PerioScan table-top houses the operator input and controls for the supply of irrigant, cooling liquid and light for the handpiece. The device is connected to 115V mains power supply and it may be connected to an external water-supply. The irrigant for the handpiece is drawn from either of the two internal liquid containers or an external water supply. The handpiece is connected to the table-top unit via a hose and can be deposited in the claw. A footswitch with two single switches controls the handpiece. The PerioScan Handpiece is an electrically operated scaler driven by a piezo oscillator. The handpiece includes an illumination LED located in the hose and a spray water controller.

AI/ML Overview

This document is a 510(k) summary for the Sirona Dental Systems PerioScan Ultrasonic Scaler. As such, it does not contain the detailed study results, acceptance criteria, or performance data typically found in a full clinical or engineering report.

The purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove efficacy or safety through new clinical studies. Therefore, much of the requested information regarding detailed acceptance criteria and specific study designs is not present in this summary.

However, based on the provided text, I can infer the following:

1. Table of Acceptance Criteria and Reported Device Performance

Strict acceptance criteria and quantified device performance metrics are not explicitly stated in this 510(k) summary. The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting pre-defined numerical performance targets.

Instead, the "performance" demonstrated is that the Sirona PerioScan is "substantially equivalent" to the EMS Piezon Master 600 (K022328) in terms of:

  • Intended Use: Both devices are ultrasonic scalers for similar dental and periodontal applications.
  • Technical Features: Both include dental handpieces and ultrasonic generators, control software for ultrasonic power, various tip configurations, adjustable ultrasonic power, and irrigation systems (internal containers and external water sources).
  • Principles of Operation: Both operate on the same fundamental principles of ultrasonic scaling.

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable or not specified in the provided 510(k) summary. A 510(k) substantial equivalence submission typically relies on a comparison of device characteristics and intended use, often without requiring new clinical trials or "test sets" in the sense of a new performance study. The data provenance is the device's design specifications and comparison to the predicate.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided and is generally not part of typical 510(k) substantial equivalence submissions for this type of device. There's no mention of a separate "test set" requiring expert ground truth establishment.

4. Adjudication Method

This is not applicable or not specified as there's no mention of a clinical or performance study with a test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study is not mentioned in this 510(k) summary. This type of study would typically be used for imaging or diagnostic devices where human reader interpretation is critical, and the AI's impact on that interpretation is being evaluated. An ultrasonic scaler is a therapeutic device where performance is more directly related to its physical capabilities.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study

This is not applicable or not specified. While the device contains software, the context is a direct-use medical device (ultrasonic scaler) operated by a human, not an autonomous algorithm. The "software" mentioned controls the delivery of ultrasonic power, not an independent diagnostic or therapeutic function requiring a standalone study.

7. Type of Ground Truth Used

Not explicitly defined in the context of a "ground truth" for a performance study. The "ground truth" for this 510(k) submission is effectively the predicate device's established safety and effectiveness. The Sirona PerioScan demonstrates its "truth" by being sufficiently similar to the already cleared predicate.

8. Sample Size for the Training Set

This is not applicable or not specified. As a substantial equivalence submission for an ultrasonic scaler, the concept of a "training set" for an AI model (in the machine learning sense) is not relevant to the information provided. The device uses software for control, not for learning from data.

9. How the Ground Truth for the Training Set Was Established

This is not applicable or not specified for the same reasons as point 8.

§ 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.